Sequential Multiple Assignment Randomized Trial for Bipolar Depression

Description

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).

Conditions

Bipolar I Disorder, Depression

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Study Overview

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Study Details

Study overview

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).

Sequential Multiple Assignment Randomized Trial for Bipolar Depression

Sequential Multiple Assignment Randomized Trial for Bipolar Depression

Condition
Bipolar I Disorder
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama Birmingham, Birmingham, Alabama, United States, 35294

Bloomington

Steve Strakowski, Bloomington, Indiana, United States, 47405

Baltimore

John Hopkins, Baltimore, Maryland, United States, 21218

Belmont

McLean Hospital, Belmont, Massachusetts, United States, 02478

Boston

Massachusetts General Hospital, Boston, Massachusetts, United States, 02114

Ann Arbor

University of Michigan, Ann Arbor, Michigan, United States, 48109

Albuquerque

University of New Mexico Health Sciences Center Albuquerque, Albuquerque, New Mexico, United States, 87131-0001

New York

New York University Grossman School of Medicine NYU, New York, New York, United States, 10016

New York

Montefiore Medical Center and Albert Einstein College of Medicine, New York, New York, United States, 10461

Chapel Hill

University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States, 27599

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Aged between 18 years to 75 years
  • 2. Meets criteria for DSM-V Bipolar I disorder with a history of manic episodes and current major depressive episode lasting at least 6 weeks
  • 3. Can be managed as an outpatient and participate in the study
  • 4. Willing to be randomized; able to perform study assessments
  • 5. 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.
  • 1. Meets current criteria for a manic episode, rapid cycling within the past year (history of 4 or more mood episodes per year)
  • 2. History of schizophrenia or other nonaffective psychosis
  • 3. Current substance use disorder that will interfere with participation in the study
  • 4. Currently taking the study medications or a history of serious adverse events to any of the study medications, to the extent that as determined by site PI, another trial would not be clinically indicated
  • 5. A history of non-response for depressive episodes, to any of the study medications, when given at adequate doses for at least 6 weeks
  • 6. Current acute suicidal risk that requires inpatient treatment
  • 7. Pregnancy or breastfeeding

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Massachusetts General Hospital,

Study Record Dates

2030-02-28