Bipolar II DisorderPhase 2BAPNCT05065294
Psilocybin Therapy for Depression in Bipolar II Disorder
A Phase 2 study testing Psilocybin therapy in people with Bipolar II Disorder, run by University of California, San Francisco at 1 site in United States.
Trial summary
The purpose of this study is to determine the safety, tolerability, and feasibility of psilocybin therapy in people with Bipolar II Disorder. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Bipolar II Disorder
- What is being tested?
- Psilocybin therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jan 2022to Jul 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 70
- Comfortable speaking and writing in English
- Diagnosis of Bipolar Disorder II with current depression
- Have a care partner/support person available throughout the study
- Able to attend all in-person visits at UCSF as well as virtual visits
- Having tried at least one previous medication trials for their bipolar disorder, each lasting at 6 weeks or more.
Who cannot join
- Current or previous diagnosis of Bipolar I Disorder
- History of schizophrenia spectrum or psychotic disorder
- Use of psychedelics within the past 6 months, including MDMA
- Current diagnosis of cancer
- Seizures that continue to the present
- Fear of blood or needles
- Regular use of medications that may have problematic interactions with psilocybin, including but not limited to antidepressants (Bupropion allowed), serotonin antagonists, some antipsychotics, dopamine agonists/antagonists, stimulants, opioids, and Lithium.
- A health condition that makes this study unsafe or unfeasible, determined by study physicians
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94121
About this study
Official title: An Open-Label Pilot Study Examining the Feasibility, Safety, and Effectiveness of Psilocybin Therapy for Depression in Bipolar II Disorder
The purpose of this study is to determine the safety, tolerability, and feasibility of psilocybin therapy in people with Bipolar II Disorder.
Read the detailed description
The primary goal of this study is to examine the safety, tolerability, and feasibility of psilocybin therapy in people with Bipolar II Disorder (BD II). Fourteen participants, ages 18 to 70 with clinically diagnosed BD II with active depression, in active outpatient mental health treatment, and who meet all other inclusion and exclusion criteria at screening will be enrolled. After baseline assessments, participants will engage in preparatory visits with trained facilitators, followed by an initial drug administration of oral psilocybin,supervised by the facilitators and a clinician who will conduct safety monitoring throughout. Participants will complete assessment and integration sessions with the facilitators subsequently in order to help process the experience. Participants who tolerated the first dosage may be asked to complete a second psilocybin dosing session, involving the same preparation, procedures, integration, and supervision as the first. Primary outcome measures will assess safety, tolerability, and feasibility of study procedures. Efficacy will be measured by change in depression as measured by the MADRS three weeks after the final psilocybin administration. Exploratory outcome measures will assess changes in sleep, quality of life, and therapeutic engagement.
- Conditions
- Bipolar II Disorder
- Being tested
- Psilocybin therapy
- Keywords
- Bipolar, Depression, Psilocybin, Psychedelic, Psilocybin Therapy, Bipolar II, Safety
- Medical subject headings
- Bipolar Disorder, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psilocybin therapyDrug
Also called 4-phosphoryloxy-N,N-dimethyltryptamine
- Psilocybin administration session 10mg-25mg delivered orally with psychological support and monitoring
| Study group | Role | What they receive |
|---|---|---|
| Psilocybin therapy | Experimental | Participants will receive one or two doses of psilocybin in a monitored setting approximately three weeks apart, with preparation sessions before and integration sessions after. Receives: Drug: Psilocybin therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of psilocybin therapy for depression in BD II
-Incidence, severity, and frequency of Adverse Events (AEs) including Treatment-Emergent AEs (TEAEs) and Serious AEs (SAEs)
Measured: Baseline to 3 months following last drug dose
Recruitment rate
-Measured as a percentage of participants who were contacted for pre-screening and consented.
Measured: Baseline to 3 months following last drug dose
Retention rate
-Measured as a percentage of participants who began and completed treatment.
Measured: Baseline to 3 months following last drug dose
Clinician-reported effects of psilocybin therapy on depressive symptoms in people with Bipolar II
- Montgomery-Asberg Depression Rating Scale (MADRS)
- Each item is scored on a on a scale of 0-6 with a total score of 0-60
- Higher scores correspond to worse outcomes
Measured: Baseline to 3 weeks following last drug dose
Treatment Satisfaction of study procedures
- Measured by the treatment satisfaction questionnaire
- 5-item scale, plus three free response questions
- Higher scores representing better treatment satisfaction
Measured: Baseline to 3 months following last drug dose
Self-reported effects of psilocybin therapy on manic and/or psychotic symptoms in people with Bipolar II
- Altman Self-Rating Mania Scale(ASRM-14)
- Each item rated on a 0 to 4 scale, with a total score of 0 to 56
- Higher scores indicating greater severity of manic symptoms, with items that also measure psychosis
Measured: Baseline to 11 days following each drug dose
Clinician-reported effects of psilocybin therapy on mania symptoms in people with Bipolar II
- Young Mania Scale(YMS)
- 7 items are rated on a 0 to 4 scale and 4 items are rated on a 0 to 8 scale. The total score ranges from 0-60
- Higher scores indicating greater severity of manic symptoms.
Measured: Baseline to 3 months following each drug dose
Clinician-reported effects of psilocybin therapy on suicidality symptoms in people with Bipolar II
- Columbia-Suicide Severity Rating Scale (C-SSRS)
- Characterizes suicidal ideation in three separate categories with a total score range from 0-25
- Higher scores indicate greater severity
Measured: Baseline to 3 months following last drug dose
Secondary outcomes (9)
Patient reported effects of psilocybin therapy on depressive symptoms symptoms in people with Bipolar II (exploratory)
- Quick Inventory of Depressive Symptomatology (QIDS-SR)
- Each item is scored on a on a scale of 0-3, with a total score of 0-27
- Higher scores correspond to worse outcomes
Measured: Baseline to 3 months following last drug dose
Effects of psilocybin therapy on anxiety symptoms in people with Bipolar II (exploratory)
- Generalized Anxiety Disorder 7-item scale (GAD-7)
- Each item is rated on a scale from 0-3, with a total score of 0-21
- Higher scores correspond to worse outcomes
Measured: Baseline to 3 months following last drug dose
Effects of psilocybin therapy on sleep quality in people with Bipolar II (exploratory)
- Insomnia Severity Index (ISI)
- Each item is scored on a scale of 0-4 with a total score range of 0-28
- Higher scores indicate greater severity in sleep disturbance
Measured: Baseline to 3 months following last drug dose
Effects of psilocybin therapy on quality of life in people with Bipolar II (exploratory)
- Quality of Life in Bipolar Disorder Questionnaire (QoL-BD)
- Each item is scored on a scale of 1-5 with a total score range of 48-240
- Higher scores indicate greater quality of life
Measured: Baseline to 3 months following last drug dose
Effects of psilocybin therapy on borderline personality disorder symptoms in people with Bipolar II (exploratory)
- Zanarini Rating Scale (ZRS)
- Each item is scored on a scale of 0-4 with a total score range of 0-30
- Higher scores indicate greater severity in symptoms
Measured: Baseline to 3 months following last drug dose
Effects of psilocybin therapy on adult attachment in people with Bipolar II (exploratory)
- Experiences in Close Relationships-Modified 16-Item Scale (ECR-M16)
- Each item is scored on a scale of 1-7 with a total score range of 8-126
- Lower scores on each dimension of attachment anxiety and avoidance represent greater levels of attachment security
Measured: Baseline to 3 months following last drug dose
Effects of psilocybin therapy on participant-reported recovery in people with Bipolar II (exploratory)
- Bipolar Recovery Questionnaire (BRQ)
- 36 items (visual analog scales)
- Higher total scores indicate a higher degree
Measured: Baseline to 3 months following last drug dose
Subjective effects of psilocybin therapy in people with Bipolar II
- 5-Dimensional Altered States of Consciousness Rating Scale (5D-ASC)
- 94 items (visual analog scales) broken down into subcategories to quantify the acute subjective effects of psilocybin directly following each psilocybin administration session
Measured: Baseline to 3 months following last drug dose
Subjective effects of psilocybin therapy in people with Bipolar II
- Study specific Transformational Experiences Questionnaire (TEQ)
- Meant to quantify subjective effects of psilocybin on 1-7 scale
Measured: 3 weeks following last drug dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2021
- Study start28 Jan 2022
- Primary completion1 Aug 2024
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Bipolar II DisorderStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open-label, single-arm, pilot study
- Masking
- None (open label)
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joshua Woolley, MD, PhD, University of California, San Francisco
- Investigators
- Joshua D Woolley, MD,PhD, Principal investigator, University of California, San FranciscoDavid Guard, PhD, Study director, San Francisco State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05065294
- Sponsor's protocol ID
- 20-32789
- Acronym
- BAP
- Status last verified
- Sep 2024
- First submitted
- 14 Sep 2021
- Last updated
- 25 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Grande I, Berk M, Birmaher B, Vieta E. Bipolar disorder. Lancet. 2016 Apr 9;387(10027):1561-1572. doi: 10.1016/S0140-6736(15)00241-X. Epub 2015 Sep 18.
PubMed 26388529Carhart-Harris RL, Bolstridge M, Rucker J, Day CM, Erritzoe D, Kaelen M, Bloomfield M, Rickard JA, Forbes B, Feilding A, Taylor D, Pilling S, Curran VH, Nutt DJ. Psilocybin with psychological support for treatment-resistant depression: an open-label feasibility study. Lancet Psychiatry. 2016 Jul;3(7):619-27. doi: 10.1016/S2215-0366(16)30065-7. Epub 2016 May 17.
PubMed 27210031Carhart-Harris RL, Bolstridge M, Day CMJ, Rucker J, Watts R, Erritzoe DE, Kaelen M, Giribaldi B, Bloomfield M, Pilling S, Rickard JA, Forbes B, Feilding A, Taylor D, Curran HV, Nutt DJ. Psilocybin with psychological support for treatment-resistant depression: six-month follow-up. Psychopharmacology (Berl). 2018 Feb;235(2):399-408. doi: 10.1007/s00213-017-4771-x. Epub 2017 Nov 8.
PubMed 29119217Griffiths RR, Johnson MW, Carducci MA, Umbricht A, Richards WA, Richards BD, Cosimano MP, Klinedinst MA. Psilocybin produces substantial and sustained decreases in depression and anxiety in patients with life-threatening cancer: A randomized double-blind trial. J Psychopharmacol. 2016 Dec;30(12):1181-1197. doi: 10.1177/0269881116675513.
PubMed 27909165Szmulewicz AG, Angriman F, Samame C, Ferraris A, Vigo D, Strejilevich SA. Dopaminergic agents in the treatment of bipolar depression: a systematic review and meta-analysis. Acta Psychiatr Scand. 2017 Jun;135(6):527-538. doi: 10.1111/acps.12712. Epub 2017 Mar 3.
PubMed 28256707Downey AE, Szigeti B, Bradley ER, Fernandes-Osterhold G, Sakai K, Llerena K, Fredenburg L, Nerayo J, Evans-Riera L, Nielsen B, Krystal AD, O'Donovan A, Gard DE, Woolley JD. An Open-Label, Dose-Escalation Trial of Psilocybin-Assisted Therapy for Bipolar II Depression. J Clin Psychiatry. 2026 Sep 21;87(4):25m16227. doi: 10.4088/JCP.25m16227.
PubMed 42765891
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Pilot Study Examining the Feasibility, Safety, and Effectiveness of Psilocybin Therapy for Depression in Bipolar II Disorder
- ClinicalTrials.gov ID
- NCT05065294
- Acronym / sponsor ID
- BAP / 20-32789
- Conditions
- Bipolar II Disorder
- Keywords
- Bipolar, Depression, Psilocybin, Psychedelic, Psilocybin Therapy, Bipolar II, Safety
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 28 Jan 2022 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- Jul 2025 (estimated)
- First posted
- 4 Oct 2021 (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 purpose of this study is to determine the safety, tolerability, and feasibility of psilocybin therapy in people with Bipolar II Disorder.
Detailed description
The primary goal of this study is to examine the safety, tolerability, and feasibility of psilocybin therapy in people with Bipolar II Disorder (BD II). Fourteen participants, ages 18 to 70 with clinically diagnosed BD II with active depression, in active outpatient mental health treatment, and who meet all other inclusion and exclusion criteria at screening will be enrolled. After baseline assessments, participants will engage in preparatory visits with trained facilitators, followed by an initial drug administration of oral psilocybin,supervised by the facilitators and a clinician who will conduct safety monitoring throughout. Participants will complete assessment and integration sessions with the facilitators subsequently in order to help process the experience. Participants who tolerated the first dosage may be asked to complete a second psilocybin dosing session, involving the same preparation, procedures, integration, and supervision as the first. Primary outcome measures will assess safety, tolerability, and feasibility of study procedures. Efficacy will be measured by change in depression as measured by the MADRS three weeks after the final psilocybin administration. Exploratory outcome measures will assess changes in sleep, quality of life, and therapeutic engagement.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open-label, single-arm, pilot study
| Arm | Type | Receives |
|---|---|---|
| Psilocybin therapy | Experimental | Drug: Psilocybin therapyParticipants will receive one or two doses of psilocybin in a monitored setting approximately three weeks apart, with preparation sessions before and integration sessions after. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 to 70
- Comfortable speaking and writing in English
- Diagnosis of Bipolar Disorder II with current depression
- Have a care partner/support person available throughout the study
- Able to attend all in-person visits at UCSF as well as virtual visits
Key exclusion criteria (8 listed)
- Current or previous diagnosis of Bipolar I Disorder
- History of schizophrenia spectrum or psychotic disorder
- Use of psychedelics within the past 6 months, including MDMA
- Current diagnosis of cancer
- Seizures that continue to the present
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 |
|---|---|---|
| Psilocybin therapyAlso: 4-phosphoryloxy-N,N-dimethyltryptamine- Psilocybin administration session 10mg-25mg delivered orally with psychological support and monitoring | Drug | Psilocybin therapy |
Primary outcome
Safety and tolerability of psilocybin therapy for depression in BD II
Time frame: Baseline to 3 months following last drug dose
-Incidence, severity, and frequency of Adverse Events (AEs) including Treatment-Emergent AEs (TEAEs) and Serious AEs (SAEs)
Recruitment rate
Time frame: Baseline to 3 months following last drug dose
-Measured as a percentage of participants who were contacted for pre-screening and consented.
Retention rate
Time frame: Baseline to 3 months following last drug dose
-Measured as a percentage of participants who began and completed treatment.
Clinician-reported effects of psilocybin therapy on depressive symptoms in people with Bipolar II
Time frame: Baseline to 3 weeks following last drug dose
* Montgomery-Asberg Depression Rating Scale (MADRS) * Each item is scored on a on a scale of 0-6 with a total score of 0-60 * Higher scores correspond to worse outcomes
Treatment Satisfaction of study procedures
Time frame: Baseline to 3 months following last drug dose
* Measured by the treatment satisfaction questionnaire * 5-item scale, plus three free response questions * Higher scores representing better treatment satisfaction
Self-reported effects of psilocybin therapy on manic and/or psychotic symptoms in people with Bipolar II
Time frame: Baseline to 11 days following each drug dose
* Altman Self-Rating Mania Scale(ASRM-14) * Each item rated on a 0 to 4 scale, with a total score of 0 to 56 * Higher scores indicating greater severity of manic symptoms, with items that also measure psychosis
Clinician-reported effects of psilocybin therapy on mania symptoms in people with Bipolar II
Time frame: Baseline to 3 months following each drug dose
* Young Mania Scale(YMS) * 7 items are rated on a 0 to 4 scale and 4 items are rated on a 0 to 8 scale. The total score ranges from 0-60 * Higher scores indicating greater severity of manic symptoms.
Clinician-reported effects of psilocybin therapy on suicidality symptoms in people with Bipolar II
Time frame: Baseline to 3 months following last drug dose
* Columbia-Suicide Severity Rating Scale (C-SSRS) * Characterizes suicidal ideation in three separate categories with a total score range from 0-25 * Higher scores indicate greater severity
9 secondary outcomes
Patient reported effects of psilocybin therapy on depressive symptoms symptoms in people with Bipolar II (exploratory)
Time frame: Baseline to 3 months following last drug dose
Effects of psilocybin therapy on anxiety symptoms in people with Bipolar II (exploratory)
Time frame: Baseline to 3 months following last drug dose
Effects of psilocybin therapy on sleep quality in people with Bipolar II (exploratory)
Time frame: Baseline to 3 months following last drug dose
Effects of psilocybin therapy on quality of life in people with Bipolar II (exploratory)
Time frame: Baseline to 3 months following last drug dose
Effects of psilocybin therapy on borderline personality disorder symptoms in people with Bipolar II (exploratory)
Time frame: Baseline to 3 months following last drug dose
Effects of psilocybin therapy on adult attachment in people with Bipolar II (exploratory)
Time frame: Baseline to 3 months following last drug dose
Effects of psilocybin therapy on participant-reported recovery in people with Bipolar II (exploratory)
Time frame: Baseline to 3 months following last drug dose
Subjective effects of psilocybin therapy in people with Bipolar II
Time frame: Baseline to 3 months following last drug dose
Subjective effects of psilocybin therapy in people with Bipolar II
Time frame: 3 weeks following last drug dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
- Background: PubMed 26388529Grande I, Berk M, Birmaher B, Vieta E. Bipolar disorder. Lancet. 2016 Apr 9;387(10027):1561-1572. doi: 10.1016/S0140-6736(15)00241-X. Epub 2015 Sep 18.
- Background: PubMed 27210031Carhart-Harris RL, Bolstridge M, Rucker J, Day CM, Erritzoe D, Kaelen M, Bloomfield M, Rickard JA, Forbes B, Feilding A, Taylor D, Pilling S, Curran VH, Nutt DJ. Psilocybin with psychological support for treatment-resistant depression: an open-label feasibility study. Lancet Psychiatry. 2016 Jul;3(7):619-27. doi: 10.1016/S2215-0366(16)30065-7. Epub 2016 May 17.
- Background: PubMed 29119217Carhart-Harris RL, Bolstridge M, Day CMJ, Rucker J, Watts R, Erritzoe DE, Kaelen M, Giribaldi B, Bloomfield M, Pilling S, Rickard JA, Forbes B, Feilding A, Taylor D, Curran HV, Nutt DJ. Psilocybin with psychological support for treatment-resistant depression: six-month follow-up. Psychopharmacology (Berl). 2018 Feb;235(2):399-408. doi: 10.1007/s00213-017-4771-x. Epub 2017 Nov 8.
- Background: PubMed 27909165Griffiths RR, Johnson MW, Carducci MA, Umbricht A, Richards WA, Richards BD, Cosimano MP, Klinedinst MA. Psilocybin produces substantial and sustained decreases in depression and anxiety in patients with life-threatening cancer: A randomized double-blind trial. J Psychopharmacol. 2016 Dec;30(12):1181-1197. doi: 10.1177/0269881116675513.
- Background: PubMed 28256707Szmulewicz AG, Angriman F, Samame C, Ferraris A, Vigo D, Strejilevich SA. Dopaminergic agents in the treatment of bipolar depression: a systematic review and meta-analysis. Acta Psychiatr Scand. 2017 Jun;135(6):527-538. doi: 10.1111/acps.12712. Epub 2017 Mar 3.
- Derived from this study: PubMed 42765891Downey AE, Szigeti B, Bradley ER, Fernandes-Osterhold G, Sakai K, Llerena K, Fredenburg L, Nerayo J, Evans-Riera L, Nielsen B, Krystal AD, O'Donovan A, Gard DE, Woolley JD. An Open-Label, Dose-Escalation Trial of Psilocybin-Assisted Therapy for Bipolar II Depression. J Clin Psychiatry. 2026 Sep 21;87(4):25m16227. doi: 10.4088/JCP.25m16227.
- 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.
Joshua D Woolley, MD,PhD principal investigator
University of California, San Francisco
David Guard, PhD study director
San Francisco State University
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 therapy in people with Bipolar II Disorder, run by University of California, San Francisco 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 6 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 25 Sep 2024. 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?
This study is still under way. Results are not available in the source record yet.
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?
Safety and tolerability of psilocybin therapy for depression in BD II (time frame: Baseline to 3 months following last drug dose). The study lists 8 primary outcomes in all. 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 NCT05065294, which also lists 6 linked publications.
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 Sep 2024.