Major Depressive DisorderPhase 2LADNCT03866252
LSD Therapy for Persons Suffering From Major Depression
A Phase 2 study testing LSD in people with Major Depressive Disorder, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- LSD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Nov 2019to 1 Dec 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Major Depressive Disorder according to Diagnostic and Statistical Manual of Mental Disorders (DSM-V)
- > 25 years
- Sufficient understanding of the German language
Who cannot join
- < 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Universitäre Psychiatrische Kliniken
Basel, Canton of Basel-City, 4002
About this study
Official title: LSD Therapy for Persons Suffering From Major Depression: A Randomised, Double-blind, Active-placebo Controlled Phase II Study
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.
Read more
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.
- Conditions
- Major Depressive Disorder
- Being tested
- LSD
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LSDDrug
Also called Lysergic Acid Diethylamide
LSD administration per os
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Subjects in the treatment arm will receive 100 μg LSD (first session) and 100 or 200 μg LSD (second session) per os. Receives: Drug: LSD |
| Control Arm | Active comparator | Subjects in the control arm will receive 25 μg LSD (first session) and 25 μg LSD (second session) per os. Receives: Drug: LSD |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Baseline; 1 week before first intervention; 2 weeks after first intervention; 2, 6, and 12 weeks after LSD
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2019
- Study start1 Nov 2019
- Primary completion29 Sep 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Psychiatry Basel (UPK Basel; Prof. Dr. med. Stefan Borgwardt)
- Responsible party
- Sponsor
- Investigators
- Dr. med. Felix Müller, MD, Study chair, Department of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03866252
- Sponsor's protocol ID
- BASEC 2018-02370
- Acronym
- LAD
- Status last verified
- Apr 2025
- First submitted
- 8 Feb 2019
- Last updated
- 23 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Muller F, Zaczek H, Becker AM, Ley L, Borgwardt S, Santos de Jesus J, Loh N, Kohut J, Auernig M, Boehlke C, Liechti ME. Efficacy and safety of low- versus high-dose-LSD-assisted therapy in patients with major depression: A randomized trial. Med. 2025 Sep 12;6(9):100725. doi: 10.1016/j.medj.2025.100725. Epub 2025 Jun 6.
PubMed 40482648
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LSD Therapy for Persons Suffering From Major Depression: A Randomised, Double-blind, Active-placebo Controlled Phase II Study
- ClinicalTrials.gov ID
- NCT03866252
- Acronym / sponsor ID
- LAD / BASEC 2018-02370
- Conditions
- Major Depressive Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- Department of Psychiatry Basel (UPK Basel; Prof. Dr. med. Stefan Borgwardt)
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 29 Sep 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 7 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Drug: LSDSubjects in the treatment arm will receive 100 μg LSD (first session) and 100 or 200 μg LSD (second session) per os. |
| Control Arm | Active comparator | Drug: LSDSubjects in the control arm will receive 25 μg LSD (first session) and 25 μg LSD (second session) per os. |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Major Depressive Disorder according to Diagnostic and Statistical Manual of Mental Disorders (DSM-V)
- > 25 years
- Sufficient understanding of the German language
Key exclusion criteria (12 listed)
- < 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LSDAlso: Lysergic Acid DiethylamideLSD administration per os | Drug | Control Arm, Treatment Arm |
Primary outcome
Change in depressive symptoms assessed by questionnaire compared with active placebo
Time frame: Baseline; 1 week before first intervention; 2 weeks after first intervention; 2, 6, and 12 weeks after LSD
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.
Change in depressive symptoms assessed by questionnaire compared with active placebo
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2025.
- Derived from this study: PubMed 40482648Muller F, Zaczek H, Becker AM, Ley L, Borgwardt S, Santos de Jesus J, Loh N, Kohut J, Auernig M, Boehlke C, Liechti ME. Efficacy and safety of low- versus high-dose-LSD-assisted therapy in patients with major depression: A randomized trial. Med. 2025 Sep 12;6(9):100725. doi: 10.1016/j.medj.2025.100725. Epub 2025 Jun 6.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. med. Felix Müller, MD study chair
Department of Psychiatry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LSD in people with Major Depressive Disorder, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in depressive symptoms assessed by questionnaire compared with active placebo (time frame: Baseline; 1 week before first intervention; 2 weeks after first intervention; 2, 6, and 12 weeks after LSD). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03866252, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2025.