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

Phase 2

Completed

• Conditions: major depressive disorder; Mental Health - Depression

• Registration Number: ACTRN12623000486628
• Lead Sponsor: The University of Auckland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-12
• Study Completion: 2024-04-18
• Last Update Posted: 24 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

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 the DSM-5 criteria for MDD
5. Have a MADRS score between 18-35 at the time of screening.
6. Ability to take oral medication and be willing to adhere to the study intervention regimen.
7. For persons of child-bearing potential: agree to use an effective or highly effective contraception

Exclusion Criteria

1. Current or past history 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 use of alcohol defined as a score on the AUDIT of 16 or greater.
7. Stage II or higher treatment-resistant depression as defined by the Thase and Rush (1997)
staging criteria for the current depressive episode.
8. BMI <18 and > 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 on-going 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 & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of participants completing the dosing regimen determined by audit of study case report files.[ At the conclusion of study];Percentage of attended clinic visits once enrolled determined by audit of study case report files.[ At the conclusion of study]

Secondary Outcome Measures

Name	Time	Method
Total score of the Montomery-Asberg Depressive Rating Scale (MADRS)[ 8 weeks post-commencement of the intervention. Additional assessments are made at baseline (pre-commencement), 2 weeks, 4 weeks and 6 weeks post-commencement of intervention]