An Open-Label Trial of Memantine in the Treatment of Binge Eating Disorder
Information source: Mclean Hospital
Information obtained from ClinicalTrials.gov on March 21, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Binge Eating Disorder
Intervention: memantine (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Mclean Hospital Official(s) and/or principal investigator(s):
James I Hudson, M.D., Sc.D., Principal Investigator, Affiliation: Mclean Hospital
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.
Clinical Details
Official title: An Open-Label, Prospective Trial of Memantine in the Treatment of Moderate to Severe Binge Eating Disorder Associated With Obesity
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
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.
Eligibility
Minimum age: 16 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
Locations and Contacts
McLean Hospital, Belmont, Massachusetts 02478, United States
Additional Information
Starting date: May 2006
Ending date: July 2007
Last updated: August 10, 2007
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