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Sequential Multiple Assignment Randomized Trial for Bipolar Depression
NCT06433635 · View on ClinicalTrials.gov ↗
Study Summary
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).
Conditions Studied
Interventions
- DRUG Quetiapine
- DRUG Cariprazine
- DRUG Aripiprazole/Escitalopram combination
- DRUG Lurasidone
Study Locations (18)
Texas
- University of Texas at Austin — Austin
- UT Southwestern Medical Center — Dallas
- UT Health Houston Texas — Houston
Massachusetts
- McLean Hospital — Belmont
- Massachusetts General Hospital — Boston
Michigan
- University of Michigan — Ann Arbor
- Nagy Youssef — Grand Rapids
New York
- New York University Grossman School of Medicine NYU — New York
- Montefiore Medical Center and Albert Einstein College of Medicine — New York
Pennsylvania
- University of Pennsylvania — Philadelphia
- University of Pittsburgh — Pittsburgh
Alabama
- University of Alabama Birmingham — Birmingham
Indiana
- Steve Strakowski — Bloomington
Maryland
- John Hopkins — Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,726 participants |
| Start Date | 2024-10-01 |
| Est. Completion | 2030-02-28 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06433635
The ClinicalTrials.gov registry entry for NCT06433635 describes a study currently listed as active not recruiting. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 2,726 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Massachusetts General Hospital, which has 1,948 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Depression appearing as the primary indexed condition, and to 4 interventions — of which Quetiapine is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06433635 reports 18 study locations spanning 12 distinct geographic areas — top geographies include Texas, Massachusetts, Michigan. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06433635 about?
NCT06433635 is a clinical study titled "Sequential Multiple Assignment Randomized Trial for Bipolar Depression". 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 in...
What is the current status of trial NCT06433635?
This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 2,726 participants. The study started on 2024-10-01. Estimated completion is 2030-02-28.
What conditions does trial NCT06433635 study?
This clinical trial studies the following conditions: Depression, Bipolar I Disorder. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06433635?
The interventions under investigation include: Quetiapine (DRUG), Cariprazine (DRUG), Aripiprazole/Escitalopram combination (DRUG), Lurasidone (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06433635?
This trial is sponsored by Massachusetts General Hospital, which has 1,948 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06433635 being conducted?
This trial has 18 study locations across Alabama, Indiana, Maryland, Massachusetts, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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