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JAMA Psychiatry

ISSN 2168-622x; 2168-6238;

34 papers in the library · 5,657 citations · publishing 2013-2026

Papers

Blinding Integrity in Psychedelic Randomized Clinical Trials

JAMA Psychiatry April 15, 2026 Diana Orsini, Sabrina Wong, Sara Di Luch et al. 4 citations

In randomized clinical trials of psychedelic drugs for psychiatric disorders, the drugs' strong subjective effects often reveal which treatment participants or raters think they received, a phenomenon called functional unblinding. A systematic review of 112 trials found that only 29.5% assessed whether blinding was maintained, yet 57.1% cited blinding as a limitation. Blinding failure exceeded 90% in psilocybin, LSD, and ayahuasca studies and 85% in MDMA trials with inert placebos. Ketamine trials rarely assessed blinding but fared better when midazolam was used as an active comparator. No control strategy consistently preserved ideal blinding, raising concerns about the validity of efficacy estimates.

GH001 vs Placebo in Patients With Treatment-Resistant Depression

JAMA Psychiatry March 25, 2026 Wiesław Jerzy Cubała, Malek Bajbouj, Michael Bauer et al. 3 citations

A single day of treatment with an inhaled synthetic formulation of mebufotenin (GH001) significantly reduced depression symptoms in adults with treatment-resistant depression compared to placebo. In a randomized, double-blind trial of 81 patients, those receiving up to three escalating doses of GH001 showed an average 15.5-point greater improvement on the Montgomery-Åsberg Depression Rating Scale by day 8 than those on placebo. Remission rates were 57.5% for GH001 and 0% for placebo. No severe or serious adverse events occurred. The findings suggest GH001 may be a rapid-acting, well-tolerated treatment option for treatment-resistant depression.

Treating Bipolar Depression Using Psilocybin—Validity Threats Regarding Efficacy and Safety

JAMA Psychiatry April 10, 2024 Eiko I. Fried, Ioana A. Cristea, Florian Naudet 2 citations

A letter to the editor raises three concerns about a published study that tested 25 mg of psilocybin in 15 patients with treatment-resistant type 2 bipolar depression. The authors of the letter identify specific methodological issues with the study protocol but do not present new data or findings.

Ketamine for Depression—Knowns, Unknowns, Possibilities, Barriers, and Opportunities

JAMA Psychiatry December 1, 2023 Chittaranjan Andrade

Ketamine, an anesthetic with a history of recreational use, is being investigated for new on- and off-label indications across medical disciplines, including treatment-resistant depression, chronic pain, and other conditions. The article discusses the expanding experimental and clinical applications of ketamine, highlighting its potential benefits and risks as research progresses.