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

NCT ID: NCT00330655

Last Updated: 2007-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-05-31
• Study Completion Date: 2007-07-31

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.

Conditions

Binge Eating Disorder

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

memantine

Intervention Type: DRUG

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Forest Laboratories

INDUSTRY

Sponsor Role: collaborator

Mclean Hospital

OTHER

Sponsor Role: lead

Principal Investigators

James I Hudson, M.D., Sc.D.

Role: PRINCIPAL_INVESTIGATOR

Mclean Hospital

Locations

McLean Hospital

Belmont, Massachusetts, United States

Countries

United States

Other Identifiers

2006-P-000296/1

Identifier Type: -

Identifier Source: org_study_id