LSD Therapy for Persons Suffering From Major Depression

University Hospital, Basel, Switzerland60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Major Depressive Disorder

Eligibility

Sex: ALLMin age: 25 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change in depressive symptoms assessed by questionnaire compared with active placebo

Inventory of Depressive Symptomatology (IDS-C, clinician-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.

Time frame: Baseline; 1 week before first intervention; 2 weeks after first intervention; 2, 6, and 12 weeks after LSD