Lamictal as Add-on Treatment for Bipolar I Disorder in Pediatric Patients

Condition(s) targeted: Bipolar I Disorder

Intervention: lamictal (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Chair, Affiliation: GlaxoSmithKline

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).

Official title: The Evaluation of Lamictal as an Add-on Treatment for Bipolar I Disorder in Children and Adolescents, 10 to 17 Years of Age

Study design: Treatment, Uncontrolled, Parallel Assignment, Safety/Efficacy Study

Primary outcome: The primary efficacy endpoint is the time from randomization to the occurence of a bipolar event.

Secondary outcome: Time from randomization to withdrawal from the study for any cause. Time from randomization to intervention for a mood episode. Time from randomization to intervention for depression, mania/hypomania, or a mixed episode.

Minimum age: 10 Years. Maximum age: 17 Years. Gender(s): Both.

Criteria:

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 Clinical Trials Call Center, Scottsdale, Arizona 85251, United States; Recruiting
Lydia Cohan, Phone: 877-379-3718

GSK Clinical Trials Call Center, San Diego, California 92108, United States; Recruiting
Michael McManus, Phone: 877-379-3718

GSK Clinical Trials Call Center, Aurora, Colorado 80045, United States; Terminated

GSK Clinical Trials Call Center, Washington, District of Columbia 20010, United States; Not yet recruiting
Adelaide Robb, Phone: 877-379-3718

GSK Clinical Trials Call Center, Tampa, Florida 33613, United States; Not yet recruiting
Heidi Bruty, Phone: 877-379-3718

GSK Clinical Trials Call Center, Jacksonville, Florida 32216, United States; Recruiting
Anjali Pathak, Phone: 877-379-3718

GSK Clinical Trials Call Center, Gainesville, Florida 32607, United States; Not yet recruiting
Elias Sarkis, Phone: 877-379-3718

GSK Clinical Trials Call Center, Winter Park, Florida 32789, United States; Not yet recruiting
Irving Kolin, Phone: 877-379-3718

GSK Clinical Trials Call Center, Bradenton, Florida 34208, United States; Recruiting
Jose Zaglul, Phone: 877-379-3718

GSK Clinical Trials Call Center, Smyrna, Georgia 30080, United States; Not yet recruiting
Attalla Ashraf, Phone: 877-379-3718

GSK Clinical Trials Call Center, Dothan, Georgia 36303, United States; Recruiting
Nelson Handal, Phone: 877-379-3718

GSK Clinical Trials Call Center, Stanford, Georgia 94304, United States; Not yet recruiting
Kiki Chang, Phone: 877-379-3718

GSK Clinical Trials Call Center, Libertyville, Illinois 60048, United States; Not yet recruiting
Michael Greenbaum, Phone: 877-379-3718

GSK Clinical Trials Call Center, Indianapolis, Indiana 46202, United States; Not yet recruiting
David Dunn, Phone: 877-379-3718

GSK Clinical Trials Call Center, Newton, Kansas 67114, United States; Not yet recruiting
Deborah Bergen, Phone: 877-379-3718

GSK Clinical Trials Call Center, Overland Park, Kansas 66211, United States; Not yet recruiting
Rory Murphy, Phone: 877-379-3718

GSK Clinical Trials Call Center, Owensboro, Kentucky 42301, United States; Not yet recruiting
Andrew Sedillo, Phone: 877-379-3718

GSK Clinical Trials Call Center, Shreveport, Louisiana 71103, United States; Not yet recruiting
Anita Kablinger, Phone: 877-379-3718

GSK Clinical Trials Call Center, Baltimore, Maryland 21208, United States; Recruiting
Robert Lehman, Phone: 877-379-3718

GSK Clinical Trials Call Center, Boston, Massachusetts 02115, United States; Not yet recruiting
Joseph Gonzalez-Heydrich, Phone: 877-379-3718

GSK Clinical Trials Call Center, Cambridge, Massachusetts 02155, United States; Not yet recruiting
Jean Frazier, Phone: 877-379-3718

GSK Clinical Trials Call Center, Cambridge, Massachusetts 02138, United States; Not yet recruiting
Gagan Joshi, Phone: 877-379-3718

GSK Clinical Trials Call Center, Springfield, Massachusetts 01199, United States; Not yet recruiting
Bruce Waslick, Phone: 877-379-3718

GSK Clinical Trials Call Center, Rochester, Michigan 48309, United States; Not yet recruiting
Sencan Unal, Phone: 877-379-3718

GSK Clinical Trials Call Center, St. Charles, Missouri 63301, United States; Recruiting
Richard Anderson, Phone: 877-379-3718

GSK Clinical Trials Call Center, Lincoln, Nebraska 68510, United States; Recruiting
Walter Duffy, Phone: 877-379-3718

GSK Clinical Trials Call Center, Piscataway, New Jersey 08854, United States; Not yet recruiting
Theodore Petti, Phone: 877-379-3718

GSK Clinical Trials Call Center, Mount Kisco, New York 10549, United States; Recruiting
Jeanette Cueva, Phone: 877-379-3718

GSK Clinical Trials Call Center, Stonybrook, New York 11794, United States; Not yet recruiting
Gabrielle Carlson, Phone: 877-379-3718

GSK Clinical Trials Call Center, Chapel Hill, North Carolina 27599, United States; Not yet recruiting
Jair Soares, Phone: 877-379-3718

GSK Clinical Trials Call Center, Fargo, North Dakota 58104, United States; Not yet recruiting
Natalya Bronson, Phone: 877-379-3718

GSK Clinical Trials Call Center, Cincinnati, Ohio 45267, United States; Not yet recruiting
Melissa Del Bello, Phone: 877-379-3718

GSK Clinical Trials Call Center, Cleveland, Ohio 44106, United States; Not yet recruiting
Robert Finding, Phone: 877-379-3718

GSK Clinical Trials Call Center, Toledo, Ohio 43609, United States; Not yet recruiting
Kettlie Daniels, Phone: 877-379-3718

GSK Clinical Trials Call Center, Cincinnati, Ohio 45229, United States; Not yet recruiting
Robert Kowatch, Phone: 877-379-3718

GSK Clinical Trials Call Center, Columbus, Ohio 43210, United States; Not yet recruiting
Ghada Lteif, Phone: 877-379-3718

GSK Clinical Trials Call Center, Philadelphia, Pennsylvania 19104, United States; Not yet recruiting
Elizabeth Weller, Phone: 877-379-3718

GSK Clinical Trials Call Center, Memphis, Tennessee 38105, United States; Terminated

GSK Clinical Trials Call Center, Dallas, Texas 75235, United States; Not yet recruiting
Kirti Saxena, Phone: 877-379-3718

GSK Clinical Trials Call Center, Houston, Texas 77007, United States; Not yet recruiting
Matthew Brams, Phone: 877-379-3718

GSK Clinical Trials Call Center, Houston, Texas 77008, United States; Not yet recruiting
Alain Katic, Phone: 877-379-3718

GSK Clinical Trials Call Center, Salt Lake City, Utah 84132, United States; Not yet recruiting
Frederick Reimherr, Phone: 877-379-3718

GSK Clinical Trials Call Center, Seattle, Washington 98105, United States; Not yet recruiting
Kathleen Meyers, Phone: 877-379-3718

GSK Clinical Trials Call Center, Kirkland, Washington 98033, United States; Not yet recruiting
James Knutson, Phone: 877-379-3718

Starting date: July 2008
Last updated: September 5, 2008