Sequential Multiple Assignment Randomized Trial for Bipolar Depression
Public ClinicalTrials.gov record NCT06433635. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a sequential multiple assignment randomized trial for adults (ages \> 18) with a bipolar disorder type 1 and type 2 diagnosis currently experiencing a depressive episode. It is a randomized pragmatic trial that will compare four commonly prescribed treatments for bipolar depression, which includes three FDA-approved medications (Cariprazine, Quetiapine and Lurasidone) and one antipsychotic/antidepressant combination (Aripiprazole/Escitalopram).
Study identification
- NCT ID
- NCT06433635
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 2,726 participants
Conditions and interventions
Conditions
Interventions
- Cariprazine Drug
- Aripiprazole/Escitalopram combination Drug
- Quetiapine Drug
- Lurasidone Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 1, 2024 (Actual)
- Primary completion
- Feb 28, 2030 (Estimated)
- Completion
- Feb 28, 2030 (Estimated)
- Last update posted
- Dec 16, 2025
2024 – 2030
United States locations
- U.S. sites
- 17
- U.S. states
- 11
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama Birmingham | Birmingham | Alabama | 35294 | — |
| Steve Strakowski | Bloomington | Indiana | 47405 | — |
| John Hopkins | Baltimore | Maryland | 21218 | — |
| McLean Hospital | Belmont | Massachusetts | 02478 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| University of Michigan | Ann Arbor | Michigan | 48109 | — |
| Nagy Youssef | Grand Rapids | Michigan | 49548 | — |
| University of New Mexico Health Sciences Center Albuquerque | Albuquerque | New Mexico | 87131-0001 | — |
| New York University Grossman School of Medicine NYU | New York | New York | 10016 | — |
| Montefiore Medical Center and Albert Einstein College of Medicine | New York | New York | 10461 | — |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | — |
| Case Western Reserve University | Cleveland | Ohio | 44106-1712 | — |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15260 | — |
| University of Texas at Austin | Austin | Texas | 78712 | — |
| UT Southwestern Medical Center | Dallas | Texas | 75390-7208 | — |
| UT Health Houston Texas | Houston | Texas | 77030 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06433635, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 16, 2025 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06433635 live on ClinicalTrials.gov.