LSD Therapy for Persons Suffering From Major Depression
Status:
Recruiting
Trial end date:
2023-12-31
Target enrollment:
Participant gender:
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-SR, BDI), anxiety (STAI), and
general psychopathology (SCL-90) compared with active-placebo-assisted psychotherapy.
Phase:
Phase 2
Details
Lead Sponsor:
University Hospital, Basel, Switzerland
Collaborator:
Department of Psychiatry Basel (UPK Basel; Prof. Dr. med. Stefan Borgwardt)