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

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

Study Description
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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.


Condition or disease Intervention/treatment Phase
Binge Eating Disorder Drug: memantine Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Prospective Trial of Memantine in the Treatment of Moderate to Severe Binge Eating Disorder Associated With Obesity
Study Start Date : May 2006
Actual Study Completion Date : July 2007

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Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00330655


Locations
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United States, Massachusetts
McLean Hospital
Belmont, Massachusetts, United States, 02478
Sponsors and Collaborators
Mclean Hospital
Forest Laboratories
Investigators
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Principal Investigator: James I Hudson, M.D., Sc.D. Mclean Hospital
More Information
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ClinicalTrials.gov Identifier: NCT00330655    
Other Study ID Numbers: 2006-P-000296/1
First Posted: May 29, 2006    Key Record Dates
Last Update Posted: August 14, 2007
Last Verified: August 2007
Keywords provided by Mclean Hospital:
Binge eating
Obesity
Eating disorder
Additional relevant MeSH terms:
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Disease
Bulimia
Feeding and Eating Disorders
Binge-Eating Disorder
Pathologic Processes
Mental Disorders
Hyperphagia
Signs and Symptoms, Digestive
Signs and Symptoms
 Memantine
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents