drugset / Trial / NCT00176228
Lamotrigine Monotherapy in Pediatric Bipolar Disorder
NaSingle-groupOpen-labelTreatment
Summary
There are two purposes for this project. Study 1 is intended to study the safety and efficacy of Lamotrigine in stabilizing the mood in all phases of pediatric bipolar disorder (Phases: mixed, manic, hypomanic, or depressed episodes) in 8-17 year old children. These children and adolescents must be treatment resistant (who failed on two adequate trials of mood stabilizing medications) to qualify for this study. Study 2 is aimed at examining brain activity and/or dysfunction before lamotrigine treatment, and to look for any alteration after lamotrigine treatment. Brain systems associated with attention and emotional processing will targeted.
Timeline
- Start
- 2004-02
- Primary completion
- 2008-01
- Completion
- 2008-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lamotrigine | Small molecule | 150 mg | — |
| Subject | Lamotrigine | Small molecule | 200 mg | — |
| Subject | Lamotrigine | Small molecule | 400 mg | — |