An Open-Label Trial of Memantine in the Treatment of Binge Eating Disorder

• ClinicalTrials.gov Identifier: NCT00330655
• Recruitment Status: Completed
• First Posted: May 29, 2006
• Last Update Posted: August 14, 2007
• Sponsor: Mclean Hospital
• Collaborator: Forest Laboratories
• Information provided by: Mclean Hospital

Tracking Information

• First Submitted Date: May 25, 2006
• First Posted Date: May 29, 2006
• Last Update Posted Date: August 14, 2007
• Study Start Date: May 2006
• Primary Completion Date: Not Provided
• Current Primary Outcome Measures: Not Provided
• Original Primary Outcome Measures: Not Provided
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: An Open-Label Trial of Memantine in the Treatment of Binge Eating Disorder
• Official Title: An Open-Label, Prospective Trial of Memantine in the Treatment of Moderate to Severe Binge Eating Disorder Associated With Obesity

Brief Summary

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.

Detailed Description

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.

• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Binge Eating Disorder
• Intervention: Drug: memantine
• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 25, 2006): 15
• Original Enrollment: Same as current
• Actual Study Completion Date: July 2007
• Primary Completion Date: Not Provided

Eligibility Criteria

Inclusion Criteria:

• Subjects may be male or female, 18-65 years old
• Diagnosis of binge eating disorder
• Subjects must have 3 or more binge days per week for the two weeks prior to the start of the study
• Subjects must have a BMI between 30 and 50 kg/m2

Exclusion Criteria:

• Current or lifetime history of schizophrenia, other psychotic disorder, or bipolar disorder
• Subjects with a history of a personality disorder
• Subjects with clinically significant depression
• Subjects with substance use of dependence
• Subjects who are pregnant or lactating
• Subjects with a serious medical condition

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 16 Years to 65 Years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00330655
• Other Study ID Numbers: 2006-P-000296/1
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Not Provided
• Study Sponsor: Mclean Hospital
• Collaborators: Forest Laboratories

Investigators

• Principal Investigator: James I Hudson, M.D., Sc.D.; Mclean Hospital

• PRS Account: Mclean Hospital
• Verification Date: August 2007