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An Open-Label Trial of Memantine in the Treatment of Binge Eating Disorder
This study has been completed.
First Received: May 25, 2006   Last Updated: August 10, 2007   History of Changes
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: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Official Title: An Open-Label, Prospective Trial of Memantine in the Treatment of Moderate to Severe Binge Eating Disorder Associated With Obesity

Resource links provided by NLM:


Further study details as provided by Mclean Hospital:

Enrollment: 15
Study Start Date: May 2006
Study Completion Date: July 2007
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

Ages Eligible for Study:   16 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00330655

Locations
United States, Massachusetts
McLean Hospital
Belmont, Massachusetts, United States, 02478
Sponsors and Collaborators
Mclean Hospital
Forest Laboratories
Investigators
Principal Investigator: James I Hudson, M.D., Sc.D. Mclean Hospital
  More Information

No publications provided

Study ID Numbers: 2006-P-000296/1
Study First Received: May 25, 2006
Last Updated: August 10, 2007
ClinicalTrials.gov Identifier: NCT00330655     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Mclean Hospital:
Binge eating
Obesity
Eating disorder

Additional relevant MeSH terms:
Neurotransmitter Agents
Disease
Signs and Symptoms, Digestive
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Antiparkinson Agents
Excitatory Amino Acid Agents
Pharmacologic Actions
Hyperphagia
Bulimia Nervosa
Signs and Symptoms
Pathologic Processes
Mental Disorders
Therapeutic Uses
Bulimia
Memantine
Dopamine Agents
Central Nervous System Agents
Eating Disorders
Excitatory Amino Acid Antagonists

ClinicalTrials.gov processed this record on February 08, 2010