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Running Therapy Running therapy rivals antidepressant medication for the treatment of depression and anxiety, results of a new study show. However, running provides greater physical health benefits while adherence is greater with drug treatment. "Both interventions helped with the depression to around the same extent," study presenter Brenda W.J.H. Penninx, PhD, professor of psychiatric epidemiology at the VU University Medical Center in Amsterdam, the Netherlands, said in a release. However, medication "generally had worse impact on body weight, heart rate variability, and blood pressure, whereas running therapy led to improved effect on general fitness and heart rate," Penninx added. The findings were presented here at the 36th European College of Neuropsychopharmacology (ECNP) Congress, and recently published in the Journal of Affective Disorders. Research Gap Previous research suggests exercise interventions can have a therapeutic effect equivalent to antidepressants, but their impact on physical health has been "poorly examined in a psychiatric population, the investigators note. The authors note that depressive and anxiety disorders "cause immense suffering by compromising both mental and physical health," and the need for effective treatments is "pressing." Although antidepressant medication is considered a "standard first-line treatment" alongside psychotherapy, the drugs are "not effective for all and [are] often associated with side effects." The Mood Treatment with Antidepressant or Running (MOTAR) study was a partially randomized pragmatic trial in adults with depression and/or anxiety disorder, as determined using the DSM-IV algorithms with the Composite International Diagnostic Interview (CIDI). The 16-week intervention study included 141 patients with depression and/or anxiety. The mean age was 38.2 years and 58% were women. Participants were offered a choice of treatment: 16 weeks of treatment with the selective serotonin reuptake inhibitor (SSRI) escitalopram (Lexapro) or a 16-week group-based running therapy. Patients without a strong preference for treatment allocation were randomly assigned to either antidepressant medication or running therapy, while those unwilling to be randomized were allocated to their preferred intervention. A total of 22 patients were randomly assigned to receive antidepressant treatment and 13 to running therapy. A total of 36 participants chose antidepressant treatment, while 83 chose the running therapy. Running therapy involved 16 weeks of supervised 45-minute outdoor running sessions to a target of two to three sessions per week, in line with US Centers for Disease Control/American College of Sports Medicine recommendations. Physical Health Benefits Treatment adherence in the antidepressant group, defined as still using treatment at the post-treatment assessment, was 82.2% vs 52.1% among running therapy participants, where adherence was specified as completing more than 22 sessions. Remission was defined as no longer meeting the criteria of a current depressive or anxiety disorder via CIDI at week 16. On intention-to-treat analysis, this requirement was met by 44.8% of patients taking antidepressants and 43.3% of those in the running therapy group (P = .88). However, running therapy patients showed significant improvements in weight (P = .001), waist circumference (P = .011), systolic and diastolic blood pressure (P = .011 and P = .002, respectively), heart rate (P = .033), and heart rate variability (P = .006). The investigators note the more favorable physical health changes in the running therapy group were due to "larger improvements in the running therapy group but also due to larger deterioration in the antidepressant group."Antidepressants are generally safe and effective and work for most people, said Penninx. She also noted that untreated depression leads to worse outcomes, so "antidepressants are generally a good choice." Nevertheless, she said, "we need to extend our treatment arsenal as not all patients respond to antidepressants or are willing to take them." The study’s results, she added, suggest that "implementing exercise therapy is something we should take much more seriously, as it could be a good, and maybe even better, choice for some of our patients." Francesca Cirulli, PhD, senior researcher and group leader at the National Institute of Health, Rome, Italy, told Medscape Medical News the study is notable because it is one of the first to prospectively measure the effects of antidepressants and running on physical health. Cirulli suggested that running therapy could be tried ahead of treatment with antidepressants if patients prefer physical exercise and can adhere to it. However, she said, the findings also suggest that an increase in physical activity should accompany treatment with antidepressant medications. Overall, Cirulli said "the message should not be that everyone can be helped by running and antidepressants are bad," but rather "these are both helpful, but not excellent, interventions against depression." Important Limitations Commenting on the research Eduard Vieta, MD, PhD, chair of the Department of Psychiatry and Psychology at the University of Barcelona Hospital Clinic, Barcelona, Spain, noted the study has "very important limitations." Among the limitations: the inclusion of nonrandomized patients who received the treatment of their choice, causing obvious bias and the "lack of binding and power issues" over the number of patients enrolled. Vieta also told Medscape Medical News that the results "seem obvious, because it is known that exercise improves physical health." The trial therefore shows, "if you can find people who are able to do exercise while depressed and adhere to it, those would benefit from that practice," he noted. Also commenting on the research, Eric Ruhe, MD, PhD, Radboud University Medical Center, Nijmegen, the Netherlands, said the results are confirmatory and "again show physical health can influence mental health." However, Ruhe underlined, while it is "common practice" to allow patients to follow their treatment preference and is "understandable from a pragmatic point of view," the group comparison may be "biased" compared to a "truly randomized study." "For example, patients in the antidepressant group were more depressed, which might be associated with less chance of persisting engagement in the exercises," he said. "So, we have to be careful not to overinterpret the comparisons between groups, which the authors acknowledge properly." Turning to the difference in adherence between the two interventions, Ruhe said the results show adopting, and adhering to, a lifestyle habit is more difficult than taking a pill. "This is not exclusively found in psychiatry, indicating that we also have to focus on how to improve compliance to healthy behavior. This could have tremendous impact on healthcare more generally, but also on psychiatric diseases," Ruhe said. Source: MOTAR study was funded by a NWO-VICI grant. Funding for the inflammatory markers was provided by ZonMw: The Netherlands Organization for Health Research and Development.

A cancer diagnosis can bring feelings of confusion, anxiety, sadness, and helplessness. Many mesothelioma patients may feel overwhelmed as they search for stress reduction techniques while navigating their busy treatment schedule. There are many resources available for emotional support for cancer patients and their families, some of which are easy to practice at home. Mindfulness can help patients and their loved ones stay hopeful during a mesothelioma diagnosis. Mindfulness is awareness that arises when we purposely pay attention in the present moment without judgment. Mindfulness-based stress reduction (MBSR) programs can greatly impact cancer patients to manage their stress, pain, and illness. Cancer patients experience a variety of symptoms due to their condition and treatment side effects. MBSR has been proven to be effective in managing stress, anxiety, fatigue, headaches, and high blood pressure. Mesothelioma patients can expect to participate in interactive activities to engage and promote mindfulness meditation. Cancer patients will participate in support activities such as guided mindfulness practice, gentle stretching, yoga, and other activities to promote mindfulness to help them manage their illness. Classes will also provide patients with daily at-home activities to practice their mindfulness meditation skills in the comfort of their own home. Cancer patients and caregivers can both benefit from the techniques and practices of MBSR to reduce stress during their journey navigating a cancer diagnosis. Source: Kaitlyn Carlock- Advocacy Associate https://www.mesotheliomahope.com/

Here is the basic principles behind Dr. Carl Jung's excerpt on how to own your yourself. Carl Jung (1875-1961) Carl Jung was an early 20th century psychotherapist and psychiatrist who created the field of analytical psychology. He is widely considered one of the most important figures in the history of psychology. Early Life Carl Gustav Jung was born in Switzerland in 1875 to Emilie Preiswerk and Paul Jung, a pastor. Because of his father’s faith, Jung developed a keen interest in religious history, but he settled on the study of medicine at the University of Basel. After he completed his medical degree, Jung joined the staff at Burghoelzli Clinic in Zurich, Switzerland as an intern to Eugen Bleuler, where he explored the unconscious mind and its related complexes. He also traveled to Paris to study under Pierre Janet in 1902. In 1905, Jung was appointed to the faculty at the University of Zurich where he worked until 1913. Jung married Emma Rauschenbach in 1903. The couple had five children and remained married until Emma's death in 1955, although Jung's extramarital affairs were extensive. Jung died in Switzerland in 1961. Professional Life Jung sent a copy of his book Studies in Word Association to Sigmund Freud in 1906, and Freud reciprocated by inviting Jung to visit Vienna. Their friendship lasted until 1913, at which time they parted ways due to a difference in academic opinion. Jung agreed with Freud’s theory of the unconscious, but Jung also believed in the existence of a deeper collective unconscious and representative archetypes. Freud openly criticized Jung's theories, and this fundamental difference caused their friendship and psychological views to diverge. Jung traveled throughout the world to teach and influence others with his psychoanalytical theories. He published many books relating to psychology, and others that seemed outside the realm science, including Flying Saucers: A Modern Myth of Things Seen in the Skies , which examined and dissected the psychological significance of UFO sightings. Jung’s work embodied his belief that each person has a life purpose that is based in a spiritual self. Through his eastern, western, and mythological studies, Jung developed a theory of transformation called individuation that he explored in Psychology and Alchemy , a book in which he detailed the relationship of alchemy in the psychoanalytical process. Source: GoodTherapy (2023)

In some cases, a recent stressors or sudden catastrophic event, failure or can leave people feeling desperate, unable to see a way out, and become a "tipping point" toward suicide. Suicide is one of the leading causes of death in the United States. It is the second leading cause of death for people aged 10 to 34. The highest rate of suicide occurs in persons 75 years of age or older. The impact of suicide in communities makes suicide a serious public health problem. In 2021 in the U.S., more than 47,000 people died by suicide and an there were an estimated 1.2 million suicide attempts according to the Centers for Disease Control and Prevention (CDC). This is one death by suicide every 11 minutes. (1, 2) Men were more than three times more likely than women to take their lives. Firearms are the most common method of suicide (used in about half of all suicides).Yet, suicide is preventable. Knowing the risk factors and recognizing the warning signs for suicide can help prevent suicide. Risk Factors, Warning Signs and Protective Factors Suicide is linked to mental disorders, particularly depression and alcohol use disorders, and the strongest risk factor for suicide is a previous suicide attempt. The Suicide Prevention Resource Center defines risk and protective factors and warning signs: Risk factors are characteristics that make it more likely that an individual will consider, attempt or die by suicide. Warning signs indicate an immediate risk of suicide. Protective factors are characteristics that make it less likely that individuals will consider, attempt or die by suicide. Suicide Prevention Risk Factors for Suicide Individual, relationship, community and societal factors can increase the risk of suicide such as: Previous suicide attempt(s). A history of suicide in the family. Substance use. Mood disorders (depression, bipolar disorder). Access to lethal means (for example, keeping firearms in the home or having access to unsecured prescription medications) Losses and other events (for example, the breakup of a relationship or a death, academic failures, legal difficulties, financial difficulties). History of trauma or abuse. Bullying. Chronic physical illness, including chronic pain. Exposure to the suicidal behavior of others. Social isolation. Historical trauma. Stigma associated with seeking help. In some cases, a recent stressor(s) or sudden catastrophic event, failure or can leave people feeling desperate, unable to see a way out, and become a "tipping point" toward suicide. A CDC report highlights the complexity of suicide.(3) While a mental health condition may be a contributing factor for many people, many factors contribute to suicide among people with and without known mental health conditions. A relationship problem was the top factor contributing to suicide, followed by crisis in the past or upcoming two weeks and problematic substance use. About half, 54 percent, of people who died by suicide did not have a known mental health condition, according to CDC.(4) However, many of them may have been dealing with mental health challenges that had not been diagnosed or known to those around them. Warning Signs of Suicide Often talking or writing about death, dying or suicide. Making comments about being hopeless, helpless or worthless. Expressions of having no reason for living; no sense of purpose in life; saying things like "It would be better if I wasn't here" or "I want out." Increased alcohol and/or drug use. Withdrawal from friends, family and community. Reckless behavior or more risky activities, seemingly without thinking. Dramatic mood changes. Talking about feeling trapped or being a burden to others. Protective Factors Contacts with providers (such as, follow-up phone call from health care professional). Effective mental health care; easy access to a variety of clinical interventions. Feelings of strong connections to individuals, family, community and social institutions. Strong sense of cultural identity. Problem-solving and conflict resolution skills. The CDC recommends a comprehensive public health approach to suicide prevention and it identifies several strategies that states and communities can undertake, including such measures as teaching coping and problem-solving skills to help people manage challenges, expanding options for temporary assistance for those in need and connecting people at-risk to effective and coordinated mental and physical health care. What You Can Do 988 Suicide Crisis and Lifeline has developed five steps to take to support a loved one that may be experiencing suicidal thoughts. Ask someone you are concerned about if they're thinking about suicide. Studies show that asking someone if they are having thoughts of suicide does not increase the likelihood of a completed suicide nor does it increase suicidal thoughts. Be there for them. This could be by phone or in person. Keep them safe. Reduce access to lethal means for those at risk. Help them connect with ongoing support. Follow up. Give them a call or visit. Send a text or an email to let them know that you are still present. Learn more and find resources at www.BeThe1To.com. Be the one to save a life. You can do something to prevent suicide. If you need help for yourself or someone else, contact the Suicide and Crisis Lifeline by calling or texting 988. You can also chat online at 988lifeline.org. Resources Crisis Resources - American Association of Suicidology Veteran's Administration Suicide Prevention Get Help - American Foundation for Suicide Prevention (AFSP) World Health Organization - Suicide Prevention Suicide Prevention Resource Center Suicide & Self Harm Injury Data, Centers for Disease Control and Prevention. We Can All Prevent Suicide : Lifeline (988lifeline.org) Take 5 to Save Lives References Centers for Disease Control and Prevention. 2022. Provisional Numbers and Rates of Suicide by Month and Demographic Characteristics: United States, 2021. Curtin, S.C., et al authors. Vital Statistics Rapid Release Report No. 24, September 2022. CDC. Facts about Suicide. https://www.cdc.gov/suicide/facts/index.html CDC. 2018. Fact Sheet: Suicide Rising Across the U.S. (.pdf) Centers for Disease Control and Prevention. Stone, et al. Vital Signs: Trends in State Suicide Rates – United States, 1999-2016 and Circumstances Contributing to Suicide – 27 States, 2015. Morbidity and Mortality Weekly Report. June 8, 2018. Vol.67, No.22.

Narcolepsy TOPLINE: Solriamfetol ― a medication approved for excessive daytime sleepiness caused by narcolepsy or obstructive sleep apnea ― significantly improved symptoms of attention-deficit/hyperactivity disorder (ADHD) and clinical impression of ADHD severity in a pilot study of adults with ADHD. METHODOLOGY: Solriamfetol is a dopamine and norepinephrine reuptake inhibitor that shares some of the properties of current ADHD medications. Researchers conducted a randomized, double-blind, placebo-controlled, dose-optimization trial of 75- or 150-mg solriamfetol in 60 adults with ADHD. For nearly all of the individuals who received solriamfetol, doses increased to 150 mg after the first week. The primary outcome was change in scores on the Adult ADHD Investigator Symptom Rating Scale (AISRS). Secondary outcomes included scores on the Clinical Global Impressions (CGI) scale and standard measures of executive function, behavior, and sleep. TAKEAWAY: By week 6, total AISRS score improved 25% for 52% of individuals to took solriamfetol, vs 17% of those who received placebo. Total AISRS score improved 50% by week 6 in 28% of those who took solriamfetol, vs 3.4% of those who received placebo. By week 6, CGI ratings of "much improved" or "very much improved" occurred in significantly more individuals who received solriamfetol than those who took placebo (45% vs 7%). Significantly more individuals who received solriamfetol than placebo self-reported improvements in executive function (69% vs 34%). Improvement in wakefulness was noted with solriamfetol, but that did not moderate the change in ADHD symptom burden. Solriamfetol was well tolerated, with no significant effect on sleep quality or blood pressure. Adverse effects that occurred at a higher rate in the treatment group than in the placebo group were typical for solriamfetol and sympathomimetic agents used for ADHD. IN PRACTICE: "Solriamfetol may be a safe and effective treatment for ADHD in adults. Larger studies replicating these findings could confirm the strong evidence of benefit and the tolerability of this agent as a treatment," lead author Craig B. H. Surman, MD, director of the Clinical and Research Program in Adult ADHD, Massachusetts General Hospital, said in a statement.

How Many Hours a Day Do You Waste? Amazing video by Dr. Jordan Peterson about how productive we could be if we paid attention to the amount of time we waste each day. Productivity leads to longer longevity and satisfaction out of time... By Dr. Jordan Peterson Source: Dr. Jordan Peterson

Imagine it’s your birthday. You’re expecting a phone call from a close friend, but it never comes. You called them on their birthday, so why didn’t they call you? Do they not care enough to remember your birthday? You feel hurt. Where did this feeling of hurt come from? It wasn’t the lack of a phone call that caused the hurt. It was the thoughts about the lack of a phone call that hurt. What if, instead of taking the missing phone call personally, you had thought: Thoughts play a powerful role in determining how people feel and how they act. If someone thinks positively about something, they’ll probably feel positively about it. Conversely, if they think negatively about something—whether or not that thought is supported by evidence—they will feel negatively. Cognitive restructuring is the therapeutic process of identifying and challenging negative and irrational thoughts, such as those described in the birthday example. These sort of thoughts are called cognitive distortions. Although everyone has some cognitive distortions, having too many is closely linked to mental illnesses such as depression and anxiety. Cognitive behavioral therapy (CBT), and several other approaches to psychotherapy, make heavy use of cognitive restructuring. Each of these therapies leverages the powerful link between thoughts, feelings, and behaviors to treat mental illness. The thought-feeling-behavior link is a big topic in itself, and beyond the scope of this guide. If you want to learn more, check out our CBT Psychoeducation guide and worksheet. Remember, cognitive restructuring refers to the process of challenging thoughts—it isn’t a single technique. There are many techniques that fall under the umbrella of cognitive restructuring, which we will describe (alongside several therapy tools) throughout this guide. Identifying Negative Thoughts / Cognitive Distortions Cognitive restructuring starts with the identification of irrational negative thoughts (cognitive distortions). This is trickier than it sounds. Cognitive distortions can happen so quickly that they come and go before we’ve noticed them. They’re more like a reflex than an intentional behavior. Below, we’ll discuss how to help your clients identify their cognitive distortions. Step 1: Psychoeducation Before jumping into the “doing” part of cognitive restructuring, it’s important for clients to understand what cognitive distortions are, and how powerful they are in influencing one’s mood. Start with psychoeducation about the cognitive model and cognitive distortions, using plenty of examples. Step 2: Increase Awareness of Thoughts After building a general understanding of the cognitive model, your clients will learn to identify their own cognitive distortions. This takes practice. It’s not natural, during a fit of rage, to stop and wonder: “What thoughts led me to this moment?” To hone in on the most important cognitive distortions, start by looking for negative emotions. When are symptoms of depression, anger, or anxiety at their worst? If your client has difficulty identifying their emotions, focus on behaviors. What behaviors do they want to change? What triggers those behaviors? Think of these situations like alarms, alerting you that cognitive distortions are nearby. This discussion is intended to improve your client’s awareness of situations where cognitive distortions are impacting their mood and behavior. The more specific triggers or situations they can identify, the easier it will be to recognize them in the moment. With the completion of step 2, your client has laid the foundation for a core tool of cognitive restructuring: thought records. Step 3: Thought Records A thought record (also called a thought log) is a tool for recording experiences, along with the thoughts, feelings, and behaviors that accompany them. This exercise will help your clients become aware of cognitive distortions that previously went unnoticed, and unquestioned. With practice, they will learn to identify cognitive distortions in the moment, and immediately challenge them. Each row of a thought record represents a unique situation. The headings for each column will differ slightly between thought records, but generally they include “situation”, “thoughts”, “feelings”, “consequences”, and sometimes, “alternate thought”. Ideally, each row is filled in shortly after a situation ends. Sometimes, the mere awareness of a cognitive distortion will be enough to eliminate it. Other cognitive distortions are more deeply ingrained, and require extra work. This is where cognitive restructuring techniques, which make up the rest of this guide, will come in handy. Cognitive Restructuring Techniques When looking at other people’s cognitive distortions, they seem easy to dispute. No matter how much your friend believes that they’re the “worst person ever”, you know that to be untrue. But when it comes to a person’s own cognitive distortions, they can be much more difficult to overcome. That’s why they persist. We believe in our own cognitive distortions, no matter how inaccurate they may be. For these difficult cognitive distortions, we have several techniques to help tear them down. These techniques should be used again and again, whenever cognitive distortions are identified. With enough repetition, the cognitive distortions will be extinguished and replaced with new, balanced thoughts. Here are the techniques. Socratic Questioning Socrates was a Greek philosopher who emphasized the importance of questioning as a way to explore complex ideas and uncover assumptions. This philosophy has been adopted as a way to challenge cognitive distortions. Once a cognitive distortion has been identified, this technique is simple. The cognitive distortion will be assessed by asking a series of questions. Therapists can set an example by asking these questions of their clients, but ultimately, the client should learn to question their own thoughts. Decatastrophizing Oftentimes, cognitive distortions are just an exaggerated view of reality. Before a first date, a person might find themselves overwhelmed with anxiety, thinking of all the things that might go wrong. Maybe their date won’t like how they look, or maybe they’ll make a fool of themselves. With the decatastrophizing technique, we ask very simple questions: “What if?” or “What’s the worst that could happen?” This sequence of questioning helps to reduce the irrational level of anxiety associated with cognitive distortions. It highlights the fact that even the worst-case scenario is manageable. Putting Thoughts on Trial In this exercise, your client will act as a defense attorney, a prosecutor, and a judge. First, your client will act as a defense attorney by defending their negative thought. Ask them to make an argument for why the thought is true. Remember to stick to verifiable facts. Interpretation, guesses, and opinions aren’t allowed! Next, ask your client to act as the prosecutor. Now they will present evidence against the negative thought. Just like in the previous step, require that they stick to facts, while excluding opinions. Finally, ask your client to act as the judge. They will review the evidence, and deliver a verdict. The verdict should come in the form of a rational thought. If you would like to continue learning about cognitive behavioral therapy, cognitive distortions, and cognitive restructuring. Related Article: Cognitive Distortions Cognitive Benefit of Highly Touted MIND Diet Questioned Cognitive Distortions - CBT

The drug’s developers respond to the FDA’s decision to deny approval and consider future directions for this indication. Information about the US Food & Drug Administration (FDA)’s Complete Response Letter (CRL) for Zurzuvae’s (zuranolone’s) New Drug Application (NDA) for treating major depressive disorder (MDD) may provide some clarity about next steps for the agent. The FDA announced in August that (zuranolone) was approved as a treatment for postpartum depression (PPD) in adults, but not approved for its other proposed indication of MDD.1 Reports note that the FDA cited concerns about safety due to the drug’s adverse effects, a lack of evidence of the drug’s effectiveness, and the need for more studies in order to support approval for the MDD indication.2,3 “The FDA approved zuranolone for the indication of PPD but did not approve it for the second indication of unipolar major depression in women and men,” John J. Miller, MD, told Psychiatric Times®. “…Sage [Therapeutics] and Biogen, collaborators in the zuranolone development project, will need to review the reasons why the FDA denied approval for unipolar major depression in women and men, and determine how to proceed.”1 Miller is Editor in Chief of Psychiatric Times; medical director at Brain Health; a staff psychiatrist at Seacoast Mental Health Center; and a consulting psychiatrist at Exeter Hospital and Insight Meditation Society. In response to the decision, Sage and Biogen have been reviewing the FDA’s feedback in detail in order to determine next steps.3 Sage has also announced that it is cutting around 40% of its workforce following reports that its shares had dropped almost 54% by August 7.4 “In regard to the CRL for MDD, we are highly disappointed for patients, particularly amid the current mental health crisis and millions of people with MDD struggling to find symptom relief,” said Barry Greene, chief executive officer at Sage, in a press release. “We remain committed to our mission to deliver life-changing brain health medicines.”2 Some specific issues in the MDD research cited by the FDA include a patient who was unresponsive to stimuli for 50 minutes following administration of a high dose of zuranolone, and a small number of patients who reported having suicidal thoughts after either starting or stopping zuranolone treatment. It has also been reported that a couple of patients had seizures. 3,4 In the CRL, however, the FDA stated that other factors, such as comorbid conditions and consumption of another drug that lists seizures as a possible adverse effect, may have been the actual cause(s) of the seizures in these patients.5 There have also been positive findings about zuranolone for the treatment of MDD throughout the road to approval. When the rolling NDA submission for zuranolone was completed in December 2022, data from the LANDSCAPE and NEST development programs showed that zuranolone demonstrated rapid and sustained improvement of depressive symptoms, largely good tolerability, and a consistent safety profile.6 Representatives from Sage and other entities have also offered differing views about the MDD research and the FDA’s conclusions. According to Matthew Henson, spokesman for Sage, the patients referenced above had received a double-sized dose of zuranolone.4 And Brian Abrahams, analyst for RBC Capital Markets, has been quoted as saying that the FDA’s conclusions about the overall safety profile of zuranolone “does not appear completely aligned with Sage’s historical interpretations.”3 In addition to determining next steps for MDD, Sage has announced that it is currently focusing on PPD, which it plans to launch in the fourth quarter of 2023. Zuranolone for the treatment of PPD is expected to be commercially available in fourth-quarter 2023 and to potentially draw $240 million in eventual sales.2,4 Related Article: Phase 3 Clinical Program Announced for Monotherapy Treatment for MDD

What can be done to restore balance in healthcare delivery KEY POINTS Mental health care tends to bring in less money than other areas of medicine. Private healthcare organizations are increasingly cutting back on delivering mental health care. There are specific steps that can be taken to reverse the outsourcing of mental health care to the public. Outsourcing of Mental Healthcare Who should be delivering healthcare? Private companies? The government? The debate over what works best will go on for years. As it continues, what clearly isn’t working is this strange hybrid situation we current have in which some aspects of healthcare are predominantly within the private world (including “not for profit” organizations that operate very much like private entities) while others are much more likely administered by federal, state, and local governments. Which type of healthcare goes one way or the other is fairly predictable, and is primarily driven by, big shocker, money. Certain areas of healthcare are simply more profitable than others. Surgery, imaging and radiology, cardiac care – these things tend to bring in dollars so it is no surprise that private healthcare providers build lots of capacity and offer plenty of access for these services. Primary care, not so much, but since primary care clinicians are the ones who often refer patients to these more profitable areas they tend to be tolerated and kept close within the organizational structure. What type of care is at the bottom of the heap? That would be mental health, which tends to be time-intensive, less procedure-based, and disproportionately needed by people with fewer financial resources. If times get tough, then, it can be very tempting to drop the less profitable areas of your business while holding on to the more profitable ones, and this is exactly what has been happening when it comes to large private hospitals and clinics and mental health care. And who is expected to pick up the slack for providing critical areas of care that tend to make less money? That would be you - in the form of state or county clinics that are funded and run by taxpayers. This form of public subsidy that permits private healthcare organizations to retain more profitable sectors of medicine while offloading the less profitable ones to the public has been going on for decades in mental health. In many areas around the county, things have now reached crisis levels, as anyone who has recently needed outpatient or inpatient mental health treatment (and who isn’t wealthy enough to pay out of pocket for it) can well attest. Hospital psychiatry units are closing fast, almost as fast as elective surgery centers are opening up. And while these private healthcare organizations may save money in the short-term, the long-term effect may be to convince more and more people that the whole private healthcare thing is fundamentally flawed and needs to be taken over (all of it) by the government. Short of that, however, there are some things that can help bring this system into better balance. Major healthcare providers are typically subject to regulation, often by state government. These regulatory bodies might consider using this power. Sure, big hospital, you can open up that shiny new vascular surgery center, but you have to keep your inpatient psychiatry unit going as well. Insurance providers, starting with federal and state ones like Medicare and Medicaid, could adjust their payment rates to bring mental health care closer to parity with physical health. Just imagine what might happen if a 3-hour autism evaluation (a complicated and potentially life changing assessment) was compensated anywhere near the rate of a 3-hour procedure or medical test. If this happened, I guarantee you that parents would no longer be waiting a year or more to get their child evaluated. We can continue to move away from traditional “fee for service” models, that provide financial incentives to do as many expensive tests and procedures as possible, to models that pay healthcare organizations a fixed amount of money per individual per month. These “capitated” models tilt the financial incentive the other way, rewarding organizations to keep people healthy. Given the research showing that mental health is a foundation for all health, the value of good mental health care, both preventively and for those already struggling, becomes hard to ignore. In summary, the ability of big private healthcare organizations to simply “opt out” of providing critically needed mental healthcare cannot continue and needs to be actively confronted. It is not the responsibility of the public taxpayer to balance the budgets of big corporations through the outsourcing of mental healthcare to publicly run clinics and hospitals. About Dr. Vilash Reddy a child, adolescent, and adult psychiatrist who is a blend of therapy with modern medicines and/or alternative remedies. He also have a holistic approach to each one of my patients, which can be a fusion of medicine and/or therapy and/or alternative supplements/remedies. And he customize and educate you throughout the process.

The investigators also concluded that depression screening alone may not be sufficient to effectively identify suicide risk. October 5 is National Depression Screening Day. A recent study that compared the effectiveness of suicide screening and several types of depression screenings supported the efficacy of the 9-item Patient Health Questionnaire (PHQ-9) in comparison to other screening tools. However, the study investigators also concluded that depression screening alone may not be sufficient to effectively identify suicide risk. The study, conducted by researchers at the Ohio State University Wexner Medical Center and Wesleyan University, compared the effectiveness of suicide risk screening and depression screening alone among primary care patients. The study included 2744 patients between the ages of 18 and 89 years from 6 primary care clinics who completed several depression screenings—including the self-administered PHQ-9 and the 2-item Patient Health Questionnaire (PHQ-2)—and the suicidal ideation (SI) screening, which focused on “thoughts of killing yourself” within the past week, within the past month, and during one’s entire lifespan.1 Of these patients, 65.4% who screened positive for SI also screened positive for depression on the PHQ-9. The PHQ-9 also accurately identified more patients who had attempted suicide in the past 3 months than lifetime SI—however, lifetime SI accurately identified more patients who had attempted suicide within the past 6 and 12 months. “Our findings indicated depression screening with the PHQ-9 outperformed suicide risk screening under most conditions,” the investigators wrote, ultimately concluding that depression screening alone was not sufficient to identify all patients at risk for suicide.1 “Our results also suggest that supplementing the PHQ-9 with additional SI screening items did not meaningfully improve the identification of primary care patients who attempted suicide, particularly in the near term,” the investigators wrote. “On the contrary, our results suggest the possibility that additional SI screening—particularly screening that focuses on current or recent SI—may have the unintended effect of negatively influencing clinical decision-making.” The study has important implications for suicide prevention efforts. Suicide is a leading cause of death in the United States. According to the Centers for Disease Control and Prevention (CDC), suicide rates have been increasing in recent years, with adults aged 35 to 64 years accounting for nearly half of all suicides in the United States; with adults aged 75 years and older committing suicide at a rate of 20.3 per 100,000 suicides; and with suicide rates for children and young adults aged 10 to 24 years increasing by more than 50% between 2000 and 2021.2 “Our results indicate that depression screening was superior to suicide risk screening under most conditions for the specific purpose of identifying patients who would subsequently attempt suicide, with the PHQ-9 performing the best and screening for ‘thoughts of killing yourself’ within the past week or past month performing the worst,” the investigators concluded. “Use of the PHQ-9 instead of the PHQ-2 could markedly improve the identification of at-risk patients in primary care, particularly those who are most likely to attempt suicide in the short term.” Related Article: Suicide Prevention

“Over 32 weeks of follow-up, the percentage of patients with remission, the percentage of patients with a treatment response, and the change in the MADRS score from baseline favored esketamine nasal spray.” A long-term clinical trial comparing esketamine CIII nasal spray with quetiapine extended release found that esketamine had greater success with inducing remission in participants with treatment-resistant major depressive disorder (MDD). The clinical trial—a randomized, open-label, active-controlled, rater-blinded, phase 3b study called ESCAPE-TRD—aimed to evaluate the efficacy of flexibly dosed esketamine nasal spray (Johnson & Johnson’s Spravato) in comparison with the efficacy of quetiapine extended release, both when combined with a selective serotonin reuptake inhibitor (SSRI) or a serotonin-norepinephrine reuptake inhibitor (SNRI), in patients with treatment-resistant MDD.1 The primary end point of the study was remission, which the investigators defined as a score of 10 or lower on the Montgomery-Åsberg Depression Rating Scale (MADRS) at week 8, and the key secondary end point of the study was for participants not to relapse through week 32 after achieving remission at week 8.2 The investigators assigned 336 participants to the esketamine group and 340 participants to the quetiapine group. Upon analysis at week 8, they noted that more participants in the esketamine group had achieved remission when compared with participants in the quetiapine group (91 of 336 participants [27.1%] vs 60 of 340 participants [17.6%]; P=0.003).2 They also noted that 73 of the 336 (21.7%) participants in the esketamine group experienced no relapse through week 32 after remission at week 8, compared with 48 of 340 (14.1%) participants in the quetiapine group.2 Overall, the participants treated with esketamine nasal spray were 1.54 times as likely to reach remission at week 8 than the participants treated with quetiapine extended release.3 “Over 32 weeks of follow-up, the percentage of patients with remission, the percentage of patients with a treatment response, and the change in the MADRS score from baseline favored esketamine nasal spray,” the investigators wrote. “The adverse events were consistent with the established safety profiles of the trial treatments.”2' Treatment-emergent adverse events were observed in 92% of participants treated with esketamine nasal spray and in 78% of participants treated with quetiapine extended release, and 4.2% of participants treated with esketamine nasal spray and 11% of patients treated with quetiapine extended release discontinued medication due to 1 or more adverse event(s).3 The results from ESCAPE-TRD were announced by Spravato (esketamine) developer Johnson & Johnson and published in The New England Journal of Medicine.4 The study published in The New England Journal of Medicine describes the full data gathered in ESCAPE-TRD for the first time.3 “This large head-to-head trial gives physicians important data to consider in the management of treatment-resistant depression by comparing the short- and long-term effectiveness of Spravato to an oral antipsychotic,” said Reina Benabou, MD, PhD, vice president of medical affairs, neuroscience, at Janssen Scientific Affairs, LLC, in a press release. “Spravato offers patients an additional important option. It is critical that those living with this difficult-to-treat condition have choices to consider for their personal treatment plans, in discussion with their health care providers.”3 Related Article: Study Compares Work Productivity Loss, Cost Savings in Esketamine Nasal Spray vs Quetiapine Extended-Release for TRD

Is psilocybin a viable treatment for MDD? Researchers performed a phase 2, double blind trial of single-dose psilocybin in patients with treatment resistant depression. Psilocybin is a hallucinogenic chemical in certain mushrooms known as magic mushrooms. Eating mushrooms that contain psilocybin can have a variety of effects, ranging from euphoria to hallucinations. CASE VIGNETTE “Mr Mora” is a 39-year-old African American male with a history of recurrent, severe major depressive disorder (MDD) without psychosis. The onset of his depression was in early adolescence. Mr Mora previously failed trials of sertraline, bupropion, venlafaxine, nortriptyline, lithium, aripiprazole, and perphenazine. He also sees a psychotherapist for monthly cognitive-behavioral therapy. His current regimen includes fluoxetine 80 mg daily and amphetamine-dextroamphetamine extended-release 20 mg daily, to which he has had a partial response. At his most recent outpatient clinic visit, Mr Mora asks whether he is a candidate for treatment with adjunctive psychedelics, and specifically asks about psilocybin. As his psychiatrist, how would you respond? Treatment-resistant depression (TRD) has been defined as failure of 2 different courses of treatment. Patients with TRD have greater duration of illness, illness severity, disability, physical illness, suicide risk, and economic costs than patients with treatment-responsive depression. Psilocybin has demonstrated antidepressant properties in patients with MDD and TRD.1-3 The Current Study Goodwin and colleagues4 conducted a phase 2 double-blind, dose-finding, parallel group, randomized controlled trial. The study sponsor, COMPASS Pathfinder, designed and funded the trial and provided a proprietary pharmaceutical-grade synthetic form of psilocybin (COMP360). An independent contract research organization (MedAvante-ProPhase) was responsible for assessment of participants using the Montgomery-Åsberg Rating Scale (MADRS), performed by trained, blinded, remote raters, as well as the statistical analyses. The sponsor performed data interpretation and post-hoc statistical analyses and paid for professional writing assistance for the first draft of the manuscript. The authors recruited adults aged 18 years or older with TRD, defined as a depressive episode without psychotic features, with failure to respond to an adequate dose and duration (≥ 8 weeks) of 2 to 4 pharmacological treatments for the current episode. The trial was conducted at 22 sites in Europe and North America between March 2019 and September 2021. Eligible participants completed a 3- to 6-week run-in period, during which antidepressants and medications affecting the central nervous system (CNS) were tapered and discontinued at least 2 weeks before the baseline visit. During this period, the participants met at least 3 times with a study therapist. Patients were randomized 1:1:1 to a single dose of psilocybin 25 mg, 10 mg, or 1 mg (control). The administration session lasted 6 to 8 hours and was accompanied by a lead therapist. Blood pressure was continuously monitored. Participants wore eyeshades and headphones with a specifically designed music playlist. The trial followed participants for 12 weeks after treatment, including 2 post-treatment integration sessions. The primary efficacy endpoint was the change in MADRS from baseline (day -1) to week 3 in the 25 mg- and 10 mg-dose groups compared to the 1-mg dose. Secondary endpoints were the proportion of responders (≥ 50% improvement in MADRS total score) and remitters (MADRS total score ≤ 10) at week 3, and sustained response (week 3 response maintained through week 12). Safety assessments included evaluation of adverse events, the Columbia Suicide Severity Rating Scale, vitals signs, clinical laboratory tests, and electrocardiogram (ECG). The authors calculated that a sample of 216 participants (72/group) would have 90% power to detect a 6-point difference in the mean change in the MADRS total score from baseline to week 3. Efficacy analyses were performed in the modified intention-to-treat analysis set. The primary efficacy endpoint (change in MADRS total score) was evaluated using mixed model for repeated measures analysis. Response and remission were analyzed using generalized linear mixed models, and sustained response was analyzed using binary logistic regression. A total of 428 participants were screened, and 233 were randomized and received psilocybin treatment (79 25-mg, 75 10-mg, 79 1-mg). The mean participant age was 40 years, 52% of participants were female, and 92% were white. Two-thirds of participants were receiving antidepressant treatment, and mean MADRS scores were 32 to 33 at baseline. The least-squares mean change from baseline to week 3 in the MADRS total score was -12.0 in the 25-mg group, -7.9 in the 10-mg group, and -5.4 in the 1-mg group. This change was statistically significant for the 25- versus 1-mg, but not the 10- versus 1-mg groups. The incidence of response was 37% in the 25-mg group, 19% in the 10-mg group, and 18% in the 1-mg group, corresponding to a 2.9-fold increased odds of response in the 25- versus 1-mg groups. The incidence of remission was 29% in the 25-mg group, 9% in the 10-mg group, and 8% in the 1-mg group, corresponding to a 4.8-fold increased odds of response in the 25- versus 1-mg groups. The incidence of sustained remission was 20% in the 25-mg group, 5% in the 10-mg group, and 10% in the 1-mg group, which was not statistically significant between groups. Adverse events occurred in 84% in the 25-mg group, 75% in the 10-mg group, and 72% in the 1-mg group, which was not statistically significant between groups. The most frequent adverse events on the day of administration were headache, nausea, dizziness, and fatigue. Serious adverse events from day 2 to week 3 in the 25- and 10-mg groups included suicidal ideation (n=4), non-suicidal self-injurious behaviors (n=3), and hospitalization for depression (n=1). There were no serious adverse events in the 1-mg group during this period. There were no clinically significant changes in vital signs, clinical laboratory tests, or ECG. Study Conclusions The authors concluded that the trial showed the feasibility of psilocybin monotherapy for up to 12 weeks in patients with TRD. The change from baseline to week 3 in MADRS total score was significantly better with 25-mg, but not 10-mg, versus the 1-mg dose. Reported adverse effects included headache, nausea, dizziness, and fatigue, as well as numerically higher suicidal ideation and self-injurious behavior in the 25- and 10-mg groups. Study limitations include the lack of an active comparator, the lack of an ethnically diverse participant sample, and the exclusion of participants at clinically significant risk for suicide. The intensity of the acute subjective effects of 25- and 10-mg psilocybin may have reduced the effective of trial blinding, although the ability of participants to guess their dose assignment was not assessed. The Bottom Line A single dose of 25 mg versus 1 mg psilocybin significantly reduced depression scores over 3 weeks in patients with TRD. Larger and longer trials, including comparisons with existing treatments, are required to determine the efficacy and safety of psilocybin in this patient population. Dr Miller is a professor in the Department of Psychiatry and Health Behavior at Augusta University in Georgia. He is on the Editorial Board and serves as the schizophrenia section chief for Psychiatric Times®. The author reports that he receives research support from Augusta University, the National Institute of Mental Health, and the Stanley Medical Research Institute. Related Articles: Single Psilocybin Dose Again Shows Major Depression Benefit Psilocybin Reduces Symptoms, Disability in Major Depression Psilocybin Plus SSRIs for Treatment-Resistant Major Depression