drugset / Trial / NCT01588457
Sequential Multiple Assignment Treatment for Bipolar Disorder
Phase 4
Completed
112 enrolled
The University of Texas Health Science Center at San Antonio
National Institute of Mental Health (NIMH) · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to compare which of the two mood stabilizers (drugs that help to steady/stabilize mood in patients with bipolar disorder (BD)), lithium and divalproex, is more effective in patients with bipolar disorder over 26 weeks. The study will also compare if lithium or divalproex used alone versus lithium or divalproex used with quetiapine versus lithium or divalproex used with lamotrigine is more effective when symptoms of depression develop.
Timeline
- Start
- 2011-06
- Primary completion
- 2016-12
- Completion
- 2016-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Divalproex Sodium | Small molecule | — | — |
| Comparator | Lamotrigine | Small molecule | 200 mg | — |
| Comparator | Lamotrigine | Small molecule | 400 mg | — |
| Comparator | Lithium | Unknown | — | — |
| Comparator | Quetiapine | Small molecule | 300 mg | — |