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.
Country Brazil
Visit trial
Status
Completed
Results Published
Yes
Start date
01 February 2014
End date
01 December 2016
Chance of happening
100%
Phase
Phase I
Phase II
Design
Blinded
Type
Interventional
Generation
First
Participants
35
Sex
All
Age
18- 60
Therapy
No
Trial Details
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.NCT Number NCT02914769
Sponsors & Collaborators
Universidade Federal do Rio Grande do NorteThis company doesn't have a full profile yet, it is linked to a clinical trial.
University of São Paulo
The University of São Paulo has been conducting research with psychedelics for many years, with a focus on ayahuasca given its traditional use in Brazil.
Papers
Longterm effects of ayahuasca in patients with recurrent depression: a 5-year qualitative follow-upThis qualitative follow-up study (n=8) interviewed patients 4-7 years after the intake of ayahuasca (123.2 mg DMT, 32.34mg Harmine) within the context of a previous open-label study; most patients reported that the experience was among the most important of their lives, but no long-term improvements in depression scores (MADRS) were found.
Antidepressant effects of a single dose of ayahuasca in patients with recurrent depression a SPECT study
This open-label study (n=17) found that a single dose of ayahuasca (100-200ml) had significant antidepressant effects up to 21 days later (MADRS-scale and others).
The Impact of Ayahuasca on Suicidality: Results From a Randomized Controlled Trial
This analysis of a double-blind, parallel-arm, randomized placebo-controlled trial (n=29) investigates the impact of ayahuasca on suicidality (SI) in individuals with treatment-resistant depression (TRD). It found that ayahuasca may show potential as a fast-acting and innovative intervention for SI but didn't find significant results (only a trend with a large effect size). This is the first study to investigate ayahuasca for SI.
Rapid antidepressant effects of the psychedelic ayahuasca in treatment-resistant depression: a randomized placebo-controlled trial
This randomized placebo-controlled trial investigated the antidepressant efficacy of ayahuasca (25.2mg/70kg DMT, 130.2mg/70kg harmine, 16.8mg/70kg harmaline, 84mg/70kg tetrahydroharmine) in patients with depression. While both groups exhibited improvements in depression, between-group effect sizes increased throughout the week, yielding a significantly higher response rate in the ayahuasca group after a week.
Measures Used
Hamilton Depression Rating ScaleThe Hamilton Depression Rating Scale (HDRS) is a multiple item questionnaire used to provide an indication of depression, and as a guide to evaluating recovery. The scale consists of 17 items which each item being scoring on a 3 or 5 point scale. The higher the score, the more likely a person is depressed.
Montgomery-Asberg Depression Rating Scale
A ten-item diagnostic questionnaire used to measure the severity of depressive symptoms in patients with mood disorders.