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WASHINGTON (Reuters) -The U.S. Supreme Court on Thursday blocked OxyContin maker Purdue Pharma's bankruptcy settlement that would have shielded its wealthy Sackler family owners from lawsuits over their role in the nation's deadly opioid epidemic. The 5-4 decision reversed a lower court's ruling that had upheld the plan to give Purdue's owners immunity in exchange for paying up to $6 billion to settle thousands of lawsuits accusing the company of unlawful misleading marketing of OxyContin, a powerful pain medication introduced in 1996. The ruling represented a victory for President Joe Biden's administration, which had challenged the settlement as an abuse of bankruptcy protections meant for debtors in financial distress, not people like the Sacklers who have not filed for bankruptcy. Conservative Justice Neil Gorsuch wrote the ruling, which was joined by fellow conservative Justices Clarence Thomas, Samuel Alito and Amy Coney Barrett, as well as liberal Justice Ketanji Brown Jackson. "The Sacklers have not filed for bankruptcy and have not placed virtually all their assets on the table for distribution to creditors, yet they seek what essentially amounts to a discharge. They hope to win a judicial order releasing pending claims against them brought by opioid victims. They seek an injunction 'permanently and forever' foreclosing similar suits in the future," Gorsuch wrote. "And they seek all this without the consent of those affected." Purdue filed for Chapter 11 bankruptcy in 2019 to address its debts, nearly all of which stemmed from thousands of lawsuits alleging that OxyContin helped kickstart an opioid epidemic that has caused more than half a million U.S. overdose deaths over two decades. At issue in the case was whether U.S. bankruptcy law lets Purdue's restructuring include legal protections for the members of the Sackler family, who have not filed for personal bankruptcy. These so-called "non-debtor releases" originally arose in the context of asbestos litigation, but their use has been expanded by companies looking to use such protections as a bargaining chip. The Stamford, Connecticut-based company estimates that its bankruptcy settlement, approved by a U.S. bankruptcy judge in 2021, would provide $10 billion in value to its creditors, including state and local governments, individual victims of addiction, hospitals and others who have sued the company. The Biden administration and eight states challenged the settlement. All the states dropped their opposition after the Sacklers agreed to contribute more to the settlement fund, but the U.S. Trustee - the Justice Department's bankruptcy watchdog - and some individual opioid plaintiffs maintained their opposition. Purdue issued a statement expressing disappointment in the court's decision. "Today's ruling is heart-crushing because it invalidates a settlement supported by nearly all of our creditors - including states, local governments, personal injury victims, schools and hospitals - that would have delivered billions of dollars for victim compensation, opioid crisis abatement, and overdose rescue and addiction treatment medicines," it said. Justice Brett Kavanaugh wrote a dissenting opinion that was joined be fellow conservative Chief Justice John Roberts, and liberal Justices Sonia Sotomayor and Elena Kagan. "Today's decision is wrong on the law and devastating for more than 100,000 opioid victims and their families," Kavanaugh wrote. 'I'LL SEE THEM IN COURT' Several state attorneys general issued statements praising the ruling, with some saying that it would bring Purdue back to the negotiating table. "Purdue and the Sacklers must pay so we can save lives and help people live free of addiction," said Josh Stein, attorney general of North Carolina. "If they won't pay up, I'll see them in court." Purdue, in its statement, said the company "will immediately reach back out to the same creditors who have already proven they can unite to forge a settlement in the public interest." In a statement, members of the Sackler family said they "remain hopeful about reaching a resolution that provides substantial resources to help combat a complex public health crisis." A group comprising more than 60,000 people who have filed personal injury claims stemming from their exposure to Purdue opioid products had told the Supreme Court they support the settlement, including legal immunity for members of the Sackler family. In upholding the settlement in May 2023, the Manhattan-based 2nd U.S. Circuit of Appeals concluded that federal bankruptcy law permits legal protections for non-bankrupt parties like the Sacklers in extraordinary circumstances. It ruled that the legal claims against Purdue were inextricably linked to claims against its owners, and that allowing lawsuits to continue targeting the Sacklers would undermine Purdue's efforts to reach a bankruptcy settlement. The Supreme Court in August 2023 paused bankruptcy proceedings concerning Purdue and its affiliates when it agreed to take up the administration's appeal of the 2nd Circuit's ruling. Lawsuits against Purdue and Sackler family members accused them of fueling the opioid epidemic through deceptive marketing of its pain medication. The company pleaded guilty to misbranding and fraud charges related to its marketing of OxyContin in 2007 and 2020. Members of the Sackler family have denied wrongdoing but expressed regret that OxyContin "unexpectedly became part of an opioid crisis." Note: This article originally appeared on Medscape .

Extended-release injectable naltrexone combined with extended-release oral bupropion (NTX + BUPN) for moderate or severe methamphetamine use disorder was associated with a significant decrease in use of the drug, a new study showed. Investigators leading the randomized clinical trial found a 27% increase in negative methamphetamine urine tests in the treatment group — indicating reduced use — compared with an 11% increase in negative urine tests in control participants. "These findings have important implications for pharmacological treatment for methamphetamine use disorder. There is no FDA-approved medication for it, yet methamphetamine-involved overdoses have greatly increased over the past decade," lead author Michael Li, MD, assistant professor-in-residence of family medicine at the David Geffen School of Medicine at UCLA, Los Angeles, said in a news release. The study was published online on June 10 in Addiction . Methamphetamine use has increased worldwide, from 33 million users in 2010 to 34 million in 2020, with overdose deaths rising fivefold in the United States over the past decade, the authors wrote. A previous open-label study of NTX + BUPN showed efficacy for treating severe methamphetamine use disorder, and NTX and BUPN have each shown efficacy separately for this indication. This new study is the second phase of the multicenter ADAPT-2 trial, conducted between 2017 and 2019 in 403 participants with methamphetamine use disorder. In the first stage, 109 people received NTX + BUPN and 294 received placebo. The treatment group received extended-release NTX (380 mg) or placebo as an intramuscular injection on weeks 1, 4, 7 and 10. Extended-release BUPN or placebo tablets were administered weekly, with BUPN doses starting at 150 mg on day 1 and increasing to 450 mg by day 3. At week 13, participants received a tapering dose for 4 days before discontinuing. As previously reported by Medscape Medical News , the two-drug combo was effective at reducing methamphetamine use at 6 weeks. The current analysis measured change in methamphetamine use during weeks 7-12 of the trial and in posttreatment weeks 13-16. Participants in the intervention group during stage 1 showed an additional 9.2% increase (P = .038) during stage 2 in their probability of testing negative for methamphetamine. This represented a total increase of 27.1% in negative urine tests across the complete 12 weeks of treatment, compared with a total 11.4% increase in negative tests in the placebo group. The 12-week increase in methamphetamine-negative urine tests in the intervention group was 15.8% greater (P = .006) than the increase in the placebo group. There was no significant change in either group at posttreatment follow-up in weeks 13-16. "Our findings suggest that ongoing NTX + BUPN treatment yields statistically significant reductions in methamphetamine-use that continue from weeks 7 to 12," the authors wrote. The lack of change in methamphetamine use from weeks 13-16 corresponds to the conclusion of treatment in week 12, they added. It "remains to be determined "whether continued use of NTX + BUPN treatment past 12 weeks would yield further reductions in use," the authors wrote, noting that prior stimulant use disorder trials suggest that change in use is gradual and that sustained abstinence is unlikely in merely 12 weeks of a trial. Rather, it is dependent on treatment duration. "This warrants future clinical trials to quantify changes in methamphetamine use beyond 12 weeks and to identify the optimal duration of treatment with this medication," they concluded. The study was funded by awards from the National Institute on Drug Abuse (NIDA), the US Department of Health and Human Services; the National Institute of Mental Health, and the O'Donnell Clinical Neuroscience Scholar Award from the University of Texas, Southwestern Medical Center. Alkermes provided Vivitrol (naltrexone for extended-release injectable suspension) and matched placebo free of charge for use in this trial under a written agreement with NIDA. Li reports no relevant financial relationships. The other authors' disclosures are listed on the original paper. Note: This article originally appeared on Medscape .

TOPLINE: Rates of cardiorespiratory depression are not significantly different between patients with severe agitation treated with olanzapine alone and those receiving a combination of olanzapine and a benzodiazepine. METHODOLOGY: Researchers assessed 693 patients with severe agitation in an emergency department who received intramuscular or intravenous olanzapine coadministered with either a second parenteral dose of olanzapine (n = 549) or a benzodiazepine (n = 144) within 60 minutes of each other between January 2017 and May 2019. The primary outcome was tracheal intubation. The secondary outcomes included hypoxemia (oxygen saturation less than 90%), hypotension (systolic blood pressure less than 90 mmHg), and death during hospitalization. TAKEAWAY: No significant difference in tracheal intubation rates was found between the olanzapine-only group and the olanzapine plus benzodiazepine group (3.8% vs 3.5%; difference, 0.3%; 95% CI, −3.0% to 3.7%). Respiratory depression was the reason for tracheal intubation in 10 out of 21 patients in the olanzapine-only group and 4 out of 5 patients in the olanzapine plus benzodiazepine group. The occurrence rate of hypotension was 9% in both groups. Among patients with a detectable alcohol concentration, 3.6% were intubated following two doses of olanzapine, and 6.4% received olanzapine plus a benzodiazepine. IN PRACTICE: "Our data suggest that if olanzapine monotherapy is not effective in this instance, rescue therapy with parenteral benzodiazepines is safe even if coadministered within 60 minutes," wrote the authors of the study. Note: This article originally appeared on Medscape .

PSYCHIATRIC VIEWS ON THE DAILY NEWS In yesterday’s column, I mentioned feeling dazed and confused after the Presidential debate. Other colleagues have expressed some similar reactions: “a physical gut punch,” “devastatingly unbelievable,” “the stuff of nightmares” from one side, with more positive emotional reactions from the other side. Thankfully, Al Simon, a new friend, came to my rescue. A week or 2 before, he strongly recommended I see “Inside Out 2,” thinking I would be interested in it as a psychiatrist and that he would like to know my reaction. One thing led to another, and we went yesterday with our spouses. I had seen the original “Inside Out” when it came out, just about 9 years ago. In that Pixar animated film, a 9-year-old girl named Riley moves with her parents from Minnesota to San Francisco. Her core emotions become characters inside her animated head in the movie, a place called Headquarters: Joy, Sadness, Anger, Fear, and Disgust. It was a creative, insightful, empathic, and compassionate portrayal of how our emotions influence our relationships. The title had also been intriguing to me because some years before that I had written a rare poem about being inside and outside our mind, a haiku. I think it was published in the Houston Psychiatric Society newsletter. I did clearly recall the lines: A psychiatrist Tries to transform the inside Outside of our selves The sequel, which also depicts changes in neurons and memories by rising lines and marbles (maybe as in “losing our marbles” mentally), has been an attendance bonanza. I would say that it is also a psychiatric success. Now Riley is 13, an age typically of increasing unhappiness as puberty roars in, but worsened in her case by having to start in a new high school separated from her 2 close friends. Keeping up with the times, these friends are of different cultures and the girls play a rough game of hockey. New emotional core characters are added as the old emotions are temporally put in mental storage. They are Anxiety, Ennui, Envy, Nostalgia, and Embarrassment. As she tries to impress the older students, Anxiety takes over from Joy and she becomes more selfish and not such a good person. She has to grieve the past losses to eventually move on. However, what I told my friend afterword, the emotion that seemed missing to me was Guilt. There is a dark place in her mind that seems to have some recollection of a bit of the trauma in her past, but it is a minor character. There is little explanation of how and why she took the turn to become a good person once again. There is no therapist handy. I am left wondering where the guilt is—or was—in our presidential debate and in many of our politicians. Perhaps in our society more broadly, guilt has been disappearing. We know that it is missing in sociopathy and undue narcissism. There are more parallels to real life. There is conflict that is worsening, not being resolved. Mental disorders are particularly escalating in teenagers, especially Black females. We are just starting to try to control cell phone overuse. Sometimes in the movie, like in life, things go by so fast that you feel you cannot put it together. That left me wanting to see it again and perhaps again. In that regard, it may also benefit from group discussion afterwards, like our 2 couples did during a meal. Although the target audience seems to be teenagers, their teachers, and their parents, it felt therapeutic to me. In that regard, it may be useful for patients, and perhaps they will want to discuss the movie with their therapist. Understanding our emotions and how much cognitive control we have over them is difficult. We elders may also get benefits from watching the movie. We, too, are helped by grieving what we have lost and are losing, including people and our usual climate. We particularly remember emotionally strong memories, good and bad, as we put our lives together. But memories for some are lost in dementias. Perhaps eventually, sequels will get to our age when we are losing neurons, but hopefully getting new connections of wisdom. Note: This article originally appeared on Psychiatric Times .

CLINICAL REFLECTIONS I began my career when the major treatments for schizophrenia were haloperidol and chlorpromazine. Since then, treatments for schizophrenia have improved slowly and incrementally, especially when looking back in the rearview mirror of what treatment used to be like. Although these improvements are appreciated by senior clinicians who have been around long enough to see these changes, most patients do not know (or care) about what happened way back when and are more concerned with limitations of currently available treatments. However, the slow pace of improvement may soon change. At the time of this writing, the US Food and Drug Administration (FDA) is reviewing a new treatment approach of a nondopaminergic muscarinic agonist that, if approved as soon as late 2024, could be the beginning of a period of disruptive changes in how schizophrenia is treated.1 However, the history of new treatments coming to schizophrenia should also serve as a warning. The underuse of clozapine followed by the underuse of newer long-acting injectables (LAIs) is a reminder that treatment advances can be undone by indifference, inadequate training and leadership, and lack of accountability that have plagued the treatment of individuals with serious mental illness. These kinds of service delivery problems make it much harder to unlock the potential benefits of better treatments. Therefore, this article will take a closer look at basic aspects of current treatment and make suggestions to get more out of our current and future medication options. It is common knowledge that high-quality treatment and availability of full range of services have remained out of reach for many patients with schizophrenia. Therefore, advances in drug development face headwinds when they become available into a treatment system that lacks the institutional infrastructure to adapt new treatments. Lack of training in currently available state-of-the-art pharmacologic and psychosocial treatments, lack of training in how to engage patients with severe mental illness, and gaps in continuity of care are leading examples of factors that derail the ability to execute a personalized treatment plan. To get the most from any treatment—let alone new ones—it will require not only prior approval of a new medication but also the ability to provide the treatment infrastructure to support these treatments. Here, we review 3 examples where additional focus or training is needed to get the most out of current and future pharmacologic treatments. Hierarchical treatment planning should be considered the default approach to long-term treatment planning for individuals with schizophrenia. As shown in the Figure,3 the basic idea of hierarchical treatment planning is to address problems in sequential order rather than trying to do everything at once or becoming overwhelmed with the sheer number of problems, which could lead to decision paralysis or seat-of-the-pants treatment decisions. A hierarchical approach makes sense for a complex illness like schizophrenia. Thinking 1 or 2 steps ahead of the current situation can be helpful when thinking about the treatment approach for patients experiencing acute symptoms. The base of the pyramid in the Figure visually depicts those patients who present to your service for the first time acutely ill or unstable. One of the advantages of making a hierarchical approach an automatic routine is that it requires thinking about what to do beyond the resolution of the acute episode. These postacute considerations also better lend themselves to patient-centered approaches than what is happening in the here and now of acute treatment. The middle rung of the Figure shows the transition after the patient is stabilized, and planning can begin ahead of time. If there is a transition of care, it often helps to involve the patient, family, or other clinicians in choosing the next set of priorities aimed at reducing the burden of illness or its treatment. Once stabilized, choose 1 target at a time. The specific target goal chosen will depend on priorities established by the patient and clinician and might include tackling a persistent symptom, eliminating a problematic adverse effect (AE), or improving physical health such as smoking cessation A.s before, the choice of intervention will consider the likelihood of success, the risk of any change, and the ordering of the burden of specific AEs that are most problematic. The basic idea is to categorize the problems and then review them individually while considering priorities. What is most important to the patient? The family? The treatment team? Next, consider the likelihood of success by looking at these goals from a perspective of likelihood of meaningful response to the considered treatment intervention with leaning toward goals where the intervention is more likely to succeed. Finally, consider the risks of the potential intervention(s)—not only the absolute medical risk but also the risk tolerance of the patient and other stakeholders. Another reason to use hierarchical treatment planning is to formalize the idea of sequential learning. It is likely that some interventions will succeed and others will fail. Focusing on 1 goal at a time makes it easier to use this knowledge to improve the likelihood of success later on. Here, patience is usually a virtue. Most interventions take time to evaluate before success or failure is known. Therefore, it is important to finish a sequential intervention because prematurely stopping before knowing the outcome will invalidate any useful information that might have been gained. It is hard to appreciate the value of information when things are not going well, so coaching the value of perseverance can be helpful. Why use a name like hierarchical treatment planning? The current American Psychiatric Association (APA) guideline is comprehensive but does not emphasize sequencing. Conveying a plan that includes working on patient-centered goals later shows a level of commitment, even if these goals cannot be part of the immediate plan. It can also help with continuity of treatment planning across different services or when there is a change in staffing within the same service. Focusing on one priority at a time can be useful in training and can empower the treatment team to look beyond the immediate challenges and work on future steps that align with available treatments and the patient’s priorities. In that way, hierarchical treatment planning fits well with another high priority: establishing and nurturing positive therapeutic relationships. 2. Making the Therapeutic Relationship Your Top Priority The default approach to treatment of schizophrenia is psychopharmacology. As discussed later, being skilled in psychopharmacology is essential, but the unintended consequence of emphasizing psychopharmacology has been a deprioritization of basic skills in how to communicate and collaborate with individuals who have psychotic symptoms. In clinical conferences, presentations emphasize pharmacologic treatments without having sessions on the advances in language and communication that are quite relevant to the relationship. There are many challenges working with schizophrenia that make the connection harder to achieve, including the lack of emotional connectedness that are part of negative symptoms, the off-putting nature of someone with a perseverative delusion, or deescalating a patient whose agitation is worsened by overstimulation in an emergency department (ED). The deemphasis on learning and practicing basic skills in therapeutic relationships is shortsighted. In fact, exclusively focusing on psychopharmacology while ignoring these skills will defeat the goal of psychopharmacology, assuming that goal is better outcomes. Studies show that patient engagement is one of the biggest predictors of outcome, including outcomes in medication studies (Table 16-10). However, it seems that the emphasis on how to make such an alliance or keep it going over time is something of a lost art. But this skill should not be optional; it should be embedded in the professional identity of those treating schizophrenia. Table 16-10 covers 10 aspects of interviewing, such as techniques and alliance building that help form or maintain an alliance with the patient. Although this list is not definitive, it is a start. Focusing your efforts on the therapeutic relationship will help you remain on task. These efforts are often rewarded with better quality information coming from a less-defensive patient. 3. Embracing Expertise in Pharmacologic Management The previous section discussed the problems of single-minded pursuit of psychopharmacology at the expense of other skills crucial to the therapeutic relationship, but there is another side to this problem: how often there are suboptimal outcomes to pharmacologic therapies. Despite significant advances in our understanding of the neuropharmacology of antipsychotics in the treatment of schizophrenia over the past 30 years, a large gap exists between what we now know and actual clinical practices. Table 2 provides 10 management issues that deviate from important evidence-based information that is the standard of care today.11-18 The list is categorized by issues that are remnants from the past use of neuroleptics (first-generation antipsychotics), the present lack of awareness and/or implementation of the current evidence-based standards, and it looks to the future. Unfortunately, there has been a tendency to underuse the few therapeutic modalities that are known to make a difference, namely LAI antipsychotics and clozapine. These interventions do require training and take time to implement. The point here is that we have good evidence that clinicians have been slow to adapt to more effective treatments, and this is likely the tip of the iceberg. The acceptability to many clinicians of certain AEs is an example of complacency and continued status quo mentality. A more serious example of ignoring changes in treatments is the continued widespread use of short-acting intramuscular (IM) haloperidol in EDs without knowing the patient’s history. Thirty years ago, the risks of IM haloperidol may have been acceptable because alternatives were not available. With today’s antipsychotic armamentarium, the risk is now much greater because other formulations do not have the same life-threatening risks of neuroleptic malignant syndrome, malignant hyperthermia, or laryngeal dystonia. The routine use of IM haloperidol for all patients with acute psychosis reflects a lost opportunity for better patient-centered outcomes. Another example is the complacency in treating tardive dyskinesia (TD), passively accepting the status quo of underuse of clozapine or LAIs because of the extra time and effort needed to learn and implement these treatment options. Although this is a topic in its own right, that is not the main point here. The main point is asking questions like: “Why is our profession so accepting of clinicians who do not learn or adapt to better treatments?” The aim of this section is to suggest that the sum is greater than the individual problems. There are too many lost opportunities in offering best practices to think of them as one-off problems. In my opinion, a better explanation is that the passivity and acceptance of outdated pharmacologic principles reflects problems in training, along with complacency and reluctance to try for better outcomes. To me, this goes beyond the individual clinician and can be traced to social factors such as relative neglect of the needs of schizophrenia and related disorders, and inadequate funding across the board for quality care, training, and reimbursement. Continuing this status quo of psychopharmacology that is “good enough to get by” will threaten the new opportunities for better outcomes as other treatments become available. Concluding Thoughts The past 70 years have focused on dopamine D2 receptor blockade as the center of pharmacologic treatments. Although useful, it has had the unintended effect of holding back progress for other treatment approaches. The dopamine monopoly has made it more difficult for the field to truly let go of believing that dopamine has just about everything and anything having to do with schizophrenia. The medication pipeline for the treatment of schizophrenia has more promise now than ever. At the time of this article, it seems that we are likely to have the first true nondopaminergic antipsychotic with the upcoming FDA review of the M1/M4 muscarinic agonist, xanomeline-trospium (KarXT). This muscarinic agonist will likely be the first of a series of medications and open a new era of treatments for schizophrenia. As new options become available, there will be a collective understanding of the role of new class(es) of medications and whether they will replace current medications as first-line treatments for schizophrenia. However, if the current status quo of complacency and low expectations stays unchanged, these advances may share the fate of clozapine and LAIs as representing important and life-changing medications that have remained underused and lost opportunities for better outcomes. Note: This article originally appeared on Psychiatric Times .

Eight commonly used antidepressants have been ranked by their weight gain potential. Results of a large observational study showed small differences in short- and long-term weight change in patients prescribed one of eight antidepressants, with bupropion associated with the lowest weight gain and escitalopram, paroxetine, and duloxetine associated with the greatest. Escitalopram, paroxetine, and duloxetine users were 10%-15% more likely to gain at least 5% of their baseline weight compared with those taking sertraline, which was used as a comparator. Investigators noted that the more clinicians and patients know about how a particular antidepressant may affect patients' weight, the better informed they can be about which antidepressants to prescribe. "Patients and their clinicians often have several options when starting an antidepressant for the first time. This study provides important real-world evidence regarding the amount of weight gain that should be expected after starting some of the most common antidepressants," lead author Joshua Petimar, ScD, assistant professor of population medicine in the Harvard Pilgrim Health Care Institute at Harvard Medical School, Boston, said in a press release. The findings were published online on July 1 in the Annals of Internal Medicine . Real-World Data Though weight gain is a commonly reported side effect of antidepressant use and may lead to medication nonadherence and worse outcomes, there is a lack of real-world data about weight change across specific medications. Investigators used electronic health records from eight healthcare systems across the United States spanning from 2010 to 2019. The analysis included information on 183,118 adults aged 20-80 years who were new users of one of eight common first-line antidepressants. Investigators measured their weight at baseline and at 6, 12, and 24 months after initiation to estimate intention-to-treat (ITT) effects of weight change. At baseline, participants were randomly assigned to begin sertraline, citalopram, escitalopram, fluoxetine, paroxetine, bupropion, duloxetine, or venlafaxine. The most common antidepressants prescribed were sertraline, citalopram, and bupropion. Approximately 36% of participants had a diagnosis of depression, and 39% were diagnosed with anxiety. Among selective serotonin reuptake inhibitors (SSRIs), escitalopram and paroxetine were associated with the greatest 6-month weight gain, whereas bupropion was associated with the least weight gain across all analyses. Using sertraline as a comparator, 6-month weight change was lower for bupropion (difference, 0.22 kg) and higher for escitalopram (difference, 0.41 kg), duloxetine (difference, 0.34 kg), paroxetine (difference, 0.37 kg), and venlafaxine (difference, 0.17 kg). Escitalopram, paroxetine, and duloxetine users were 10%-15% more likely to gain at least 5% of their baseline weight compared with sertraline users. Investigators noted little difference in adherence levels between medications during the study except at 6 months, when it was higher for those who took bupropion (41%) than for those taking other antidepressants (28%-36%). The study included data only on prescriptions and investigators could not verify whether the medications were dispensed or taken as prescribed. Other limitations included missing weight information because most patients did not encounter the health system at exactly 6, 12, and 24 months, only 15%-30% had weight measurements in those months. Finally, the low adherence rates made it difficult to attribute relative weight change at the 12- and 24-month time points to the specific medications of interest. "Clinicians and patients could consider these differences when making decisions about specific antidepressants, especially given the complex relationships of obesity and depression with health, quality of life, and stigma," the authors wrote. Note: This article originally appeared on Medscape .

The US Food and Drug Administration (FDA) has approved Eli Lilly's anti-amyloid donanemab (Kisunla) 350 mg/20 mL once-monthly injection for intravenous infusion for adults with early symptomatic Alzheimer's disease (AD), which includes mild cognitive impairment (MCI) or mild dementia stage of disease with confirmed amyloid pathology. Once-monthly donanemab is "the first and only amyloid plaque-targeting therapy with evidence to support stopping therapy when amyloid plaques are removed, which can result in lower treatment costs and fewer infusions," Eli Lilly said in a statement announcing approval. "This is real progress. Today's approval allows people more options and greater opportunity to have more time," said Joanne Pike, DrPH, Alzheimer's Association president and CEO. "Having multiple treatment options is the kind of advancement we've all been waiting for — all of us who have been touched, even blindsided, by this difficult and devastating disease," Pike said. As previously reported by Medscape Medical News , the FDA approval follows last month's unanimous thumbs up by an 11-member FDA advisory panel, which concluded that the anti-amyloid agent is effective for the treatment of patients with MCI or mild dementia and that the potential benefits outweigh the risks in this patient population. Approval was based on positive data from the phase 3 TRAILBLAZER-ALZ 2 trial, which showed that donanemab significantly reduced brain amyloid plaque burden and significantly slowed cognitive and functional decline compared with placebo in early symptomatic AD. "This approval marks another step forward in evolving the standard of care for people living with Alzheimer's disease that will ultimately include an arsenal of novel treatments, providing much needed hope to the Alzheimer's community," Howard Fillit, MD, co-founder and chief science officer at the Alzheimer's Drug Discovery Foundation (ADDF), said in the Eli Lilly statement. "As a physician, I am encouraged by the potential to stop treatment, which could reduce out-of-pocket costs and infusion burden for eligible patients," Fillit commented. Participants in the TRAILBLAZER-ALZ 2 study were able to complete treatment and switch to placebo at 6, 12, or 18 months after they achieved minimal levels of amyloid plaque consistent with a visually negative amyloid PET. In the overall population of patients receiving donanemab, 17% completed treatment at 6 months, 47% at 12 months, and 69% at 18 months on the basis of an assessment of amyloid levels via an amyloid PET. The FDA's dosing instructions state that prescribers can consider stopping the drug based on removal of amyloid plaques to minimal levels as observed on amyloid PET imaging. According to Eli Lilly, the price of each vial of donanemab is $695 before insurance. A 6-month course of treatment would cost $12,522; a 12-month course, $32,000; and an 18-month course, $48,696. Patients' out-of-pocket cost for donanemab will depend on their length of treatment and their insurance. Like other anti-amyloid agents, donanemab carries the risk for amyloid-related imaging abnormalities (ARIAs). The general consensus from the FDA advisory panel was that donanemab showed "convincing" efficacy with "acceptable and manageable" risks, including the risk for ARIAs, said Committee Chairperson Thomas Montine, MD, PhD, with Stanford University in California. Note: This article originally appeared on Medscape .

Mental health care after trauma is critical, especially for people in racial and ethnic minority groups who are at higher risk for developing post-traumatic stress disorder (PTSD). PTSD can be impairing, leading to stress or fear in everyday situations that harms a person’s health and well-being. Finding effective PTSD care is challenging in general, but systemic disparities and limited access make it even harder for people from racial and ethnic minority groups. A new study funded by the National Institute of Mental Health marks a step toward reducing disparities in mental health care. It found that a collaborative care intervention delivered in real-world settings significantly reduced PTSD symptoms among patients from racial and ethnic minority backgrounds. How did the researchers treat PTSD symptoms? Collaborative care is a team-based, patient-centered approach to treating mental disorders in acute and primary care settings. Health care providers work as a team and with the patient to provide comprehensive care tailored to the patient’s needs and preferences. In a “stepped” method, providers systematically and flexibly adjust the level of care based on the patient's condition and response to treatment. While previous studies have shown that collaborative care can reduce PTSD symptoms, few studies have examined its ability to address the unique mental health needs and disparities experienced by racial and ethnic minority groups. This study, which had support from the NIH Common Fund’s Health Care Systems Research Collaboratory , is one of the first multisite studies to compare collaborative care among White and non-White trauma patients. What did the researchers do in this study? Douglas Zatzick, M.D. , senior investigator on the project, and Khadija Abu, B.A., lead author on the paper, collaborated with colleagues at the University of Washington School of Medicine’s Harborview Trauma Center. They analyzed data from a large clinical trial of stepped collaborative care conducted at 25 trauma centers across the United States. People who were 18 years and older, seeking care for an injury, and experiencing a high level of distress based on a validated PTSD measure were eligible to participate. All participants self-reported their race and ethnicity. More than half (350 patients) identified as Hispanic or non-White (Asian, American Indian, Black, Native Hawaiian or Alaskan, Pacific Islander, or another race), including those endorsing more than one race. The other 285 patients identified as non-Hispanic White. Patients were randomized to receive either enhanced usual care or stepped collaborative care. Enhanced usual care: Patients received care as usual at the trauma center, which included PTSD screenings, a baseline evaluation, and follow-up interviews. The enhanced aspect was that nurses were notified if a patient's PTSD score was above a specified threshold. Stepped collaborative care: The intervention consisted of enhanced usual care plus additional follow-up, including proactive care management, cognitive behavioral therapy, and medication. Care was tailored to each patient’s specific postinjury needs and treatment preferences. Patients who showed ongoing PTSD symptoms received stepped-up care in the form of medication adjustments, additional therapy, or both. Patients rated their PTSD symptoms at intake and 3, 6, and 12 months after their injury. They also completed measures of depression symptoms, alcohol use problems, and physical function at intake and at the three post-injury time points. For each racial and ethnic group, analyses compared scores between patients who received enhanced usual care versus the stepped collaborative care intervention. What did the researchers find in the study? Six months after their injury, Hispanic or non-White patients who received collaborative care reported significantly lower PTSD symptoms compared to those who received usual care (with no difference at 3- or 12-months post-injury). The researchers note that most post-injury care occurred within the first 6 months, possibly contributing to a lack of significant effects at 3 months and a drop off of effects at 12 months. In contrast, no significant group difference was found for non-Hispanic White patients. Those who received usual care or collaborative care showed a similar change in PTSD symptoms at all time points, indicating that the intervention was no more effective than usual care for White patents in this study. There was no change in self-reported depression symptoms , alcohol use problems, or physical function for either group, regardless of whether they received usual care or collaborative care. This suggests that the intervention specifically helps with PTSD but not with other common trauma-related symptoms. What do the findings mean? Findings from this large, randomized clinical trial support comprehensive care delivered by clinicians as effective for treating mental disorders, including PTSD. The study also suggests that this comprehensive form of care is beneficial for people from racial and ethnic minority backgrounds, who often face disparities in medical settings. Among the factors the researchers attribute to the intervention’s success for a diverse group of trauma survivors are its patient-centered focus, flexible nature tailored to individual needs, and emphasis on shared decision-making. This study is already having a real-world impact by informing trauma care guidelines in the United States. The researchers' longstanding work with this population has helped establish best practices for screening and treating mental health and substance use disorders among trauma survivors. Based on the results of this study, trauma centers are now implementing a screening and referral process for patients at high risk for mental disorders after injury as part of a new standard of care. The next step for the researchers is to test this new standard of care against the collaborative care intervention . This study was limited by collapsing racial and ethnic groups into two categories, possibly masking differences in treatment responses. Replicating the study with larger samples would allow for more nuanced comparisons to see for which groups the intervention works best. Additionally, many patients in the study had experienced prior traumatic events and been hospitalized for PTSD, which may have led to different results compared to other collaborative care studies. Researchers should continue to explore collaborative care with diverse patient groups across different health care settings and with other mental disorders to refine the intervention and help make mental health care more equitable and effective. Note: This article originally appeared on NIMH .

Individuals with anxiety have at least a twofold higher risk of developing Parkinson's disease (PD) than those without anxiety, new research suggested. Investigators drew on 10-year data from primary care registry to compare almost 110,000 patients who developed anxiety after the age of 50 years to close to 900,000 matched controls without anxiety. After adjusting for a variety of sociodemographic, lifestyle, psychiatric, and neurological factors, they found that the risk of developing PD was double in those with anxiety compared with controls. "Anxiety is known to be a feature of the early stages of Parkinson's disease, but prior to our study, the prospective risk of Parkinson's in those over the age of 50 with new-onset anxiety was unknown," colead author Juan Bazo Alvarez, a senior research fellow in the Division of Epidemiology and Health at University College London, London, England, said in a news release. The study was published published online on June 24, 2024, in the British Journal of General Practice . The presence of anxiety is increased in prodromal PD, but the prospective risk for PD in those aged ≥ 50 years with new-onset anxiety was largely unknown. Investigators analyzed data from a large UK primary care dataset that includes all people aged between 50 and 99 years who were registered with a participating practice from January 1, 2008, to December 31, 2018. They identified 109,435 people (35% men) with more than one anxiety record in the database but no previous record of anxiety for ≥ 1 year and 878,256 people (37% men) with no history of anxiety (control group). Features of PD such as sleep problems, depression, tremor, and impaired balance were then tracked from the point of the anxiety diagnosis until 1 year before the PD diagnosis. Among those with anxiety, 331 developed PD during the follow-up period, with a median time to diagnosis of 4.9 years after the first recorded episode of anxiety. The incidence of PD was 1.2 per 1000 person-years (95% CI, 0.92-1.13) in those with anxiety vs 0.49 (95% CI, 0.47-0.52) in those without anxiety. After adjustment for age, sex, social deprivation, lifestyle factors, severe mental illness, head trauma, and dementia, the risk for PD was double in those with anxiety compared with the non-anxiety group (hazard ratio, 2.1; 95% CI, 1.9-2.4). Individuals without anxiety also developed PD later than those with anxiety. The researchers identified specific symptoms that were associated with later development of PD in those with anxiety, including depression, sleep disturbance, fatigue, and cognitive impairment, among other symptoms. "The results suggest that there is a strong association between anxiety and diagnosis of PD in patients aged > 50 years who present with a new diagnosis of anxiety," the authors wrote. "This provides evidence for anxiety as a prodromal presentation of PD." Future research "should explore anxiety in relation to other prodromal symptoms and how this symptom complex is associated with the incidence of PD," researchers wrote. Doing so "may lead to earlier diagnosis and better management of PD," they added. This study was funded by the European Union. Specific authors received funding from the National Institute for Health and Care Research and the Alzheimer's Society Clinical Training Fellowship program. The authors declared no relevant financial relationships. Note: This article originally appeared on Medscape .

TOPLINE: Just one third of outpatient community mental health treatment facilities (MHTFs) in 20 states with the highest rates of opioid overdose report they offer medication for opioid use disorder (MOUD), new research showed. METHODOLOGY: Researchers surveyed administrators of 450 MHTFs in 20 states identified by high opioid overdose rates using a standardized 10-item survey. States included Arizona, California, Connecticut, and 17 others, focusing on publicly funded facilities. Researchers obtained data from the RAND Mental Health and Addiction Treatment Tracking Repository, which includes information about each MHTF. TAKEAWAY: About one third of facilities (34%) offered MOUD. Buprenorphine (84%) and naltrexone (70%) are the most frequently offered medications, while methadone (14%) is less commonly offered. Facilities with integrated treatment services are more likely to offer MOUD. A total of 70% of participants paid for MOUD with private insurance, 84% with Medicaid, 67% with Medicare, and 75% paid out of pocket. IN PRACTICE: "Outpatient community mental health treatment facilities can be an important part of the treatment ecosystem for individuals with opioid use disorders," lead author Jonathan Cantor, PhD, said in a press release. "Our findings suggest that offering integrated substance use disorder services for people with co-occurring mental illnesses is a potential avenue toward improving uptake of medication-assisted treatment among those with opioid use disorder." SOURCE: The study was led by Jonathan Cantor, PhD, of RAND in Santa Monica, California. It was published online on June 18 in JAMA Network Open . LIMITATIONS: The study's focus on states with high opioid overdose rates may limit generalizability. The extent to which facilities deliver MOUD and the number of patients receiving it remain unknown. DISCLOSURES: The study was supported by the Foundation for Opioid Response Efforts. Jonathan Cantor reported grants from the National Institute of Mental Health and the National Institute on Aging outside the submitted work. Additional disclosures are noted in the original article. Note: This article originally appeared on Medscape .

PSYCHIATRIC VIEWS ON THE DAILY NEWS Tonight is the first presidential debate for our upcoming elections. Usually, mental health gets short shrift in these debates, so here are some last-minute questions that I hope are asked. In contrast to the Goldwater Rule against any personal psychiatric analysis of public figures, asking about policies is fine. Given the worrisome rise of mental disturbances over at least the last decade, spanning both of your administrations, what would you now do to improve the mental health of our citizens? Do you think that climate instability is worsening our collective mental stability and, if so, in what ways? Has legalizing marijuana in some states been a benefit or mistake? Why or why not? Should psychedelics be legalized? Why or why not? How would you reduce the divisiveness between Democrats and Republicans? Since you both were President during the COVID-19 pandemic and now, although less severe, cases are rising again, what would you do differently if you were faced with a similar pandemic challenge once more? What do you think about physician-assisted suicide? How do you like our Surgeon General publicly coming out about our loneliness, social media harm, and gun control problems, and what would you do to address those problems? Do you think that your administration would be helped by having a psychiatrist consultant at a high level in your government? How would you assess your own mental health in your readiness for the stress and challenges of being President at your advanced ages, and would you agree to have an expert and objective mental health exam before the election? Perhaps we can use any attention—or none—in this debate about mental health to make recommendations for the next time around. What would you like to ask? Note: This article originally appeared on Psychiatric Times .

I read this quote every morning and it helps me feel process life and it's moments of vulnerability. Live the Life you've always dreamed of. Be FEARLESS in the face of adversity. Never stop learning. Use your imagination whenever possible. Recognize the BEauty that surrounds YOU. Remember where you came from, but don't lose sight of where you are going. BE THE ARCHITECT of your destiny. This life is YOURS TO CREATE!