drugset / Trial / NCT00176228

Lamotrigine Monotherapy in Pediatric Bipolar Disorder

NCT00176228

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

EvaluationDrugModalityDoseRoute
Subject Lamotrigine Small molecule 150 mg
Subject Lamotrigine Small molecule 200 mg
Subject Lamotrigine Small molecule 400 mg

Indications