CompletedPhase 2

LSD Therapy for Persons Suffering From Major Depression

NCT03866252 · LAD · University Hospital, Basel, Switzerland

Closed to entry

Status

Not accepting participants

Phase 2

Phase

Target enrolment

Study sites

Outside the US

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

Change in depressive symptoms assessed by questionnaire compared with active placebo
Measured over Baseline; 1 week before first intervention; 2 weeks after first intervention; 2, 6, and 12 weeks after LSD
Change in depressive symptoms assessed by questionnaire compared with active placebo
Measured over Baseline; 1 week before first intervention; 2 weeks after first intervention; 2, 6, and 12 weeks after LSD

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

25 Years

Ages

All

Sex

Not accepted

Healthy volunteers

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

Where

1 study site

Facility	City	Region	Country
Universitäre Psychiatrische Kliniken	Basel	Canton of Basel-City	Switzerland

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

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NCT03866252 on ClinicalTrials.gov →

Last updated in the registry 2025-04-23. Registry records change; this page reflects the data build of 2026-08-25.

Where this trial sits

Substance

Indication

Major Depressive Disorder173

All 48 trials from University Hospital, Basel, Switzerland →