Sequential Multiple Assignment Randomized Trial for Bipolar Depression

Status: Recruiting
Location: See all (17) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

This is a sequential multiple assignment randomized trial for adults (ages \> 18) with a bipolar disorder type 1 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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Aged between 18 years to 75 years

• Meets criteria for DSM-V Bipolar I disorder with a history of manic episodes and current major depressive episode lasting at least 6 weeks

• Can be managed as an outpatient and participate in the study

• Willing to be randomized; able to perform study assessments

• Women of childbearing potential must agree to use adequate contraception (e.g. oral contraceptives, intrauterine device, barrier methods, or total abstinence; Depo Provera is acceptable if it is started 3 months prior to enrollment), and inform staff of their plans to conceive.

Locations
United States
Alabama
University of Alabama Birmingham
NOT_YET_RECRUITING
Birmingham
Indiana
Steve Strakowski
NOT_YET_RECRUITING
Bloomington
Massachusetts
McLean Hospital
RECRUITING
Belmont
Massachusetts General Hospital
RECRUITING
Boston
Maryland
John Hopkins
NOT_YET_RECRUITING
Baltimore
Michigan
University of Michigan
RECRUITING
Ann Arbor
North Carolina
University of North Carolina at Chapel Hill
RECRUITING
Chapel Hill
New Mexico
University of New Mexico Health Sciences Center Albuquerque
NOT_YET_RECRUITING
Albuquerque
New York
Montefiore Medical Center and Albert Einstein College of Medicine
RECRUITING
New York
New York University Grossman School of Medicine NYU
NOT_YET_RECRUITING
New York
Ohio
Case Western Reserve University
NOT_YET_RECRUITING
Cleveland
Pennsylvania
University of Pennsylvania
NOT_YET_RECRUITING
Philadelphia
University of Pittsburgh
NOT_YET_RECRUITING
Pittsburgh
Texas
University of Texas at Austin
RECRUITING
Austin
UT Southwestern Medical Center
RECRUITING
Dallas
UT Health Houston Texas
RECRUITING
Houston
Other Locations
Canada
University of British Columbia
NOT_YET_RECRUITING
Vancouver
Contact Information
Primary
Andrew Nierenberg, M.D
anierenberg@mgh.harvard.edu
617-724-0837
Time Frame
Start Date: 2024-10-01
Estimated Completion Date: 2030-02-28
Participants
Target number of participants: 2726
Treatments
Experimental: Cariprazine
Experimental: Aripiprazole /Escitalopram combination
Experimental: Quetiapine
Experimental: Lurasidone
Sponsors
Leads: Massachusetts General Hospital
Collaborators: Patient-Centered Outcomes Research Institute

This content was sourced from clinicaltrials.gov