Assessing the effects of Lysergic acid... — Clinical Trial Details

Open-label, single-group Phase II pilot (n=20) testing sublingual LSD solution microdosing twice weekly for 8 weeks with a predefined titration (start 8 µg, +1 µg per dose, limits 5–15 µg; reduce by 3 µg if not tolerated). Adherence monitored via video-recorded dosing.

Primary outcomes: percentage of participants completing the dosing regimen (audit of case report files) and total MADRS score at 8 weeks. Assessments at baseline, 2, 4, 6 and 8 weeks.

1. Provision of signed and dated informed consent form.
2. Stated willingness to comply with all study procedures and availability for the duration of the study.
3. Any gender identity aged 21-65 years.
4. Diagnosis of Major Depressive Disorder (MDD) as per DSM-5 criteria.
5. MADRS score between 18 and 35 at screening.
6. Ability to take oral medication and willing to adhere to study intervention regimen.
7. For persons of child-bearing potential: agree to use effective or highly effective contraception.

1. Current or past history of schizophrenia or other psychotic disorders, or bipolar I or II disorder.
2. Diagnosis of PTSD as assessed by clinical interview.
3. Diagnosis of an eating disorder as assessed by clinical interview.
4. Risk of suicide as determined by The Columbia-Suicide Severity Rating Scale (C-SSRS).
5. Substance dependence in the previous 6 months.
6. Problematic alcohol use (AUDIT score ≥16).
7. Stage II or higher treatment-resistant depression (Thase and Rush 1997 staging) for the current episode.
8. BMI <18 or >35.
9. Planned or current pregnancy or lactation.
10. Cardiovascular conditions including abnormal heart rate or blood pressure.
11. Significant renal or hepatic impairment.
12. Abnormal 12-lead ECG as judged by a study physician.
13. Abnormal laboratory test findings as judged by a study physician.
14. Use of monoamine oxidase inhibitors, methylphenidate or dexamphetamine.
15. Excessive ongoing medication burden as determined by a study physician.
16. Any lifetime history of psychedelic microdosing.
17. Use of serotonergic psychedelic drugs in the last year.
18. Lifetime history of self-medicating with psychedelics to treat their depression.

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Assessing the effects of Lysergic acid diethylamide (LSD) microdosing in people experiencing depression (LSDDEP1)

Detailed Description

Study Protocol

Preparation

Dosing

Locations

Related Publications

What is it like to microdose LSD for depression? a thematic analysis of participant interviews from an open-label trial

Integration

Study Arms & Interventions

LSD microdose

Interventions

Participants

Inclusion Criteria

Exclusion Criteria

Study Details

LSD microdosing in major depressive disorder: results from an open-label trial

LSD microdosing for major depressive disorder: Mood and pharmacokinetic outcomes from a Phase 2a trial