Lamotrigine Monotherapy in Pediatric Bipolar Disorder
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Intervention: Lamotrigine
Intervention description: It is a mood stabilizer that is clinically the first choice if patients present with depression and is effective in adults for mania in maintenance phase. So it is administered to see how effective it is in children and adolescents.
The dose of lamotrigine will be 12.5 mg per day beginning the first day. It is increased in 12.5 mg increments every week until it reaches 50 mg and 25 mg per week of increment thereafter until maximum dose of 150 mg in those below 50 kg and 200-400 mg depending on clinical response in those above 50 kg.
Intervention MeSH terms: Lamotrigine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 48.0
Sex: All
Minimum age: 10 Years
Maximum age: 20 Years
Healthy volunteers: No

Summary:

      There are two purposes for this project. Study 1 is intended to study the safety and efficacy
      of Lamotrigine in stabilizing the mood in all phases of pediatric bipolar disorder (Phases:
      mixed, manic, hypomanic, or depressed episodes) in 8-17 year old children. These children and
      adolescents must be treatment resistant (who failed on two adequate trials of mood
      stabilizing medications) to qualify for this study. Study 2 is aimed at examining brain
      activity and/or dysfunction before lamotrigine treatment, and to look for any alteration
      after lamotrigine treatment. Brain systems associated with attention and emotional processing
      will targeted.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ages 10-20

          -  Must be able to swallow tablets

          -  Must be diagnosed with bipolar disorder

        Exclusion Criteria:

          -  Children with general medical condition such as head injury, epilepsy, endocrine
             disorders

          -  Those who are on mood altering medications such as steroids, and those diagnosed with
             mental retardation are excluded to avoid confounding and contributing factors to mood
             swings.

          -  If we discover during the interview that the parent and/or child does not understand
             the consent/assent procedures, we will exclude them.

          -  Girls who are pregnant or plan to become pregnant during the study period will also be
             excluded from the research. There have been no concerns raised in the literature about
             the need for birth control practices in males treated with lamotrigine. As such, there
             are no provisions to exclude males from the research who do not practice birth
             control.

        We expect only a small number of children to be excluded from the study due to exclusionary
        criteria. Selection of the subjects is not based on sex, race, or ethnic group.

        For the fMRI study:

          -  Given the limited size of the magnet bore, individuals with a body weight over
             two-hundred and fifty pounds will be unable to be tested within the MRI scanner.

          -  Women in the latter stages of pregnancy may be excluded due to large body size and
             potential discomfort while in the MRI apparatus. Please note that girls who are taking
             part in the drug portion of the study (this includes all female subjects except the 5
             healthy adult, control women) will be given 3 pregnancy during the drug study. This is
             to rule out pregnancy since pregnant girls should not be taking the study medications
             for safety reasons.

          -  Standard contraindications for fMRI studies include: cardiac pacemaker, aneurysm clip,
             cochlear implants, shrapnel, history of metal fragments in eyes, claustrophobia

          -  Participants with an IQ of less than 70 (assessed by WRAT) are likely to be excluded
             due to difficulties comprehending tasks and procedures