Clinical TrialMajor Depressive Disorder (MDD)LSDRecruiting

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

This open-label pilot trial (n=20) aims to evaluate the tolerability and feasibility of LSD microdosing in patients with major depressive disorder (MDD).

Target Enrollment
20 participants
Study Type
Phase II interventional
Design
Non-randomized

Detailed Description

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.

Study Protocol

Preparation

sessions

Dosing

16 sessions

Integration

sessions

Study Arms & Interventions

LSD microdose

experimental

Sublingual LSD solution, titrated microdoses twice weekly for 8 weeks.

Interventions

  • LSD8 µg
    via Sublingual• twice weekly• 16 doses total

    Start 8 µg; titrate +1 µg each dose; reduce by 3 µg if not tolerated; titration limits 5–15 µg; adherence monitored by video of each dose.

Participants

Ages
21 – 65
Sexes
Male & Female

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Study Details

  • Status
    Recruiting
  • Phase
    Phase II
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment20 participants
  • Timeline
    Start: 2023-08-14
    End: 2024-08-08
  • Compound
    LSD
  • Topic
    Major Depressive Disorder (MDD)

Locations

Unknown facility — Australia

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