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: Active Phase 4 study of Depression and Bipolar I Disorder, sponsored by Massachusetts General Hospital.
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. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
RDQ is a 41 items self report questionnaire used to assess the seven domains found in extensive previous research to be important to patients: depressive symptoms, anxiety, coping ability, positive mental health, functioning, life satisfaction and a general sense of well-being. Using a score of 27 as the cutoff, the RDQ scale has a sensitivity of 83.7% and specificity of 77.9% in predicting self-reported remission status. The RDQ has excellent internal consistency reliability (Cronbach's alpha o
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 |
What the registry record for NCT06433635 still lists
NCT06433635 is an interventional study that assigns participants to a tested intervention. Its 2,726 participants enrollment target places it among the larger protocols in the corpus, above the 782-participant average among 679 other Depression trials with a reported enrollment target (249% higher).
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 lists 18 locations in 12 states (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.
Where NCT06433635's enrollment target sits among peer trials
2,726 20th of 679 higher than 660 of 679 other Depression trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Depression trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT06085833 · 2,706 participants · NA
ARTIDIS Nanomechanical Generated Measurements for Early Breast Lesions
- NCT04073420 · 2,700 participants
Medtronic Cardiac Surgery PMCF Registry
- NCT05125939 · 2,700 participants
Can Overall Adenoma Detection Rate Replace Screening Adenoma Detection Rate ? Multicenter Study
- NCT05586776 · 2,700 participants · Phase 4
Decolonization to Reduce After-Surgery Events of Surgical Site Infection
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT06358040 · started 2026-10 · NA
Opioid Dispenser for Microdiscectomy/Laminectomy