Inhaled DMT for Major Depressive Disorder

Sponsor
Universidade Federal do Rio Grande do Norte
Study ID
NCT07562191
Phase
PHASE2
Status
Recruiting
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Conditions

  • MDD
  • Major Depression
  • Major Depressive Disorder (MDD)
  • Suicidal Ideation
  • Suicide

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • N,N-Dimethyltryptamine (15 mg + 60 mg) — DRUG
    Inhaled N,N-dimethyltryptamine (DMT) administered via a Volcano Medic 2 vaporizer in two inhalations 1 hour apart, using a high-dose regimen (15 mg + 60 mg).
  • N,N-Dimethyltryptamine (1 mg + 4 mg) — DRUG
    Inhaled N,N-dimethyltryptamine (DMT) administered via a Volcano Medic 2 vaporizer in two inhalations 1 hour apart, using a low-dose regimen (1 mg + 4 mg).

Study Details

This Phase 2b, randomized, double-blind, active-controlled clinical trial will evaluate the efficacy and safety of inhaled N,N-dimethyltryptamine (DMT) in adults with Major Depressive Disorder (MDD). The study will test whether inhaled DMT can rapidly reduce depressive symptoms and suicide risk compared with a low-dose active comparator. A total of 140 participants will be randomized 1:1 to receive either 15 mg followed 1 hour later by 60 mg of inhaled DMT, or 1 mg followed 1 hour later by 4 mg of inhaled DMT. Participants who do not achieve remission at Day 7 will enter an open-label extension and receive a high-dose DMT session on Day 14 (±3 days). All participants will be followed for up to 12 months to evaluate the durability of response, safety, functioning, and quality of life.

Key Dates

First listed
May 1, 2026
Start date
Aug 1, 2026
Status verified
Jul 2026
Primary completion
Feb 1, 2027
Completion
Aug 1, 2027

Study Design

Enrollment
140 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: High-Dose DMT → Remitters (No Re-dosing)
    Participants randomized to the high-dose DMT group (15 mg followed by 60 mg on Day 0) who achieve remission at Day 7 (MADRS ≤10) receive no further dosing and enter long-term follow-up.
  • Experimental: High-Dose DMT → Non-Remitters (Open-Label Re-dosing)
    Participants randomized to the high-dose DMT group (15 mg followed by 60 mg on Day 0) who do not achieve remission at Day 7 (MADRS \>10) receive an additional open-label high-dose session (15 mg followed by 60 mg) on Day 14 (±3 days), followed by long-term follow-up.
  • Active Comparator: Low-Dose DMT → Remitters (No Re-dosing)
    Participants randomized to the low-dose DMT group (1 mg followed by 4 mg on Day 0) who achieve remission at Day 7 (MADRS ≤10) receive no further dosing and enter long-term follow-up.
  • Active Comparator: Low-Dose DMT → Non-Remitters (Open-Label Re-dosing)
    Participants randomized to the low-dose DMT group (1 mg followed by 4 mg on Day 0) who do not achieve remission at Day 7 (MADRS \>10) receive an open-label high-dose session (15 mg followed by 60 mg) on Day 14 (±3 days), followed by long-term follow-up.

Primary Outcome Measure

Change from Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score (Antidepressant efficacy) [ Time Frame: Baseline and Day 7 (D7) after the dosing session ]

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