drugset / Trial / NCT02389712
16-week Comparative Effectiveness Trial of Lamotrigine vs. Fluoxetine for Bipolar Depression
RandomizedParallel-groupOpen-labelTreatment
Summary
The FLAME Study is a 16-week clinical trial to study treatment with lamotrigine or fluoxetine in bipolar I, II and bipolar schizoaffective depressed adults. The purpose of the trial is to have a better understanding of whether individuals with a particular gene type and other inherited biological markers will have a good response to fluoxetine or lamotrigine, or alternatively, would be more likely to have side effects to this medication.
Timeline
- Start
- 2015-03
- Primary completion
- 2018-05-23
- Completion
- 2018-05-23
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Fluoxetine | Small molecule | 60 mg | — |
| Comparator | Lamotrigine | Small molecule | 200 mg | — |