This open-label Phase II trial (n=12) is designed to assess the acute and subacute effects of inhaled N,N-Dimethyltryptamine (DMT) in patients with partial response in depression. Led by the Universidade Federal do Rio Grande do Norte in Brazil, the study, titled started on October 9, 2023, and is estimated to conclude on March 30, 2024, with an estimated enrollment of 12 participants. The intervention involves administering up to 2 inhaled doses of DMT (15 mg, followed by 60 mg) within a single day, with a 1-hour dose interval.
The primary outcome measures include changes in Montgomery and Asberg Depression Rating Scale (MADRS) scores seven days after the dosing session. Secondary outcome measures encompass changes in Patient Health Questionnaire-9 (PHQ-9) scores, Beck rating scale for suicidal ideation (BSI) scores, and additional MADRS assessments at different time frames. The study also monitors physiological parameters, plasma levels of various biomarkers, and subjective effects of DMT.
Eligible participants are individuals aged 18 to 60 currently undergoing treatment for depression with a partial response. Exclusion criteria encompass various health conditions and substance use disorders. The trial is being conducted in Natal, RN, Brazil, at Hospital Universitário Onofre Lopes.
Trial Details
This is a phase II open-label, single-ascending, fixed-order study to assess the feasibility and efficacy of inhaled N, N-Dimethyltryptamine (DMT) in patients with partial response in depression.NCT Number NCT06094907
Sponsors & Collaborators
Universidade Federal do Rio Grande do NorteThis company doesn't have a full profile yet, it is linked to a clinical trial.