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NCT03866252: LAD
LSD Therapy for Persons Suffering From Major Depression
Phase 2 trial testing LSD in Major Depressive Disorder in 60 participants. Completed in 1 December 2022.
29 September 2022
Quick facts
| Lead sponsor | University Hospital, Basel, Switzerland |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 60 |
| Start date | 1 November 2019 |
| Primary completion | 29 September 2022 |
| Estimated completion | 1 December 2022 |
| Sites | 1 location across Switzerland |
Drugs / interventions tested
- LSD — full drug profile →
Conditions studied
- Major Depressive Disorder — all drugs for Major Depressive Disorder →
Sponsor
University Hospital, Basel, Switzerland
Who can join
25 and older, any sex, with Major Depressive Disorder. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Role of the 5-HT<sub>2A</sub> Receptor in Acute Effects of LSD on Empathy and Circulating Oxytocin.
Holze F, Avedisian I, Varghese N, Eckert A, et al · · 2021 · cited 48× · PMID 34326773 · DOI 10.3389/fphar.2021.711255 -
Safety pharmacology of acute LSD administration in healthy subjects.
Holze F, Caluori TV, Vizeli P, Liechti ME. · · 2022 · cited 38× · PMID 34515824 · DOI 10.1007/s00213-021-05978-6 -
Psychedelic Therapy's Transdiagnostic Effects: A Research Domain Criteria (RDoC) Perspective.
Kelly JR, Gillan CM, Prenderville J, Kelly C, et al · · 2021 · cited 36× · PMID 34975593 · DOI 10.3389/fpsyt.2021.800072 -
Psychedelic therapies reconsidered: compounds, clinical indications, and cautious optimism.
Mitchell JM, Anderson BT. · · 2024 · cited 32× · PMID 37479859 · DOI 10.1038/s41386-023-01656-7 -
The Use of Psychedelics in the Treatment of Medical Conditions: An Analysis of Currently Registered Psychedelics Studies in the American Drug Trial Registry.
Kurtz JS, Patel NA, Gendreau JL, Yang C, et al · · 2022 · cited 19× · PMID 36259015 · DOI 10.7759/cureus.29167 -
Efficacy and safety of low- versus high-dose-LSD-assisted therapy in patients with major depression: A randomized trial.
Müller F, Zaczek H, Becker AM, Ley L, et al · · 2025 · cited 9× · PMID 40482648 · DOI 10.1016/j.medj.2025.100725 -
Pharmacological and non-pharmacological predictors of the LSD experience in healthy participants.
Vizeli P, Studerus E, Holze F, Schmid Y, et al · · 2024 · cited 9× · PMID 39231959 · DOI 10.1038/s41398-024-03074-9 -
New agents and perspectives in the pharmacological treatment of major depressive disorder.
Sanches M, Quevedo J, Soares JC. · · 2021 · cited 9× · PMID 33159975 · DOI 10.1016/j.pnpbp.2020.110157
Verify or expand the search:
- PubMed search for NCT03866252
- Europe PMC full search
- ASCO Meeting Library
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- bioRxiv preprints
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03866252 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Hospital, Basel, Switzerland
- Last refreshed: 23 April 2025
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