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| Sponsor: | Lindner Center of HOPE |
|---|---|
| Collaborators: |
GlaxoSmithKline University of Cincinnati |
| Information provided by: | Lindner Center of HOPE |
| ClinicalTrials.gov Identifier: | NCT00277641 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Binge Eating Disorder Obesity |
Drug: Lamotrigine Drug: placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | Lamotrigine in the Treatment of Binge Eating Disorder Associated With Obesity: A Single-Center, Double-Blind, Placebo-Controlled, Flexible-Dose Study in Outpatients |
| Estimated Enrollment: | 70 |
| Study Start Date: | March 2006 |
| Study Completion Date: | January 2009 |
| Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
lamotrigine
|
Drug: Lamotrigine
25 mg or 100 mg
|
| Placebo Comparator: 2 |
Drug: placebo
identical tablets to study drug
|
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).
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients will meet DSM-IV-TR criteria for BED for at least the last 6 months, determined by the Structured Clinical Interview for DSM-IV-TR (SCID) (61) and supported by the Eating Disorder Examination (EDE) (62). These criteria are as follows:
Recurrent episodes of binge eating. An episode of binge eating is characterized by both of the following:
The binge eating episodes are associated with at least three of the following:
Exclusion Criteria:
Contacts and Locations| United States, Ohio | |
| Lindner Center of HOPE | |
| Mason, Ohio, United States, 45040 | |
| Principal Investigator: | Susan L. McElroy, MD | Lindner Center of HOPE |
More Information
| Responsible Party: | Susan L. McElroy, MD, University of Cincinnati & Lindner Center of HOPE |
| ClinicalTrials.gov Identifier: | NCT00277641 History of Changes |
| Other Study ID Numbers: | 106531 |
| Study First Received: | January 12, 2006 |
| Last Updated: | June 21, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
Binge Eating Disorder Associated with Obesity |
|
Bulimia Bulimia Nervosa Binge-Eating Disorder Eating Disorders Obesity Hyperphagia Signs and Symptoms, Digestive Signs and Symptoms Mental Disorders Overnutrition Nutrition Disorders |
Overweight Body Weight Lamotrigine Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Cardiovascular Agents Therapeutic Uses Anticonvulsants Central Nervous System Agents |