Lamictal as Add-on Treatment for Bipolar I Disorder in Pediatric Patients
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Intervention: lamictal
Intervention description: Flexible Dosing
Intervention MeSH terms: Lamotrigine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 301.0
Sex: All
Minimum age: 10 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Bipolar I pediatric lamictal adolescent

Summary:

      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).
    

Eligibility 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.