drugset / Trial / NCT02389712

16-week Comparative Effectiveness Trial of Lamotrigine vs. Fluoxetine for Bipolar Depression

NCT02389712

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

EvaluationDrugModalityDoseRoute
Comparator Fluoxetine Small molecule 60 mg
Comparator Lamotrigine Small molecule 200 mg

Indications