An Open Label Trial of Memantine in the Treatment of Bulimia Nervosa and Body Dysmorphic Disorder
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Antiglutamatergic Treatment of Bulimia Nervosa and Body Dysmorphic Disorder: An Open-Label Trial of Memantine|
- Number of Binge Eating and Self-induced Vomiting Episodes [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: No ]Number of self-reported binge eating and self-induced vomiting episodes during the week prior to the Baseline and Endpoint Visits.
- Ratings of Eating Pathology [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: No ]Ratings obtained from the self-induced vomiting and laxative misuse sections of the Eating Disorder Examination. The scale asks participants to calculate discreet episodes of self-induced vomiting and laxative misuses over the period of four weeks. Generally, the value obtained is the number of occurrences. However, in cases where the number of occurrences was too great to be calculated, the number "777" was used. The scale is therefore open-ended, with higher numbers coinciding with a greater number of episodes.
- Clinical Global Impression Scale [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: No ]Disorder severity is measured based on the Clinical Global Impression Scale. The scale ranges from 1 unit (Not at all ill) to 7 units (extremely ill).
- Body Dysmorphic Disorder Version of the Yale Brown Obsessive Compulsive Scale [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: No ]The scale ranges from 0 to 91 units, with 0 representing the least ill and 91 representing the most ill.
- Brown Assessments of Belief Scale [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: No ]The range for this scale is 0 to 28 units, with 0 representing the least ill and 28 representing the most ill.
|Study Start Date:||December 2009|
|Study Completion Date:||May 2011|
|Primary Completion Date:||May 2011 (Final data collection date for primary outcome measure)|
Memantine, 10-40 mg daily
Drug: Memantine, 10-40 mg daily
Other Name: Namenda
The primary objective of this clinical trial is to test the hypothesis that treatment with Memantine, an anti-glutamatergic drug, will significantly improve the core symptoms of those suffering from either bulimia nervosa, purging type or suffering from body dysmorphic disorder.
We will test this hypothesis by performing a 13-week open label study investigating the use of memantine, at a dose of 10-40mg daily, as a treatment for patients with either bulimia nervosa or body dysmorphic disorder. Improvement for patients with bulimia nervosa will be assessed using the Frequency of binge eating and vomiting as recorded in diary card, Eating Disorder Evaluation (EDE), and the Yale-Brown-Cornell Eating Disorders Scale (YBC-EDS). Improvement for patients with body dysmorphic disorder will be assessed using the the Yale-Brown-Cornell Eating Disorders Scale (YBC-EDS) and Brown Assessments of Beliefs Scale. In addition both groups will also receive the Clinical Global Impression (CGI) Severity and Improvement Scales (clinician rated), Patient Global Impression of Improvement (PGI-Improvement), Montgomery Asberg Depression Rating Scale (MADRS), Hamilton Anxiety Rating Scale (HAM-A), Barratt Impulsiveness Scale (BIS), Version 11, Sheehan Disability Scale (SDS), and Columbia Suicide Severity Rating Scale (C-SSRS).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01038128
|United States, Massachusetts|
|Belmont, Massachusetts, United States, 02478|
|Principal Investigator:||James I Hudson, M.D., Sc.D.||Mclean Hospital|