Comparing treatments for bipolar depression in adults
Sequential Multiple Assignment Randomized Trial for Bipolar Depression
This study is testing four different treatments for adults with Bipolar I Disorder who are dealing with a major depressive episode to see which one works best over a year.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 2726 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 17 sites (Birmingham, Alabama and 16 other locations) |
| Trial ID | NCT06433635 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the effectiveness of four treatments for adults with Bipolar I Disorder experiencing a major depressive episode. It employs a Sequential Multiple Assignment Randomized Trial (SMART) design, allowing for re-randomization of participants who do not respond to initial treatments. The study will recruit 2726 participants across multiple sites and follow them for 52 weeks to assess treatment outcomes. The interventions include three FDA-approved medications and a combination therapy that is commonly used but not FDA-approved.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with a diagnosis of Bipolar I Disorder currently experiencing a major depressive episode.
Not a fit: Patients currently experiencing a manic episode or those with a history of rapid cycling or nonaffective psychosis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could identify the most effective treatment options for managing bipolar depression, improving patient outcomes.
How similar studies have performed: Other studies have shown promise in comparing treatment effectiveness for bipolar depression, but this specific approach using a SMART design is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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. Exclusion Criteria: 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
Where this trial is running
Birmingham, Alabama and 16 other locations
- University of Alabama Birmingham — Birmingham, Alabama, United States (Not_yet_recruiting)
- Steve Strakowski — Bloomington, Indiana, United States (Not_yet_recruiting)
- John Hopkins — Baltimore, Maryland, United States (Not_yet_recruiting)
- McLean Hospital — Belmont, Massachusetts, United States (Recruiting)
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
- University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
- University of New Mexico Health Sciences Center Albuquerque — Albuquerque, New Mexico, United States (Not_yet_recruiting)
- New York University Grossman School of Medicine NYU — New York, New York, United States (Not_yet_recruiting)
- Montefiore Medical Center and Albert Einstein College of Medicine — New York, New York, United States (Recruiting)
- University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (Recruiting)
- Case Western Reserve University — Cleveland, Ohio, United States (Not_yet_recruiting)
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (Not_yet_recruiting)
- University of Pittsburgh — Pittsburgh, Pennsylvania, United States (Not_yet_recruiting)
- University of Texas at Austin — Austin, Texas, United States (Recruiting)
- UT Southwestern Medical Center — Dallas, Texas, United States (Recruiting)
- UT Health Houston Texas — Houston, Texas, United States (Recruiting)
- University of British Columbia — Vancouver, British Columbia, Canada (Not_yet_recruiting)
Study contacts
- Study coordinator: Andrew Nierenberg, M.D
- Email: anierenberg@mgh.harvard.edu
- Phone: 617-724-0837
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.