LSD Therapy for Persons Suffering From Major Depression

Phase 2

Completed

• Conditions: Major Depressive Disorder
• Interventions: Drug: LSD

• Registration Number: NCT03866252
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief Summary

Background: Major Depressive Disorder is one of the most prevalent mental illnesses, leading to substantial personal distress and economical consequences. Pharmacological Treatment is limited and relapse is frequent.

Lysergic acid diethylamide (LSD) was extensively investigated in humans in the 1950s and 1960s and was shown to attenuate depressive symptoms. Clinical research with LSD ended in the 1970s due to regulatory restrictions but its use for personal and recreational purposes continued. In recent years, there has been a renewed interest in the use of hallucinogens in psychiatric research and practices, reconsidering LSD's antidepressant potential. Larger, well-designed and placebo-controlled studies are warranted. This study will evaluate the potential benefits of LSD-assisted psychotherapy in patients suffering from Major Depressive Disorder.

Objective: To test the efficacy of LSD in patients with Major Depressive Disorder.

Design: Randomised, double-blind, active-placebo-controlled trial using either two moderate to high doses of LSD (100 µg and 100 µg or 100 µg and 200 µg) as intervention and two low doses of LSD (25 µg and 25 µg) as active-placebo control.

Participants: 60 patients aged \> 25 years with Major Depressive Disorder (according to DSM-V).

Main outcome measures: Change in depressive symptomatology (IDS, BDI), anxiety (STAI), and general psychopathology (SCL-90) compared with active-placebo-assisted psychotherapy.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-02-08
• Study First Submitted QC: 2019-03-04
• Study First Posted: 2019-03-07
• Study Start: 2019-11-01
• Primary Completion: 2022-09-29
• Study Completion: 2022-12-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-17
• Last Update Posted: 2025-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

• < 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Arm	LSD	Subjects in the control arm will receive 25 μg LSD (first session) and 25 μg LSD (second session) per os.
Treatment Arm	LSD	Subjects in the treatment arm will receive 100 μg LSD (first session) and 100 or 200 μg LSD (second session) per os.

Primary Outcome Measures

Name	Time	Method
Change in depressive symptoms assessed by questionnaire compared with active placebo	Baseline; 1 week before first intervention; 2 weeks after first intervention; 2, 6, and 12 weeks after LSD	Inventory of Depressive Symptomatology (IDS-SR, self-rated). Scores are obtained by summing responses to the items, with a total score ranging from 0 to 84 and higher scores indicating more and/or stronger depressive symptoms.

Trial Locations

Locations (1)

Universitäre Psychiatrische Kliniken; 🇨🇭 Basel, Basel-Stadt, Switzerland