The Evaluation of LAMICTAL™ as an Add-on Treatment for Bipolar I Disorder in Children and Adolescents, 10 to 17 Years of Age

Overview

The purpose of this study is to investigate the effects of the medication Lamictal on pediatric bipolar I patients compared to a placebo. This study has been proposed to evaluate the effectiveness, safety, and tolerability of Lamictal as add-on therapy in children and adolescent subjects with bipolar I disorder who continue to be symptomatic on conventional mood stabilizer or antipsychotic treatment. Lamictal was approved in June 2003 for the maintenance therapy of bipolar I disorder to delay the time to occurrence of mood episodes in adult patients treated for acute mood episodes with standard therapy. The Food and Drug Administration (FDA) has requested that GlaxoSmithKline (GSK) investigate the effects of Lamictal in children and adolescents with bipolar disorder.

Children and adolescents who are 10 to 17 years of age, and have been diagnosed with bipolar I disorder, may be eligible for participation. The study consists of 4 phases: a Screen Phase (approximately 2 weeks), an Open-label Phase (up to 18 weeks), a Randomized Phase (up to 36 weeks), and a Taper and Follow-up Phase (2 to 4 weeks), which is either open-label or double-blind depending on the phase of the study. Each patient will be assigned at random to either the placebo group (no medication) or the Lamictal group (medication). Neither you nor the study staff will know whether you are receiving the investigational medication or the placebo until the end of the study, but the study doctor can find out earlier if it becomes necessary when looking after your health.

All study-related procedures, and any study medication (lamictal or placebo capsules) will be provided at no cost to you.

Eligibility

• Diagnosed with Bipolar I and currently taking a conventional bipolar medication
• Between the ages of 10 and 17
• Have a history of at least 1 bipolar manic or mixed episode
• Not currently pregnant and no intention to become pregnant during study period
• No major, untreated medical illnesses (i.e., heart or kidney disease, neurologic disorders, thyroid abnormality, hepatitis)
• No history of seizures
• No use of unapproved or concomitant medications during the study
• Other criteria may apply and will be assessed during the screening phase of the study

Compensation

You will be paid $44.65 for each visit, totaling $1,919.95 if all visits are completed.