Lamotrigine in the Treatment of Binge Eating Disorder Associated With Obesity
Condition: Binge Eating Disorder; Obesity
MeSH terms: Obesity; Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      This research study is to evaluate the effectiveness, tolerability, and safety of lamotrigine
      therapy in the treatment of binge eating disorder associated with obesity.

      Lamotrigine has been approved by the Food and Drug Administration for the treatment of
      bipolar disorder, but has not been approved for use in the treatment of binge eating disorder
      with obesity.
    

Detailed description: 
      This is a 17-week, parallel group, placebo-controlled, randomized, double-blind,
      flexible-dose, single-center study. It begins with a 1 to 2 week screening period during
      which there will be washout of other medications and evaluation of protocol-specified
      criteria. The screening period will consist of at least two visits, which will include the
      initial screening visit and the baseline (week 1) visit. The treatment period follows the
      screening period and will last 16 weeks. Once a subject enters the treatment phase (after
      randomization) the dosage of study medication will be 25 mg/qHS (or one placebo tablet at
      night) for 14 days. On day 14 (visit 2 or the beginning of week 3), the dosage will be
      increased, as tolerated, to 25 mg b.i.d. On day 28 (visit 4 or in the beginning of week 5),
      the dosage will be increased, as tolerated, to 50 mg b.i.d. On day 35 (visit 5 or the
      beginning of week 6), the dosage will be increased, as tolerated, to 100 mg b.i.d. The dosage
      may be decreased at any time because of side effects. If the patient prefers, he or she may
      take all of his or her daily dose of medication in the morning or evening. If no response or
      an inadequate response (< 50% reduction in binge eating episodes compared with baseline) is
      evident by week 6 (visit 6), study medication may be increased to 150 mg b.i.d. If no
      response or an inadequate response is evident by week 8 (visit 7), study medication may be
      increased to 200 mg b.i.d. During weeks 12 through 16 (maintenance period) the dosage will
      not be changed unless a medical reason (e.g., adverse effect) requires such a change. The
      minimum dosage allowed will be 50 mg/day and the maximum dosage allowed will be 400 mg/day.
      The 16-week treatment period will be followed by medication discontinuation and evaluation 1
      week after medication discontinuation (week 17). Efficacy and safety evaluations will be done
      at each visit starting with the baseline visit through week 17 (baseline, weeks 1, 2, 3, 4,
      5, 6, 8, 10, 12, 14, 16).
    

Intervention name(s): Lamotrigine; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 25 mg or 100 mg; identical tablets to study drug
Intervention MeSH terms: Lamotrigine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Binge Eating Disorder Associated with Obesity