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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-09

Study Completion Date

2024-03-30

Brief Summary

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This study aims to evaluate the acute and subacute effects of an inhaled N, N-Dimethyltryptamine (DMT) in patients with partial response in depression.

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Detailed Description

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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.

Conditions

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Depressive Disorder Depression, Unipolar

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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N,N-Dimethyltryptamine

Administration of up to 2 inhaled doses of DMT within a single day (15 mg, followed by 60 mg) with a 1-hour dose interval.

Group Type EXPERIMENTAL

N,N-Dimethyltryptamine

Intervention Type DRUG

DMT will be administered using a vaporizer device in an ascending fixed-order of 15mg and 60mg.

Interventions

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N,N-Dimethyltryptamine

DMT will be administered using a vaporizer device in an ascending fixed-order of 15mg and 60mg.

Intervention Type DRUG

Other Intervention Names

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DMT

Eligibility Criteria

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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
* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No