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OpenTrials
Completed

NCT Number: NCT00330655

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

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.

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Key information

Age range

16 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

McLean Hospital

Belmont, Massachusetts, 02478, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Memantine

Drug

Sponsors and collaborators

Lead sponsor

Mclean Hospital

Other

Collaborators

  • Forest Laboratories

Registry information

Official study title

An Open-Label, Prospective Trial of Memantine in the Treatment of Moderate to Severe Binge Eating Disorder Associated With Obesity

Important dates

Study start
2006
Study completion
2007
First posted
May 29, 2006
Registry last updated
Aug 14, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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