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

• Status: Completed
• Trial end date: 2007-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mclean Hospital
• Collaborator: Forest Laboratories
• Treatments: Memantine

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