The study will be a multi-center, parallel, group, placebo control, double-blind, randomized
controlled trial of lamictal as add-on maintenance treatment in pediatric outpatients (aged
10 to 17 years) diagnosed with Bipolar I disorder. The study consists of 4 phases: Screen
(approximately 2 weeks), Open label phase (up to 18 weeks), Randomized phase (up to 36
weeks) and Taper and follow-up phase (up to 4 weeks).
Inclusion Criteria
1. Subject is male or female between the ages of 10 and 17 years, inclusive.
2. Subject has a diagnosis of bipolar I disorder and is currently experiencing a
manic/hypomanic, depressed, or mixed mood episode
3. Subject is currently receiving a stable treatment regimen.
4. Subject is living with his/her custodial parent(s) or legal guardian(s) and has
contact with them on a daily basis.
Exclusion Criteria
1. Subject has been diagnosed with a primary Axis I disorder (with the exception of
bipolar I disorder, ADHD, anxiety disorders, oppositional defiant disorder, or
conduct disorder) or any Axis II disorder.
2. Subject currently has signs or symptoms of psychosis or a history of psychosis within
the previous four weeks.
3. Subject has been diagnosed with epilepsy, autism, Asperger's syndrome, or Tourette's
syndrome.
4. Subject has experienced a serious rash, such as Stevens-Johnson Syndrome or Toxic
Epidermal Necrolysis, or a rash otherwise requiring hospitalization.
5. Subject has experienced a rash related to prior LAMICTAL use, or for whom LAMICTAL
treatment was discontinued for clinically significant safety reasons.
6. Subject has received any antidepressant medication, or atomoxetine, during the four
weeks prior to the Screen Visit.
7. Subject has initiated psychotherapy within 2 months prior to the Screen Visit, or
plans to initiate psychotherapy during the trial.
8. Subject in the 10-12 year old age group has a Body Mass Index (BMI) less than or
equal 15 or greater than or equal to 30; a subject in the 13-17 year old age group
has a BMI less than or equal to 17 or greater than or equal to 34.
9. Subject tests positive for illicit drug use at the Screen Visit, has a history of
alcohol or substance abuse or dependence (other than nicotine dependence) within the
past three months, or has a positive blood alcohol level at the Screen Visit.
10. Subject, in the investigator's judgment, poses a current homicidal or serious
suicidal risk, has made a suicide attempt within the twelve months preceding the
Screen Visit, has ever been homicidal.
GSK Investigational Site, Dothan, Alabama 36303, United States; Recruiting
GSK Investigational Site, Scottsdale, Arizona 85251, United States; Recruiting
GSK Investigational Site, San Diego, California 92108, United States; Recruiting
GSK Investigational Site, Stanford, California 94305, United States; Recruiting
GSK Investigational Site, Washington, District of Columbia 20010, United States; Recruiting
GSK Investigational Site, Winter Park, Florida 32789, United States; Recruiting
GSK Investigational Site, Tampa, Florida 33613, United States; Recruiting
GSK Investigational Site, Bradenton, Florida 34208, United States; Recruiting
GSK Investigational Site, Gainesville, Florida 32607, United States; Completed
GSK Investigational Site, Jacksonville, Florida 32216, United States; Completed
GSK Investigational Site, Smyrna, Georgia 30080, United States; Recruiting
GSK Investigational Site, Libertyville, Illinois 60048, United States; Recruiting
GSK Investigational Site, Indianapolis, Indiana 46202, United States; Recruiting
GSK Investigational Site, Overland Park, Kansas 66211, United States; Recruiting
GSK Investigational Site, Newton, Kansas 67114, United States; Recruiting
GSK Investigational Site, Shreveport, Louisiana 71103, United States; Recruiting
GSK Investigational Site, Worcester, Massachusetts 01605, United States; Not yet recruiting
GSK Investigational Site, Springfield, Massachusetts 01199, United States; Recruiting
GSK Investigational Site, Boston, Massachusetts 02114, United States; Not yet recruiting
GSK Investigational Site, Boston, Massachusetts 02115, United States; Recruiting
GSK Investigational Site, Rochester, Minnesota 55905, United States; Not yet recruiting
GSK Investigational Site, Minneapolis, Minnesota 55454, United States; Active, not recruiting
GSK Investigational Site, St. Charles, Missouri 63301, United States; Recruiting
GSK Investigational Site, Lincoln, Nebraska 68510, United States; Recruiting
GSK Investigational Site, Piscataway, New Jersey 08854, United States; Not yet recruiting
GSK Investigational Site, Mount Kisco, New York 10549, United States; Recruiting
GSK Investigational Site, Stonybrook, New York 11794-8790, United States; Recruiting
GSK Investigational Site, Chapel Hill, North Carolina 27599, United States; Not yet recruiting
GSK Investigational Site, Fargo, North Dakota 58104, United States; Withdrawn
GSK Investigational Site, Cleveland, Ohio 44106, United States; Recruiting
GSK Investigational Site, Cincinnati, Ohio 45229-3039, United States; Recruiting
GSK Investigational Site, Columbus, Ohio 43210, United States; Recruiting
GSK Investigational Site, Cincinnati, Ohio 45219, United States; Recruiting
GSK Investigational Site, Philadelphia, Pennsylvania 19104, United States; Recruiting
GSK Investigational Site, Houston, Texas 77008, United States; Recruiting
GSK Investigational Site, Dallas, Texas 75235, United States; Recruiting
GSK Investigational Site, Houston, Texas 77007, United States; Recruiting
GSK Investigational Site, Salt Lake City, Utah 84132, United States; Recruiting
GSK Investigational Site, Seattle, Washington 98105, United States; Not yet recruiting
GSK Investigational Site, Kirkland, Washington 98033, United States; Recruiting
