Status:
COMPLETED
Safety, Tolerability and Antidepressant Effects of DMT in Patients With Depression
Lead Sponsor:
Universidade Federal do Rio Grande do Norte
Conditions:
Depressive Disorder
Depression, Unipolar
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief Summary
This study aims to evaluate the acute and subacute effects of an inhaled N, N-Dimethyltryptamine (DMT) in patients with partial response in depression.
Detailed Description
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.
Eligibility Criteria
Inclusion
- Patients in current treatment for depression with a partial response.
Exclusion
- 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
Key Trial Info
Start Date :
October 9 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 30 2024
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT06094907
Start Date
October 9 2023
End Date
March 30 2024
Last Update
May 8 2024
Active Locations (1)
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1
Hospital Universitário Onofre Lopes
Natal, Rio Grande do Norte, Brazil, 59012300