ACTIVE_NOT_RECRUITING

Sequential Multiple Assignment Randomized Trial for Bipolar Depression

Conditions

Bipolar I Disorder Depression Bipolar Adults Medication

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

Sequential Multiple Assignment Randomized Trial for Bipolar Depression

Quick Facts

Study Start:2024-10-01

Study Completion:2030-02-28

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06433635

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.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Aged between 18 years to 75 years 2. Meets criteria for DSM-V Bipolar I or II disorder with a history of manic or hypomanic episodes and current major depressive episode lasting at least 2 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

Inclusion Criteria

Exclusion Criteria

1. Aged between 18 years to 75 years
2. Meets criteria for DSM-V Bipolar I or II disorder with a history of manic or hypomanic episodes and current major depressive episode lasting at least 2 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

Contacts and Locations

Study Locations (Sites)

University of Alabama Birmingham

Birmingham, Alabama, 35294

United States

Steve Strakowski

Bloomington, Indiana, 47405

United States

John Hopkins

Baltimore, Maryland, 21218

United States

McLean Hospital

Belmont, Massachusetts, 02478

United States

Massachusetts General Hospital

Boston, Massachusetts, 02114

United States

University of Michigan

Ann Arbor, Michigan, 48109

United States

Nagy Youssef

Grand Rapids, Michigan, 49548

United States

University of New Mexico Health Sciences Center Albuquerque

Albuquerque, New Mexico, 87131-0001

United States

New York University Grossman School of Medicine NYU

New York, New York, 10016

United States

Montefiore Medical Center and Albert Einstein College of Medicine

New York, New York, 10461

United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599

United States

Case Western Reserve University

Cleveland, Ohio, 44106-1712

United States

University of Pennsylvania

Philadelphia, Pennsylvania, 19104

United States

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260

United States

University of Texas at Austin

Austin, Texas, 78712

United States

UT Southwestern Medical Center

Dallas, Texas, 75390-7208

United States

UT Health Houston Texas

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-01

Study Completion Date2030-02-28

Study Record Updates

Study Start Date2024-10-01

Study Completion Date2030-02-28

Terms related to this study

Keywords Provided by Researchers

Bipolar
Depression
Adults
Medication

Additional Relevant MeSH Terms

Bipolar I Disorder
Depression