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FDA Raises Concerns About Flaws In Study Testing MDMA As PTSD Treatment
The New York Times (5/31, Jacobs , Jewett ) reported the FDA “on Friday raised concerns about the health effects of MDMA as a treatment for post-traumatic stress disorder, citing flaws in a company’s studies that could pose major obstacles to approval of a treatment anticipated to help people struggling with the condition.” FDA staff “said that bias had seeped into the studies because participants and therapists were readily able to figure out who got MDMA versus a placebo.” The agency “also flagged ‘significant increases’ in blood pressure and pulse rates that could ‘trigger cardiovascular events.’”
The AP (5/31, Perrone ) reported the FDA “posted its initial review of the drug Friday, ahead of a meeting of outside advisers who could help decide whether MDMA – currently illegal under federal law – becomes the first drug of its kind to win U.S. approval as a medication.” In the review, “FDA scientists said that patients who received MDMA and talk therapy showed ‘rapid, clinically meaningful, durable improvements in their PTSD symptoms.’” However, “they also called the research ‘challenging to interpret,’ and questioned how long the benefits might last.”
The Washington Post (5/31, Gilbert , Ovalle ) reported, “The agency’s review outlines the challenges for sponsor Lykos Therapeutics, which conducted two late-stage clinical trials showing that patients treated with MDMA – better known by its street name, ecstasy – experienced a significant improvement in their PTSD symptoms relative to those who got a placebo.”
Reuters (5/31, Jain, Roy) reported there “is a large unmet need for new treatments for PTSD, which affects those who have experienced traumatic events and is common among war veterans, as existing drugs do not work on all patients.”
Related Links:
— “The New York Times (requires login and subscription)
Preteens Whose Parents Are Incarcerated At Higher Risk Of Suicidal Ideation, Study Finds
Healio (5/31, Weldon) reported, “Preteens whose parents were incarcerated or arrested were more likely to experience suicidal ideation, according to research published in Pediatrics.” In the study, “researchers examined data from 10,532 children who participated in the ABCD study and found that 6.5%…reported parental incarceration and 12% reported parental arrest.” Of those, “4.7% reported suicidal ideation. The researchers calculated that children whose parents had been incarcerated had an RR of suicidal ideation of 1.74 (95% CI, 1.32-2.31). Children whose parents had been arrested had an RR of suicidal ideation of 1.89 (95% CI, 1.53-2.37) and an RR of suicide attempt of 2.69 (95% CI, 1.7-4.25).”
Related Links:
— “Parents’ incarceration may put kids at higher risk for suicidal thoughts,”Rose Weldon, Healio, May 31, 2024
Teen Cannabis Use Associated With Greater Risk For Development Of Psychotic Disorders, Study Finds
Healio [mailview.bulletinhealthcare.com] (5/30, Weldon) reports, “Teenagers who use cannabis have a much higher risk for developing a psychotic disorder compared with their nonusing peers, according to research published in Psychological Medicine.” In the study [mailview.bulletinhealthcare.com], “researchers found that, compared with no cannabis use, cannabis use was significantly associated with psychotic disorders during adolescence (adjusted HR = 11.2; 95% CI, 4.6-27.3), but not during young adulthood (aHR = 1.3; 95% CI, 0.6-2.6). When the researchers restricted outcomes to hospitalizations and ED visits, the strength of the association increased markedly during adolescence (aHR = 26.7; 95% CI, 7.7-92.8) but again did not change meaningfully during young adulthood (aHR = 1.8; 95% CI, 0.6-5.4).”
Related Links:
— “Study suggests strong link between teen cannabis use, psychotic disorders,”Rose Weldon, Healio, May 30, 2024
PTSD Diagnoses Among US College Students More Than Doubled Between 2017 And 2022, Study Finds
The New York Times [mailview.bulletinhealthcare.com] (5/30, Barry ) reports, “Post-traumatic stress disorder diagnoses among college students more than doubled between 2017 and 2022, climbing most sharply as the coronavirus pandemic shut down campuses and upended young adults’ lives, according to new research published on Thursday.” PTSD prevalence “rose to 7.5 percent from 3.4 percent during that period, according to the findings [mailview.bulletinhealthcare.com],” which were published in JAMA Network Open.
Related Links:
— “The New York Times (requires login and subscription)
“Psychiatric Ambulance” Provides Safe, Uncoercive Transport Of Individuals In Mental Health Crisis, Study Finds
Psychiatric News (5/29) reports, “Individuals having a mental health crisis who were transported to a hospital by a ‘psychiatric ambulance’ required fewer restraints or other coercive measures compared with individuals transported by the police, according to a report in Psychiatric Services.” This option is an alternative to law enforcement transporting patients, as police “usually receive limited training in managing psychiatric disorders and in responding to individuals experiencing psychiatric symptoms or crises, which may increase the risk for preventable escalation and the use of restrictive measures,” researchers wrote.
Related Links:
— “Study Finds ‘Psychiatric Ambulance’ Provides Safe and Uncoercive Transport of Individuals in Crisis, Psychiatric News , May 29, 2024
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