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Lamictal as Add-on Treatment for Bipolar I Disorder in Pediatric Patients
This study is currently recruiting participants.
Study NCT00723450   Information provided by GlaxoSmithKline
First Received: July 24, 2008   Last Updated: November 19, 2009   History of Changes

July 24, 2008
November 19, 2009
July 2008
 
The primary efficacy endpoint is the time from randomization to the occurence of a bipolar event.
Same as current
Complete list of historical versions of study NCT00723450 on ClinicalTrials.gov Archive Site
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.
Same as current
 
Lamictal as Add-on Treatment for Bipolar I Disorder in Pediatric Patients
The Evaluation of Lamictal as an Add-on Treatment for Bipolar I Disorder in Children and Adolescents, 10 to 17 Years of Age

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).

 
Phase III
Interventional
Treatment, Parallel Assignment, Safety/Efficacy Study
Bipolar Disorder
Drug: lamictal
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
340
 
 

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.
Both
10 Years to 17 Years
No
Contact: US GSK Clinical Trials Call Center 877-379-3718
United States
 
NCT00723450
Study Director, GSK
SCA102833
GlaxoSmithKline
 
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
GlaxoSmithKline
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP