NCT06094907CompletedPhase 2
Safety, Tolerability and Antidepressant Effects of DMT in Patients With Depression
An Open Label Trial of Inhaled N,N-Dimethyltryptamine in Patients With Partial Response in Depression.
Source: ClinicalTrials.gov · Last updated 8 May 2024
Brief summary (registry, in English)
This study aims to evaluate the acute and subacute effects of an inhaled N, N-Dimethyltryptamine (DMT) in patients with partial response in depression.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 14 (actual)
- First submitted
- 10 Oct 2023
- Start date
- 9 Oct 2023
- Primary completion date
- 15 Jan 2024
- Lead sponsor
- Universidade Federal do Rio Grande do Norte
- Diseases
- Depression
- NCT number
- NCT06094907
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 14
- From 9 Oct 2023 to the primary completion date, 15 Jan 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- previous adverse response to psychedelic substances
Other illness
- heart failure
- liver failure
- kidney failure
- history of heart rhythm disorders
- history of valvular heart disease
- history of chronic obstructive pulmonary disease (COPD)
- coagulation disorders
- clinical evidence or history of increased intracranial
- clinical evidence or history of cerebrospinal pressure
- history or reports of epilepsy
- severe neurological disease
- reported or clinically recognized thyroid disorders
- symptoms or family members with a present or past psychotic disorder
- dissociative identity disorder
- bipolar affective disorder
- symptoms of airway infection
- contact with a confirmed case of COVID-19 (SARS-CoV-2) in the last 7 days
Other
- uncontrolled high blood pressure
- active or in treatment for bronchial asthma
- severe obesity
- pregnancy
- diagnosis or family suspicion of genetic monoamine deficiency oxidase
- 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
Who the study is looking for
- Patients in current treatment for depression with a partial response.
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitário Onofre Lopes Coordinator of this site? Confirm its status | Natal | Brazil | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.