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

Completed · Phase 3 · Has a placebo group

Conditions studied: Bipolar Disorder

In brief

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).

Key facts

Study ID

NCT00723450

Run by

GlaxoSmithKline

People needed

301

Starts

2008-07-01

Expected to finish

2013-08-01

Last updated by the study team

2017-01-09

Who can join

Age: 10 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• GSK Investigational Site — Dothan, Alabama, United States
• GSK Investigational Site — Scottsdale, Arizona, United States
• GSK Investigational Site — San Diego, California, United States
• GSK Investigational Site — Stanford, California, United States
• GSK Investigational Site — Washington D.C., District of Columbia, United States
• GSK Investigational Site — Bradenton, Florida, United States
• GSK Investigational Site — Gainesville, Florida, United States
• GSK Investigational Site — Jacksonville, Florida, United States
• GSK Investigational Site — Orlando, Florida, United States
• GSK Investigational Site — Tampa, Florida, United States
• GSK Investigational Site — Winter Park, Florida, United States
• GSK Investigational Site — Smyrna, Georgia, United States
• GSK Investigational Site — Libertyville, Illinois, United States
• GSK Investigational Site — Naperville, Illinois, United States
• GSK Investigational Site — Indianapolis, Indiana, United States
• GSK Investigational Site — Overland Park, Kansas, United States
• GSK Investigational Site — Wichita, Kansas, United States
• GSK Investigational Site — Shreveport, Louisiana, United States
• GSK Investigational Site — Baltimore, Maryland, United States
• GSK Investigational Site — Boston, Massachusetts, United States
• GSK Investigational Site — Boston, Massachusetts, United States
• GSK Investigational Site — Springfield, Massachusetts, United States
• GSK Investigational Site — Worcester, Massachusetts, United States
• GSK Investigational Site — Rochester, Minnesota, United States
• GSK Investigational Site — Saint Charles, Missouri, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.