Multiple Medications for Bipolar Depression
(SMART-BD Trial)

Recruiting in Palo Alto (17 mi)

+17 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Massachusetts General Hospital

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing four different medications to find the best treatment for adults with bipolar disorder type 1 who are currently depressed. The medications work by balancing brain chemicals that affect mood. The goal is to help patients recover from depression and stay well.

Research Team

Eligibility Criteria

Adults over 18 with bipolar disorder type 1 who are currently in a depressive episode can join this trial. It's not specified, but typically participants need to meet certain health criteria and may be excluded for various reasons such as other medical conditions or treatments that could interfere with the study.

Inclusion Criteria

Can be managed as an outpatient and participate in the study

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.

I am between 18 and 75 years old.

See 2 more

Exclusion Criteria

Current substance use disorder that will interfere with participation in the study

Pregnancy or breastfeeding

History of schizophrenia or other nonaffective psychosis

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Treatment Details

Interventions

Aripiprazole/Escitalopram combination (Antipsychotic/Antidepressant Combination)
Cariprazine (Atypical Antipsychotic)
Lurasidone (Atypical Antipsychotic)
Quetiapine (Atypical Antipsychotic)

Trial OverviewThe trial is testing four treatments for bipolar depression: Cariprazine, Quetiapine, Lurasidone (all FDA-approved), and an Aripiprazole/Escitalopram combo. Patients will be randomly assigned to one of these treatments in sequence to see which works best.

Participant Groups

4Treatment groups

Experimental Treatment

Group I: QuetiapineExperimental Treatment1 Intervention

Group II: LurasidoneExperimental Treatment1 Intervention

Group III: CariprazineExperimental Treatment1 Intervention

Group IV: Aripiprazole /Escitalopram combinationExperimental Treatment1 Intervention