drugset / Trial / NCT06433635
Sequential Multiple Assignment Randomized Trial for Bipolar Depression
Phase 4
Active not recruiting
2726 enrolled
Massachusetts General Hospital
Patient-Centered Outcomes Research Institute · collab
RandomizedSequentialOpen-labelTreatment
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).
Timeline
- Start
- 2024-10-01
- Primary completion
- 2030-02-28
- Completion
- 2030-02-28
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aripiprazole | Other / unclassified | — | — |
| Subject | Cariprazine | Small molecule | — | — |
| Subject | Escitalopram | Small molecule | — | — |
| Subject | Lurasidone | Small molecule | — | — |
| Subject | Quetiapine | Small molecule | — | — |