Treatment Resistant DepressionPhase 2NCT05220410
The Safety and Efficacy of Psilocybin in Patients With Treatment-resistant Depression and Chronic Suicidal Ideation
A Phase 2 study testing Psilocybin in people with Treatment Resistant Depression and Suicidal Ideation, run by Sheppard Pratt Health System at 1 site in United States.
Trial summary
This study aims to explore the safety and tolerability of a single dose of psilocybin (25mg) administered under supportive conditions to adult participants with TRD and chronic suicidal ideation Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Treatment Resistant Depression, Suicidal Ideation
- What is being tested?
- Psilocybin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Mar 2022to 12 May 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between 18 and 65 years of age at Screening
- Diagnosis of Major Depressive Disorder (MDD)
- Significant level of suicidal thoughts with active ideation and without immediate intent
- Failure to respond to 2 medications in the current episode
Who cannot join
- Current or past history of schizophrenia, psychotic disorder, bipolar disorder, borderline personality disorder, etc.
- Current alcohol or substance use disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
Sheppard Pratt Health System
Baltimore, Maryland, 21204
About this study
This study aims to explore the safety and tolerability of a single dose of psilocybin (25mg) administered under supportive conditions to adult participants with TRD and chronic suicidal ideation
- Conditions
- Treatment Resistant Depression, Suicidal Ideation
- Being tested
- Psilocybin
- Keywords
- Psilocybin, Psychedelic, Major depression, Treatment resistant depression, Suicidal ideation
- Medical subject headings
- Depressive Disorder, Treatment-Resistant, Suicidal Ideation, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsilocybinDrug
Open-Label
| Study group | Role | What they receive |
|---|---|---|
| Psilocybin | Experimental | 25mg of Psilocybin Receives: Drug: Psilocybin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Scale for Suicidal Ideation (MSSI)
The MSSI is an 18-item clinician rated scale to assess the presence or absence of suicide ideation and the degree of severity of suicidal ideas. Each of the 18 items is rated on a scale of 0 to 3 where a higher score indicates greater suicidal severity.
Measured: Baseline (V2) to Day 1 (V4), Week 1 (V5), Week 2 (V6), Week 3 (V7), Week 6 (V8), Week 9 (V9) and Week 12 (V10)
Secondary outcomes (5)
Montgomery-Åsberg Depression Rating Scale (MADRS)
The MADRS is a clinician rated scale measuring depression severity, consisting of 10 items, each scored from 0 (normal) to 6 (severe), for a total possible score of 60; higher scores denote greater severity.
Measured: Baseline (V2) to Day 1 (V4), Week 1 (V5), Week 2 (V6), Week 3 (V7), Week 6 (V8), Week 9 (V9), and Week 12 (V10)
Concise Health Risk Tracking Self Report 12 Items (CHRT-SR)
The CHRT-SR is a 12-item self-report measure that systematically assesses both suicidal thinking and associated thoughts that might indicate the propensity for suicidal acts.
Measured: Baseline (V2) to Day 1 (V4), Week 1 (V5), Week 2 (V6), Week 3 (V7), Week 6 (V8), Week 9 (V9) and Week 12 (V10)
Columbia-Suicide Severity Rating Scale (C-SSRS)
The C-SSRS is a semi-structured interview designed to assess the severity and intensity of suicidal ideation, suicidal behavior, and non-suicidal self injurious behavior over a specified time period. The measurement of suicidal ideation is based on five "yes" or "no" questions with accompanying descriptions arranged in order of increasing severity.
Measured: Baseline (V2) to Day 1 (V4), Week 1 (V5), Week 2 (V6), Week 3 (V7), and Week 12 (V10)
Clinical Global Impression - Modified for Depression (CGI-D)
The CGI is a 3-item observer-rated scale that measures illness severity, global improvement or change and therapeutic response.
Measured: Baseline (V2) to Week 3 (V7) and Week 12 (V10)
Clinical Global Impressions - Modified for Suicidal Ideation (CGI-SI)
The CGI is a 3-item observer-rated scale that measures illness severity, global improvement or change and therapeutic response.
Measured: Baseline (V2) to Week 3 (V7), and Week 12 (V10)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2022
- Study start28 Mar 2022
- Primary completion12 May 2025
- Study completion12 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Treatment Resistant DepressionStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheppard Pratt Health System
- Sponsor type
- University, hospital or other
- Collaborators
- COMPASS Pathways
- Responsible party
- Principal investigator, Scott T. Aaronson, M.D, Sheppard Pratt Health System
- Investigators
- Scott Aaronson, MD, Principal investigator, Sheppard Pratt Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05220410
- Sponsor's protocol ID
- 49348
- Status last verified
- Jul 2025
- First submitted
- 21 Jan 2022
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
van der Vaart A, LaPratt J, Swartz K, Shoultz A, Lauterbach M, Suppes T, Sackeim HA, Aaronson ST. Efficacy and Safety of a Single Dose of Psilocybin for Chronic Suicidal Ideation: An Open-Label Trial. J Clin Psychiatry. 2026 May 13;87(2):26m16338. doi: 10.4088/JCP.26m16338.
PubMed 42138588
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy of Psilocybin in Patients With Treatment-resistant Depression and Chronic Suicidal Ideation
- ClinicalTrials.gov ID
- NCT05220410
- Acronym / sponsor ID
- 49348
- Conditions
- Treatment Resistant Depression, Suicidal Ideation
- Keywords
- Psilocybin, Psychedelic, Major depression, Treatment resistant depression, Suicidal ideation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Sheppard Pratt Health SystemUniversity, hospital or other
- Collaborators
- COMPASS Pathways
- Study start
- 28 Mar 2022 (actual)
- Primary completion
- 12 May 2025 (actual)
- Study completion
- 12 May 2025 (actual)
- First posted
- 2 Feb 2022 (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.
This study aims to explore the safety and tolerability of a single dose of psilocybin (25mg) administered under supportive conditions to adult participants with TRD and chronic suicidal ideation
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Psilocybin | Experimental | Drug: Psilocybin25mg of Psilocybin |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Between 18 and 65 years of age at Screening
- Diagnosis of Major Depressive Disorder (MDD)
- Significant level of suicidal thoughts with active ideation and without immediate intent
- Failure to respond to 2 medications in the current episode
Key exclusion criteria (2 listed)
- Current or past history of schizophrenia, psychotic disorder, bipolar disorder, borderline personality disorder, etc.
- Current alcohol or substance use disorder
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 |
|---|---|---|
| PsilocybinOpen-Label | Drug | Psilocybin |
Primary outcome
Modified Scale for Suicidal Ideation (MSSI)
Time frame: Baseline (V2) to Day 1 (V4), Week 1 (V5), Week 2 (V6), Week 3 (V7), Week 6 (V8), Week 9 (V9) and Week 12 (V10)
The MSSI is an 18-item clinician rated scale to assess the presence or absence of suicide ideation and the degree of severity of suicidal ideas. Each of the 18 items is rated on a scale of 0 to 3 where a higher score indicates greater suicidal severity.
5 secondary outcomes
Montgomery-Åsberg Depression Rating Scale (MADRS)
Time frame: Baseline (V2) to Day 1 (V4), Week 1 (V5), Week 2 (V6), Week 3 (V7), Week 6 (V8), Week 9 (V9), and Week 12 (V10)
Concise Health Risk Tracking Self Report 12 Items (CHRT-SR)
Time frame: Baseline (V2) to Day 1 (V4), Week 1 (V5), Week 2 (V6), Week 3 (V7), Week 6 (V8), Week 9 (V9) and Week 12 (V10)
Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Baseline (V2) to Day 1 (V4), Week 1 (V5), Week 2 (V6), Week 3 (V7), and Week 12 (V10)
Clinical Global Impression - Modified for Depression (CGI-D)
Time frame: Baseline (V2) to Week 3 (V7) and Week 12 (V10)
Clinical Global Impressions - Modified for Suicidal Ideation (CGI-SI)
Time frame: Baseline (V2) to Week 3 (V7), and Week 12 (V10)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Derived from this study: PubMed 42138588van der Vaart A, LaPratt J, Swartz K, Shoultz A, Lauterbach M, Suppes T, Sackeim HA, Aaronson ST. Efficacy and Safety of a Single Dose of Psilocybin for Chronic Suicidal Ideation: An Open-Label Trial. J Clin Psychiatry. 2026 May 13;87(2):26m16338. doi: 10.4088/JCP.26m16338.
- Individual participant dataSharing planned: No
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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.
Scott Aaronson, MD principal investigator
Sheppard Pratt Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Psilocybin in people with Treatment Resistant Depression and Suicidal Ideation, run by Sheppard Pratt Health System at 1 site in United States.
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 4 inclusion and 2 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: finished, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Modified Scale for Suicidal Ideation (MSSI) (time frame: Baseline (V2) to Day 1 (V4), Week 1 (V5), Week 2 (V6), Week 3 (V7), Week 6 (V8), Week 9 (V9) and Week 12 (V10)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05220410, which also lists 1 linked publication.
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 24 Dec 2025.