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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02914769
Recruitment Status : Completed
First Posted : September 26, 2016
Last Update Posted : February 17, 2017
Sponsor:
Collaborator:
University of Sao Paulo
Information provided by (Responsible Party):
Draulio Barros de Araujo, Universidade Federal do Rio Grande do Norte

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Major Depression Drug: Ayahuasca Drug: placebo Phase 1 Phase 2

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Antidepressant Effects of Ayahuasca: a Randomized Placebo Controlled Trial in Treatment Resistant Depression
Study Start Date : February 2014
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

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Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: placebo
patients receiving a passive placebo
 Drug: placebo
patients will receive a single dose of a passive placebo.
Experimental: Ayahuasca
patients receiving Ayahuasca
 Drug: Ayahuasca
patients will receive a single dose of ayahuasca.


Outcome Measures
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Primary Outcome Measures :
  1. HAM-D effect at D7 [ Time Frame: seven days after dosing ]
    changes in depression severity, assessed by HAM-D scale, from baseline to 7 days after dosing


Secondary Outcome Measures :
  1. MADRS effect at D1, D2 and D7 [ Time Frame: one, two and seven days after dosing ]
    changes in depression severity, assessed by MADRS scale, from baseline to 1 day, 2 days, and 7 days after dosing

  2. Response rate at D7 (HAM-D) [ Time Frame: seven days after dosing ]
    response rate: reduction of 50% or more in baseline scores, assessed seven days after dosing by the HAM-D scale.

  3. Response rate at D1, D2 and D7 (MADRS) [ Time Frame: one, two, and seven days after dosing ]
    response rate: reduction of 50% or more in baseline scores, assessed at one day, two days and seven days after dosing by the MADRS scale.

  4. Remission rate at D7 (HAM-D) [ Time Frame: seven days after dosing ]
    remission rate: HAM-D≤7 at D7.

  5. Remission rate at D1, D2 and D7 (MADRS) [ Time Frame: one, two and seven days after dosing ]
    remission rate: MADRS≤10 at D1, D2 and D7


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02914769


Locations
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Brazil
Draulio B de Araujo
Natal, Rio Grande do Norte, Brazil, 59012-300
Sponsors and Collaborators
Universidade Federal do Rio Grande do Norte
University of Sao Paulo
Investigators
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Principal Investigator: Draulio B de Araujo, Ph.D Brain Institute - UFRN
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Draulio Barros de Araujo, Professor, Universidade Federal do Rio Grande do Norte
ClinicalTrials.gov Identifier: NCT02914769    
Other Study ID Numbers: CNPq-466760/2014-0
First Posted: September 26, 2016    Key Record Dates
Last Update Posted: February 17, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Draulio Barros de Araujo, Universidade Federal do Rio Grande do Norte:
Depression
Ayahuasca
Psychedelics
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Depressive Disorder, Treatment-Resistant
 Behavioral Symptoms
Mood Disorders
Mental Disorders