Treatment Resistant DepressionPhase 2NCT04433845
The Safety and Efficacy of Psilocybin in Participants With Type 2 Bipolar Disorder (BP-II) Depression.
A Phase 2 study testing Psilocybin in people with Treatment Resistant Depression, run by Sheppard Pratt Health System at 1 site in United States.
Trial summary
The primary objective of this study is to evaluate the efficacy of 25 mg of psilocybin under supportive conditions to adult participants with BP-II, current episode depressed, in improving depressive symptoms. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Treatment Resistant Depression
- What is being tested?
- Psilocybin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2021to 15 Apr 2023
- 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
- Diagnosis of Type 2 Bipolar Disorder (BP-II) Depression
Who cannot join
- Comorbidities
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective of this study is to evaluate the efficacy of 25 mg of psilocybin under supportive conditions to adult participants with BP-II, current episode depressed, in improving depressive symptoms.
- Conditions
- Treatment Resistant Depression
- Being tested
- Psilocybin
- Medical subject headings
- Depressive Disorder, Treatment-Resistant
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.
Montgomery-Asberg Depression Rating Scale (MADRS)
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. Response = >50% decrease and Remission =< 10 actual score
Measured: From Baseline (Day -1) to three weeks post-dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start1 Mar 2021
- Primary completion15 Jan 2023 (estimated)
- Study completion15 Apr 2023 (estimated)
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
- 15 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
- NCT04433845
- Sponsor's protocol ID
- 14947483
- Status last verified
- Oct 2022
- First submitted
- 13 Jun 2020
- Last updated
- 25 Oct 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aaronson ST, van der Vaart A, Miller T, LaPratt J, Swartz K, Shoultz A, Lauterbach M, Sackeim HA, Suppes T. Single-Dose Synthetic Psilocybin With Psychotherapy for Treatment-Resistant Bipolar Type II Major Depressive Episodes: A Nonrandomized Open-Label Trial. JAMA Psychiatry. 2024 Jun 1;81(6):555-562. doi: 10.1001/jamapsychiatry.2023.4685.
PubMed 38055270
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy of Psilocybin in Participants With Type 2 Bipolar Disorder (BP-II) Depression.
- ClinicalTrials.gov ID
- NCT04433845
- Acronym / sponsor ID
- 14947483
- Conditions
- Treatment Resistant Depression
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Sheppard Pratt Health SystemUniversity, hospital or other
- Collaborators
- COMPASS Pathways
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 15 Jan 2023 (estimated)
- Study completion
- 15 Apr 2023 (estimated)
- First posted
- 16 Jun 2020 (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 primary objective of this study is to evaluate the efficacy of 25 mg of psilocybin under supportive conditions to adult participants with BP-II, current episode depressed, in improving depressive symptoms.
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 (1 listed)
- Diagnosis of Type 2 Bipolar Disorder (BP-II) Depression
Key exclusion criteria (1 listed)
- Comorbidities
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
Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: From Baseline (Day -1) to three weeks post-dose.
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. Response = >50% decrease and Remission =< 10 actual score
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2022.
- Derived from this study: PubMed 38055270Aaronson ST, van der Vaart A, Miller T, LaPratt J, Swartz K, Shoultz A, Lauterbach M, Sackeim HA, Suppes T. Single-Dose Synthetic Psilocybin With Psychotherapy for Treatment-Resistant Bipolar Type II Major Depressive Episodes: A Nonrandomized Open-Label Trial. JAMA Psychiatry. 2024 Jun 1;81(6):555-562. doi: 10.1001/jamapsychiatry.2023.4685.
- 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, 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 25 Oct 2022. 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?
Results are not available in the source record.
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?
Montgomery-Asberg Depression Rating Scale (MADRS) (time frame: From Baseline (Day -1) to three weeks post-dose.). 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 NCT04433845, 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 25 Oct 2022.