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| Sponsor: | Mclean Hospital |
|---|---|
| Collaborator: |
Forest Laboratories |
| Information provided by: | Mclean Hospital |
| ClinicalTrials.gov Identifier: | NCT00330655 |
Purpose
We hypothesize that memantine may be a safe and effective treatment for moderate to severe binge eating disorder associated with obesity.
During this 12-week, open-label, outpatient study, male and female subjects between the ages of 18 and 65 years who have moderate to severe binge eating disorder and are obese will be treated with open-label memantine. Following this 12-week treatment phase, subjects may be eligible to continue into an extension phase which will last an additional 12 weeks. During the extension phase subjects will continue open-label memantine treatment.
| Condition | Intervention | Phase |
|---|---|---|
|
Binge Eating Disorder |
Drug: memantine |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-Label, Prospective Trial of Memantine in the Treatment of Moderate to Severe Binge Eating Disorder Associated With Obesity |
| Enrollment: | 15 |
| Study Start Date: | May 2006 |
| Study Completion Date: | July 2007 |
Binge eating disorder is a newly recognized disorder characterized by recurrent episodes of binge eating without extreme behaviors to lose weight characteristic of bulimia nervosa or anorexia nervosa and it is associated with overweight and obesity in both clinical and community populations. Preliminary clinical data from a recent, small, 5-week, open-label therapeutic trial in obese patients with binge eating disorder in Germany found memantine to be effective in weight reduction and reduction of binge episodes.
We plan to study 15 male and female subjects between the ages of 18 and 65 years who have binge eating disorder (with 3 or more binge days per week in the 2 weeks prior to baseline) and have a body mass index (BMI) between 30 and 50 kg/m2. During the 12-week treatment phase subjects will receive open-label memantine titrated up to 20mg/day, or the subjects maximum tolerated dose. Upon completion of the treatment phase, subjects will either taper their study medication and return for a final post-taper visit or continue on their current dose of study medication in the 12-week extension phase.
Eligibility| Ages Eligible for Study: | 16 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Massachusetts | |
| McLean Hospital | |
| Belmont, Massachusetts, United States, 02478 | |
| Principal Investigator: | James I Hudson, M.D., Sc.D. | Mclean Hospital |
More Information
| ClinicalTrials.gov Identifier: | NCT00330655 History of Changes |
| Other Study ID Numbers: | 2006-P-000296/1 |
| Study First Received: | May 25, 2006 |
| Last Updated: | August 10, 2007 |
| Health Authority: | United States: Food and Drug Administration |
|
Binge eating Obesity Eating disorder |
|
Bulimia Bulimia Nervosa Binge-Eating Disorder Eating Disorders Hyperphagia Signs and Symptoms, Digestive Signs and Symptoms Mental Disorders Memantine Dopamine Agents |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Antiparkinson Agents Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses |