Clinical TrialMajor Depressive Disorder (MDD)LSDLSDCompleted

LSD Therapy for Persons Suffering From Major Depression

Randomised, double-blind, active-placebo-controlled Phase II trial (n=60) of two-session LSD-assisted psychotherapy (100 µg → 100/200 µg) versus low-dose LSD (25 µg ×2) for Major Depressive Disorder.

Target Enrollment
60 participants
Study Type
Phase II interventional
Design
Randomized, quadruple Blind

Detailed Description

This randomised, double-blind, parallel-group trial tests LSD-assisted psychotherapy in patients with Major Depressive Disorder using two dosing sessions and an active low-dose comparator.

Sixty participants aged over 25 will receive psychotherapy with either moderate/high-dose LSD (100 µg then 100 or 200 µg) or low-dose LSD (25 µg in both sessions); outcomes include depressive symptoms (IDS, BDI), anxiety (STAI) and general psychopathology (SCL-90).

Masking is quadruple and the trial is registered on ClinicalTrials.gov (NCT03866252); primary purpose is treatment.

Study Protocol

Preparation

sessions

Dosing

2 sessions

Integration

sessions

Therapeutic Protocol

Manualized psychotherapy included

Study Arms & Interventions

Treatment Arm

experimental

Two-session LSD-assisted psychotherapy: 100 µg in session 1; session 2 100 µg or 200 µg (dose escalation).

Interventions

  • LSD100 - 200 µg
    via Oral• two sessions• 2 doses total

    Session 1 100 µg; session 2 100 or 200 µg per protocol; oral administration paired with psychotherapy.

Control Arm

active comparator

Two-session active-placebo (low-dose LSD) with psychotherapy.

Interventions

  • LSD25 µg
    via Oral• two sessions• 2 doses total

    25 µg LSD in both sessions as active-placebo comparator.

Participants

Ages
25 – 99
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • Major Depressive Disorder according to Diagnostic and Statistical Manual of Mental Disorders (DSM-V)
  • > 25 years
  • Sufficient understanding of the German language

Exclusion Criteria

  • Exclusion Criteria:
  • < 25 years
  • Concomitant diagnosis of past or present psychotic disorder
  • Concomitant diagnosis of past or present bipolar disorder
  • First degree relative with a psychotic disorder
  • Unable or unwilling to discontinue antidepressant medication
  • Pregnancy or breastfeeding
  • Known hypersensitivity to LSD
  • Somatic disorders including central nervous system (CNS) involvement
  • Known or suspected non-compliance, drug or alcohol abuse
  • Metal implants
  • Weight < 42 kg
  • Suicide risk or very likely to require psychiatric hospitalisation

Study Details

  • Status
    Completed
  • Phase
    Phase II
  • Type
    interventional
  • Design
    Randomizedquadruple Blind
  • Target Enrollment60 participants
  • Timeline
    Start: 2019-01-11
    End: 2022-12-01
  • Compounds
    LSDLSD
  • Topic
    Major Depressive Disorder (MDD)

Locations

Universitäre Psychiatrische Kliniken — Basel, Canton of Basel-City, Switzerland

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