Clinical TrialMajor Depressive Disorder (MDD)DMTCompleted

Safety, Tolerability and Antidepressant Effects of DMT in Patients With Depression

Open-label Phase II single-group study (n=14) assessing ascending inhaled DMT (15 mg then 60 mg on a single day) for patients with partial response in depression.

Target Enrollment
14 participants
Study Type
Phase II interventional
Design
Non-randomized

Detailed Description

This phase II, open-label, single-group fixed-order study evaluates feasibility, safety and antidepressant effects of inhaled N,N‑Dimethyltryptamine (DMT) in patients with partial response to depression treatment.

Participants receive up to two inhaled DMT doses in one day (15 mg then 60 mg, ~1 hour apart) delivered via a vapour device; outcomes include acute and subacute mood measures and safety assessments with cardiovascular and respiratory exclusions applied.

Study Protocol

Preparation

sessions

Dosing

1 sessions

Integration

sessions

Study Arms & Interventions

DMT inhalation

experimental

Ascending fixed-order inhaled DMT administered using a vaporiser: 15 mg then 60 mg separated by ~1 hour within a single day.

Interventions

  • DMT15 - 60 mg
    via Inhalation• single day• 2 doses total

    Vapour device; fixed-order 15 mg then 60 mg with ~1-hour interval.

Participants

Ages
18 – 60
Sexes
Male & Female

Inclusion Criteria

  • Patients in current treatment for depression with a partial response.

Exclusion Criteria

  • heart failure
  • liver failure
  • kidney failure
  • uncontrolled high blood pressure
  • history of heart rhythm disorders
  • history of valvular heart disease
  • history of chronic obstructive pulmonary disease (COPD)
  • active or in treatment for bronchial asthma
  • severe obesity
  • coagulation disorders
  • clinical evidence or history of increased intracranial pressure
  • clinical evidence or history of cerebrospinal pressure
  • history or reports of epilepsy
  • severe neurological disease
  • pregnancy
  • reported or clinically recognized thyroid disorders
  • diagnosis or family suspicion of genetic monoamine deficiency oxidase
  • previous adverse response to psychedelic substances
  • symptoms or family members with a present or past psychotic disorder
  • dissociative identity disorder
  • bipolar affective disorder
  • prodromal symptoms of schizophrenia
  • problematic use or abuse of alcohol or other psychoactive substances (except tobacco)
  • acute or subacute risk of suicide
  • acute flu symptoms
  • symptoms of airway infection
  • contact with a confirmed case of COVID-19 (SARS-CoV-2) in the last 7 days

Study Details

  • Status
    Completed
  • Phase
    Phase II
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment14 participants
  • Timeline
    Start: 2023-10-09
    End: 2024-03-30
  • Compound
    DMT
  • Topic
    Major Depressive Disorder (MDD)

Locations

Hospital Universitário Onofre Lopes — Natal, Rio Grande do Norte, Brazil

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