Antidepressant Effects of Ayahuasca: a Randomized Placebo Controlled Trial in Treatment Resistant Depression

• Status: Completed
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the present trial is to test the efficacy of Ayahuasca in treatment-resistant depression. Ayahuasca is a decoction of two plants, long used by Amazonian Amerindians. Traditionally, it is prepared by decoction of a bush (Psychotria viridis) with a liana (Banisteriopsis caapi). P. viridis is a rich source of N,N-dimethyltryptamine (DMT), a serotonergic agonist, and B. caapi contains potent monoamine oxidase-A inhibitors (MAOi-A), such as harmine, harmaline. The study is designed as a randomized placebo controlled trial with two parallel arms, and it will also evaluate changes of different biomarkers of depression including anatomical and functional Magnetic Resonance Imaging (MRI), serum levels of BDNF, TNF-a, cortisol, IL-6, and IL-10, polysomnography, neuropsychological, psychiatric scales and questionnaires.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Universidade Federal do Rio Grande do Norte
• Collaborator: University of Sao Paulo
• Treatments: Antidepressive Agents

Criteria

Inclusion Criteria:

• Age: 18-60 years old;

• Diagnostic of major depressive disorder (DSM-IV);

• At least two previous unsuccessful antidepressant medications;

• Current depressive episode (HAM-D >= 17).

Exclusion Criteria:

• History of psychosis;

• Present or past history of bipolar disorder or schizophrenia;

• Diagnosis of current clinical disease, based on history, physical examination and routine hematologic and biochemical tests;

• Serious and imminent suicidal risk;

• Pregnancy, current drug or alcohol dependence;

• Previous experience with ayahuasca.