Clinical TrialTreatment-Resistant Depression (TRD)AyahuascaPlaceboCompleted

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

Randomized, placebo-controlled parallel trial (n=35) testing a single oral dose of ayahuasca versus placebo in patients with treatment-resistant major depression.

Target Enrollment
35 participants
Study Type
Phase I/II interventional
Design
Randomized, triple Blind

Detailed Description

This randomized, parallel-group trial evaluated the antidepressant effects of a single oral dose of ayahuasca compared with a passive placebo in patients with treatment-resistant major depression (n=35), with acute and longer-term follow-up.

Outcomes included depressive symptom scales (HAM-D, MADRS), psychiatric and neuropsychological assessments, MRI (structural and functional), polysomnography, and serum biomarkers (BDNF, TNF-α, cortisol, IL-6, IL-10).

Study Protocol

Preparation

sessions

Dosing

1 sessions
240 min each

Integration

sessions

Study Arms & Interventions

Ayahuasca

experimental

Single-dose ayahuasca treatment arm.

Interventions

  • Ayahuasca
    via Oral• single dose• 1 doses total

    Single dosing session; traditional ayahuasca decoction (Psychotria viridis + Banisteriopsis caapi).

Placebo

inactive

Passive inert placebo comparator.

Interventions

  • Placebo
    via Oral• single dose• 1 doses total

    Single-dose passive placebo.

Participants

Ages
18 – 60
Sexes
Male & Female

Inclusion 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

  • 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.

Study Details

Locations

Draulio B de Araujo — Natal, Rio Grande do Norte, Brazil

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