Sequential Multiple Assignment Randomized Trial for Bipolar Depression
United States2,726 participantsStarted 2024-10-01
Plain-language 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).
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Aged between 18 years to 75 years
✓. 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
✓. 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.
Exclusion criteria
✕. Meets current criteria for a manic episode, rapid cycling within the past year (history of 4 or more mood episodes per year)
✕. History of schizophrenia or other nonaffective psychosis
✕. Current substance use disorder that will interfere with participation in the study
✕. 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
✕. A history of non-response for depressive episodes, to any of the study medications, when given at adequate doses for at least 6 weeks
✕. Current acute suicidal risk that requires inpatient treatment
What they're measuring
1
The Remission from Depression Questionnaire
Timeframe: Investigators will administer this measure every 2 weeks for the first 12 weeks (weeks:0,2,4,6,8,10,12), and then at each study visit during the follow up phase until they are discharged from the study (weeks:20,28,36,44,52 ).