Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06433635 · ClinicalTrials.gov registry record · Phase 4
Sequential Multiple Assignment Randomized Trial for Bipolar Depression
A Phase 4 study of Depression and Bipolar I Disorder, sponsored by Massachusetts General Hospital.
- Active
- Registry status
- Phase 4
- Development phase
- 2,726
- Enrollment target
- 18
- Study locations
NCT06433635 is a Phase 4 study of Depression and Bipolar I Disorder that is active but no longer recruiting, run by Massachusetts General Hospital. The registered enrollment target is 2,726 participants, above the 782-participant average among 679 other Depression trials with a reported enrollment target (249% higher). The trial reports 18 study locations across 12 states.
The verdict
NCT06433635, a Phase 4 study of Depression and Bipolar I Disorder, is active but no longer recruiting, sponsored by Massachusetts General Hospital.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 4
- Development phase
- 2,726 participants
- Enrollment target
- 18
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 4. The registered enrollment target is 2,726 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 782-participant average among 679 other Depression trials with a reported enrollment target (249% higher). The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.
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.
NCT06433635 reports 18 study locations spanning 12 distinct geographic areas - top geographies include Texas, Massachusetts, Michigan.
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.
What interventions are being tested in trial NCT06433635?
The interventions under investigation include: Quetiapine (DRUG), Cariprazine (DRUG), Aripiprazole/Escitalopram combination (DRUG), Lurasidone (DRUG).
Who is sponsoring clinical trial NCT06433635?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Depression
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Identifying and Treating Depression in the Orthopaedic Trauma Population
RECRUITING · Phase 4
-
Dopaminergic Therapy for Anhedonia - 2
RECRUITING · Phase 4
-
Examining the Effects of Estradiol on Neural and Molecular Response to Reward
RECRUITING · Phase 4
-
Buspirone and Melatonin for Depression Following Traumatic Brain Injury
RECRUITING · Phase 4
-
Processes and Circuitry Underlying Threat Sensitivity as a Treatment Target for Co-morbid Anxiety and Depression
RECRUITING · Phase 4
-
Determining Optimal Treatment Sequences in Anxious Depression (DOTS-AD)
RECRUITING · Phase 4
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.