Major Depressive DisorderPhase 2NCT05675800
Psilocybin for Major Depressive Disorder
A Phase 2 study testing Psilocybin in people with Major Depressive Disorder, run by Washington University School of Medicine.
Trial summary
The goal of this study is to assess the effectiveness of psilocybin for the treatment of Major Depressive Disorder and potential therapeutic mechanisms. Enrolled participants will receive a single active dose of psilocybin, or a dose considered high enough to treat depression, administered orally with accompanying… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Psilocybin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2024to 31 Mar 2025
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Currently meeting DSM-V Criteria for a Major Depressive Episode of at least mild-moderate severity
- Aged 18-85
- Ability and willingness to attend study visits and complete study assessments
Who cannot join
- Presence of medical conditions at screening that may affect the safe administration of psilocybin (including, but not limited to: AST/ALT > 150, QTc > 450ms, MELD > 9)
- Depression deemed secondary to a severe medical condition
- Recent use of any classical psychedelic drug or MDMA
- Recent use of any interventional psychiatric treatment (including: ECT, ketamine, esketamine, TMS)
- Intention to begin any new treatment for depression prior to primary outcome determination
- Use of any excluded medication
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- Active substance use disorder
- Presence of any psychiatric condition that may interfere with the safe administration of psilocybin
- Active suicidal ideation
About this study
Official title: Psilocybin for the Treatment of Major Depressive Disorder
The goal of this study is to assess the effectiveness of psilocybin for the treatment of Major Depressive Disorder and potential therapeutic mechanisms. Enrolled participants will receive a single active dose of psilocybin, or a dose considered high enough to treat depression, administered orally with accompanying psychological support.
- Conditions
- Major Depressive Disorder
- Being tested
- Psilocybin
- 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.
PsilocybinDrug
Psilocybin administered with psychological support
| Study group | Role | What they receive |
|---|---|---|
| Psilocybin Active Dose Treatment A | Experimental | Psilocybin Receives: Drug: Psilocybin |
| Psilocybin Active Dose Treatment B | Experimental | Psilocybin Receives: Drug: Psilocybin |
What is being measured
The primary outcome is the main question the study is designed to answer.
MADRS (Montgomery-Asberg Depression Rating Scale) Change from Baseline
Depression severity rating scale, range 0-60 with higher scores indicating more severe symptoms
Measured: 3 weeks post-treatment
Adverse Events
Rates of adverse events related to treatment, as determined by multiple data collection mechanisms
Measured: Up to 12 weeks post-treatment
Study Retention and Completion
Rates of successful attendance of study visits and completion of study
Measured: Throughout study participation (12-17 weeks)
Secondary outcomes (1)
MADRS (Montgomery-Asberg Depression Rating Scale) Change from Baseline
Depression severity rating scale, range 0-60 with higher scores indicating more severe symptoms
Measured: 12 weeks post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2023
- Study start1 Jan 2024 (estimated)
- Primary completion1 Jan 2025 (estimated)
- Study completion31 Mar 2025 (estimated)
Why it stopped: Resident who was tasked with coordinating this study is no longer able to do so.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Ginger E Nicol, Washington University School of Medicine
- Investigators
- Ginger Nicol, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05675800
- Sponsor's protocol ID
- 202209153
- Other IDs
- R25MH112473
- Status last verified
- Jul 2024
- First submitted
- 22 Nov 2022
- Last updated
- 25 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol and analysis plan will be publicly available on publication of the research. Individual researchers can request individual participant data collected during the trial, after deidentification, for specifically outlined research-related purposes upon publication.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psilocybin for the Treatment of Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT05675800
- Acronym / sponsor ID
- 202209153
- Conditions
- Major Depressive Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Resident who was tasked with coordinating this study is no longer able to do so.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 9 Jan 2023 (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.
The goal of this study is to assess the effectiveness of psilocybin for the treatment of Major Depressive Disorder and potential therapeutic mechanisms. Enrolled participants will receive a single active dose of psilocybin, or a dose considered high enough to treat depression, administered orally with accompanying psychological support.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psilocybin Active Dose Treatment A | Experimental | Drug: PsilocybinPsilocybin |
| Psilocybin Active Dose Treatment B | Experimental | Drug: PsilocybinPsilocybin |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Currently meeting DSM-V Criteria for a Major Depressive Episode of at least mild-moderate severity
- Aged 18-85
- Ability and willingness to attend study visits and complete study assessments
Key exclusion criteria (9 listed)
- Presence of medical conditions at screening that may affect the safe administration of psilocybin (including, but not limited to: AST/ALT > 150, QTc > 450ms, MELD > 9)
- Depression deemed secondary to a severe medical condition
- Recent use of any classical psychedelic drug or MDMA
- Recent use of any interventional psychiatric treatment (including: ECT, ketamine, esketamine, TMS)
- Intention to begin any new treatment for depression prior to primary outcome determination
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 |
|---|---|---|
| PsilocybinPsilocybin administered with psychological support | Drug | Psilocybin Active Dose Treatment A, Psilocybin Active Dose Treatment B |
Primary outcome
MADRS (Montgomery-Asberg Depression Rating Scale) Change from Baseline
Time frame: 3 weeks post-treatment
Depression severity rating scale, range 0-60 with higher scores indicating more severe symptoms
Adverse Events
Time frame: Up to 12 weeks post-treatment
Rates of adverse events related to treatment, as determined by multiple data collection mechanisms
Study Retention and Completion
Time frame: Throughout study participation (12-17 weeks)
Rates of successful attendance of study visits and completion of study
1 secondary outcome
MADRS (Montgomery-Asberg Depression Rating Scale) Change from Baseline
Time frame: 12 weeks post-treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2024.
- Individual participant dataSharing planned: Yes. Study protocol and analysis plan will be publicly available on publication of the research. Individual researchers can request individual participant data collected during the trial, after deidentification, for specifically outlined research-related purposes upon publication.
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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.
Ginger Nicol, MD principal investigator
Washington University School of Medicine
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Psilocybin in people with Major Depressive Disorder, run by Washington University School of Medicine.
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 9 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: withdrawn, as of the sponsor's last update on 25 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
MADRS (Montgomery-Asberg Depression Rating Scale) Change from Baseline (time frame: 3 weeks post-treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jul 2024.