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

Condition(s) targeted: Bipolar Disorder

Intervention: lamictal (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: GlaxoSmithKline

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

Overall contact:
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: GSKClinicalSupportHD@gsk.com

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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

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

- Subject is male or female between the ages of 10 and 17 years, inclusive.

- Subject has a diagnosis of bipolar I disorder and is currently experiencing a

manic/hypomanic, depressed, or mixed mood episode

- Subject is currently receiving a stable treatment regimen.

- Subject is living with his/her custodial parent(s) or legal guardian(s) and has

contact with them on a daily basis.

Exclusion Criteria

- 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.

- Subject currently has signs or symptoms of psychosis or a history of psychosis within

the previous four weeks.

- Subject has been diagnosed with epilepsy, autism, Asperger's syndrome, or Tourette's

syndrome.

- Subject has experienced a serious rash, such as Stevens-Johnson Syndrome or Toxic

Epidermal Necrolysis, or a rash otherwise requiring hospitalization.

- Subject has experienced a rash related to prior LAMICTAL use, or for whom LAMICTAL

treatment was discontinued for clinically significant safety reasons.

- Subject has received any antidepressant medication, or atomoxetine, during the four

weeks prior to the Screen Visit.

- Subject has initiated psychotherapy within 2 months prior to the Screen Visit, or

plans to initiate psychotherapy during the trial.

- 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.

- 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.

- 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.

US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: GSKClinicalSupportHD@gsk.com

GSK Investigational Site, Dothan, Alabama 36303, United States; Completed

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GSK Investigational Site, San Diego, California 92108, United States; Recruiting
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Center, Phone: +44 (0) 20 8990 4466, Email: GSKClinicalSupportHD@gsk.com

GSK Investigational Site, Stanford, California 94305, United States; Recruiting
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Center, Phone: +44 (0) 20 8990 4466, Email: GSKClinicalSupportHD@gsk.com

GSK Investigational Site, Washington, District of Columbia 20010, United States; Recruiting
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Center, Phone: +44 (0) 20 8990 4466, Email: GSKClinicalSupportHD@gsk.com

GSK Investigational Site, Bradenton, Florida 34208, United States; Completed

GSK Investigational Site, Orlando, Florida 32839, United States; Not yet recruiting
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Center, Phone: +44 (0) 20 8990 4466, Email: GSKClinicalSupportHD@gsk.com

GSK Investigational Site, Tampa, Florida 33613, United States; Completed

GSK Investigational Site, Winter Park, Florida 32789, United States; Completed

GSK Investigational Site, Smyrna, Georgia 30080, United States; Recruiting
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Center, Phone: +44 (0) 20 8990 4466, Email: GSKClinicalSupportHD@gsk.com

GSK Investigational Site, Libertyville, Illinois 60048, United States; Recruiting
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Center, Phone: +44 (0) 20 8990 4466, Email: GSKClinicalSupportHD@gsk.com

GSK Investigational Site, Naperville, Illinois 60563, United States; Recruiting
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Center, Phone: +44 (0) 20 8990 4466, Email: GSKClinicalSupportHD@gsk.com

GSK Investigational Site, Indianapolis, Indiana 46202, United States; Recruiting
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Center, Phone: +44 (0) 20 8990 4466, Email: GSKClinicalSupportHD@gsk.com

GSK Investigational Site, Overland Park, Kansas 66211, United States; Recruiting
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Center, Phone: +44 (0) 20 8990 4466, Email: GSKClinicalSupportHD@gsk.com

GSK Investigational Site, Wichita, Kansas 67206, United States; Completed

GSK Investigational Site, Shreveport, Louisiana 71103, United States; Completed

GSK Investigational Site, Boston, Massachusetts 02115, United States; Recruiting
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Center, Phone: +44 (0) 20 8990 4466, Email: GSKClinicalSupportHD@gsk.com

GSK Investigational Site, Springfield, Massachusetts 01199, United States; Completed

GSK Investigational Site, Worcester, Massachusetts 01605, United States; Recruiting
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Center, Phone: +44 (0) 20 8990 4466, Email: GSKClinicalSupportHD@gsk.com

GSK Investigational Site, Rochester, Minnesota 55905, United States; Completed

GSK Investigational Site, St. Charles, Missouri 63301, United States; Completed

GSK Investigational Site, Lincoln, Nebraska 68526, United States; Recruiting
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Center, Phone: +44 (0) 20 8990 4466, Email: GSKClinicalSupportHD@gsk.com

GSK Investigational Site, Albuquerque, New Mexico 87109, United States; Recruiting
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Center, Phone: +44 (0) 20 8990 4466, Email: GSKClinicalSupportHD@gsk.com

GSK Investigational Site, Mount Kisco, New York 10549, United States; Recruiting
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Center, Phone: +44 (0) 20 8990 4466, Email: GSKClinicalSupportHD@gsk.com

GSK Investigational Site, Stonybrook, New York 11794-8790, United States; Recruiting
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Center, Phone: +44 (0) 20 8990 4466, Email: GSKClinicalSupportHD@gsk.com

GSK Investigational Site, Chapel Hill, North Carolina 27599, United States; Completed

GSK Investigational Site, Cincinnati, Ohio 45219, United States; Recruiting
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Center, Phone: +44 (0) 20 8990 4466, Email: GSKClinicalSupportHD@gsk.com

GSK Investigational Site, Cincinnati, Ohio 45229-3039, United States; Completed

GSK Investigational Site, Cleveland, Ohio 44106, United States; Recruiting
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Center, Phone: +44 (0) 20 8990 4466, Email: GSKClinicalSupportHD@gsk.com

GSK Investigational Site, Columbus, Ohio 43210, United States; Recruiting
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Center, Phone: +44 (0) 20 8990 4466, Email: GSKClinicalSupportHD@gsk.com

GSK Investigational Site, Philadelphia, Pennsylvania 19104, United States; Completed

GSK Investigational Site, Dallas, Texas 75235, United States; Completed

GSK Investigational Site, Houston, Texas 77054, United States; Not yet recruiting
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Center, Phone: +44 (0) 20 8990 4466, Email: GSKClinicalSupportHD@gsk.com

GSK Investigational Site, Houston, Texas 77008, United States; Completed

GSK Investigational Site, Houston, Texas 77007, United States; Completed

GSK Investigational Site, Salt Lake City, Utah 84132, United States; Completed

GSK Investigational Site, Roanoke, Virginia 24014, United States; Recruiting
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Center, Phone: +44 (0) 20 8990 4466, Email: GSKClinicalSupportHD@gsk.com

GSK Investigational Site, Kirkland, Washington 98033, United States; Recruiting
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Center, Phone: +44 (0) 20 8990 4466, Email: GSKClinicalSupportHD@gsk.com

GSK Investigational Site, Seattle, Washington 98105, United States; Completed

Starting date: July 2008
Last updated: November 17, 2011