Focus (American Psychiatric Publishing)
July 1, 2023
Jennifer M Mitchell, Michael Bogenschutz, Alia Lilienstein et al.
97 citations
A phase 3 clinical trial tested MDMA-assisted therapy for severe PTSD. In 90 participants randomized to receive either MDMA or placebo alongside therapy, those receiving MDMA showed a significantly larger reduction in PTSD symptoms, with an average decrease of 24.4 points on the CAPS-5 scale compared to 13.9 points in the placebo group. Functional impairment also improved more with MDMA. No serious safety issues like abuse potential or suicidality were observed. The treatment was effective even for patients with common co-occurring conditions such as depression or substance use history. The authors conclude MDMA-assisted therapy is a safe and highly effective treatment for severe PTSD.
Focus (American Psychiatric Publishing)
July 1, 2023
Allison A Feduccia, Lisa Jerome, Berra Yazar-Klosinski et al.
24 citations
Two FDA-approved medications for PTSD, paroxetine and sertraline, show only small to moderate effects over placebo. Pooled analyses of Phase 2 studies indicate that MDMA-assisted psychotherapy—combining the drug with three monthly 8-hour therapy sessions plus preparatory and integrative sessions—produces a large effect size and lower dropout rates than the approved medications. The treatment also carries minimal risk of diversion, overdose, or withdrawal because MDMA is administered under direct observation. This review describes the data that earned MDMA-assisted psychotherapy Breakthrough Therapy Designation from the FDA, which has accelerated Phase 3 trials toward a planned 2021 submission for FDA approval.
Focus (American Psychiatric Publishing)
October 1, 2022
Jenna M Traynor, Daniel E Roberts, Stephen Ross et al.
14 citations
Borderline personality disorder is a complex psychiatric condition with limited and often ineffective treatment options, high variability in patient response, and frequent dropout from therapy. This review considers the potential of MDMA-assisted psychotherapy (MDMA-AP) as a new or complementary treatment. Based on MDMA-AP's promise in treating overlapping disorders like posttraumatic stress disorder, the authors propose initial treatment targets and hypothesized mechanisms of change grounded in prior literature and theory. They also outline considerations for designing clinical trials to investigate the safety, feasibility, and preliminary effects of MDMA-AP for borderline personality disorder.
Focus (American Psychiatric Publishing)
July 1, 2023
Lauren Lepow, Hirofumi Morishita, Rachel Yehuda
9 citations
Psychedelic-assisted psychotherapy may work by reopening a critical period of heightened neuroplasticity, similar to developmental windows when the brain is especially sensitive to environmental input. The paper proposes that psychedelics could remove molecular brakes on adult neuroplasticity, creating a brain state akin to neurodevelopment. Drawing on ocular dominance plasticity in the visual system as a model, the authors suggest this framework could help explain how combining psychedelic compounds with psychotherapy produces enduring clinical improvements in conditions like PTSD. The framework integrates neuroscientific inquiry with the influence of environment both in development and in therapy.
Focus (American Psychiatric Publishing)
October 1, 2023
Farhan Fancy, Nelson B Rodrigues, Joshua D Di Vincenzo et al.
4 citations
Repeated intravenous ketamine infusions significantly reduced depression, suicidal thoughts, and anxiety in patients with treatment-resistant bipolar I/II depression, and improved functioning. In an observational study of 66 patients receiving four infusions over two weeks, depressive symptoms dropped by an average of 6.08 points on the QIDS-SR16 scale. Response rate was 35% and remission rate 20%. Hypomania occurred in only 4.5% of patients, with no mania or psychosis. The findings suggest real-world effectiveness and tolerability of IV ketamine for bipolar depression.
Focus (American Psychiatric Publishing)
April 1, 2025
Sophie I Elliott, Rachel B Katz, Robert B Ostroff et al.
2 citations
For severe treatment-resistant depression, both electroconvulsive therapy (ECT) and ketamine are effective, but it remains unclear which is superior. Two noninferiority trials and three meta-analyses show efficacy for both treatments yet report contradictory findings about which works better. Discrepancies may stem from differences in patient selection, outcome measures, treatment delivery, and site experience. Each treatment has unique risks and benefits that should be weighed for individual patients. The authors aim to help clinicians choose the optimal treatment by evaluating the latest evidence and patient-specific factors.
Focus (American Psychiatric Publishing)
July 1, 2024
Claire J Foldi, Paul Liknaitzky, Martin Williams et al.
Anorexia nervosa has the highest death rate of any psychiatric illness, but current medications are largely ineffective partly because the neurobiological causes are poorly understood. Renewed research into psychedelic medicine, particularly psilocybin, suggests it may help symptoms related to serotonin signaling and cognitive inflexibility in anorexia nervosa. Clinical trials for treatment-resistant depression show promising results, though methodological biases remain. The first clinical trial of psilocybin in anorexia nervosa patients began in 2019, highlighting the need to understand the underlying neurobiological mechanisms. Animal models, such as the activity-based anorexia rodent model, can provide detailed brain and behavior analysis without the confounds of patient expectancy and bias. The authors argue such studies are crucial for informing clinical applications and identifying which patient subpopulations might benefit most.