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Trial registered on ANZCTR
Registration number
ACTRN12623000486628
Ethics application status
Approved
Date submitted
1/05/2023
Date registered
12/05/2023
Date last updated
14/06/2024
Date data sharing statement initially provided
12/05/2023
Type of registration
Prospectively registered
Titles & IDs
Public title
Assessing the effects of Lysergic acid diethylamide (LSD) microdosing in people experiencing depression (LSDDEP1)
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Scientific title
An open-label pilot trial assessing tolerability and feasibility of LSD microdosing in patients with major depressive disorder (LSDDEP1).
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Secondary ID [1]
309475
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None
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Universal Trial Number (UTN)
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Trial acronym
LSDDEP1
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
major depressive disorder
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Condition category
Condition code
Mental Health
326636
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0
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Depression
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Sublingually administered Lysergic acid diethylamide (LSD) solution.
Two doses taken every week for eight weeks.
Starting dose is 8 mcg on a pre-defined titration schedule. The dose will be increased by 1 mcg each time and reduced by 3 mcg if participants do not find the new dose tolerable. Titration limits are 5-15 mcg.
Adherence will be monitored by participants sending video recordings of each dose administration to the study team
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Intervention code [1]
325898
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Treatment: Drugs
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Percentage of participants completing the dosing regimen determined by audit of study case report files.
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Assessment method [1]
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Timepoint [1]
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At the conclusion of study
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Primary outcome [2]
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Percentage of attended clinic visits once enrolled determined by audit of study case report files.
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Assessment method [2]
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Timepoint [2]
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At the conclusion of study
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Secondary outcome [1]
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Total score of the Montomery-Asberg Depressive Rating Scale (MADRS)
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Assessment method [1]
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Timepoint [1]
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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
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Eligibility
Key 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
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Minimum age
21
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 2
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
27/06/2023
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Actual
14/08/2023
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Date of last participant enrolment
Anticipated
3/06/2024
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Actual
18/12/2023
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Date of last data collection
Anticipated
8/08/2024
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Actual
18/04/2024
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Sample size
Target
20
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Accrual to date
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Final
20
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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Health Reseach Council of New Zealand
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Address [1]
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Health Research Council of New Zealand PO Box 5541, Victoria Street West, Auckland 1142
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Country [1]
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New Zealand
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Funding source category [2]
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Commercial sector/Industry
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Name [2]
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MindBio Therapeutics Ltd
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Address [2]
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Level 4, 91-97 William Street
Melbourne, Victoria, Australia 3000
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Country [2]
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Australia
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Primary sponsor type
University
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Name
The University of Auckland
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Address
University of Auckland
Private Bag 92019
Auckland 1142
New Zealand
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Country
New Zealand
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Southern HDEC
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Ethics committee address [1]
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Health and Disability Ethics Committees Ministry of Health 133 Molesworth Street PO Box 5013 Wellington 6011
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Ethics committee country [1]
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New Zealand
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Date submitted for ethics approval [1]
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Approval date [1]
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14/12/2022
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Ethics approval number [1]
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Summary
Brief summary
Depressive disorders are the leading cause of “years lived with disability” in New Zealand and there is a clear need for the development of new, alternative antidepressant therapies. In light of problems with the tolerability and efficacy of available treatments, a global trend is emerging for patients to self-treat depression with microdoses of psychedelic drugs such as lysergic acid diethylamide (LSD) and psilocybin. Beyond anecdotal reports from those who self-medicate in this way, there are few clinical trials that have evaluated this practice. In our recently published Phase 1 study in healthy volunteers (https://pubmed.ncbi.nlm.nih.gov/36997080/; ACTRN12621000436875) , we determined that LSD microdosing was relatively safe in this cohort and well-tolerated. Further the data demonstrate that conducting such microdosing studies is feasible with excellent adherence and compliance to regimen observed. In this open-label pilot trial with patients with major depressive disorder (MDD) we will test the tolerability and feasibility of an 8 week regimen of LSD microdosing in this patient group.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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A/Prof Suresh Muthukumaraswamy
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Address
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School of Pharmacy The University of Auckland Private Bag 92019 Auckland 1142
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Country
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New Zealand
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Phone
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+64 093737599
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Fax
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Email
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sd.muthu@auckland.ac.nz
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Contact person for public queries
Name
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Suresh Muthukumaraswamy
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Address
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School of Pharmacy The University of Auckland Private Bag 92019 Auckland 1142
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Country
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New Zealand
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Phone
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+64 093737599
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Fax
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Email
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sd.muthu@auckland.ac.nz
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Contact person for scientific queries
Name
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Suresh Muthukumaraswamy
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Address
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School of Pharmacy The University of Auckland Private Bag 92019 Auckland 1142
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Country
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New Zealand
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Phone
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+64 093737599
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Fax
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Email
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sd.muthu@auckland.ac.nz
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Commercial sensitivity
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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