Characteristics of Ongoing Clinical Trials of Psychogenic Substances for Psychiatric Disorders
Abstract
BACKGROUND: With a rapid rise in clinical trials investigating psychogenic substances, the field faces considerable concerns regarding transparency and conflicts of interest. This study aims to systematically characterize ongoing NIH-registered clinical trials investigating psychogenic substances for psychiatric disorders as of late 2024, including research protocols, institutional settings, and funding sources.
PROCEDURES: This cross-sectional analysis evaluated ongoing trials from ClinicalTrials.gov that studied psychogenic substances-defined as compounds significantly affecting perception, cognition, or emotion-for psychiatric conditions. Data collected included substance class, targeted diagnoses, trial phase, geographic location, study design (eg, blinding), recruitment status, and funding sources.
FINDINGS: A total of 181 trials met the inclusion criteria, with the majority in phase 2 (n=93; 51.4%) or phase 1 (n=33; 18.2%). The most frequently studied substances were psilocybin (n=64; 35.4%) and ketamine (n=61; 33.7%). Trials were notably concentrated within a small number of leading academic institutions. Most trials (n=148; 81.2%) listed their funding source as "other," of which 127 (86.4%) were sponsored by universities or university-affiliated institutions. Blinding was not reported in 38.7% (n=70) of trials. The primary conditions studied were major depressive disorder (n=94; 51.9%), posttraumatic stress disorder (n=38; 21.0%), and alcohol use disorder (n=21;…
How strong is the evidence?
Evidence Hub reads this as a cross-sectional, done in people. Its evidence level is 4 of 5 (Low · observational). Observational designs can show an association but not prove cause. Reported size: 148 participants or records.
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