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An Open Label Trial of Memantine in the Treatment of Bulimia Nervosa and Body Dysmorphic Disorder

2014-07-23 21:11:18 | BioPortfolio

Summary

The primary objective of this 13-week clinical trial is to test the hypothesis that treatment with Memantine will significantly improve the symptoms of those suffering from either bulimia nervosa, purging type or suffering from body dysmorphic disorder.

Description

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).

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Bulimia Nervosa

Intervention

Memantine

Location

McLean Hospital
Belmont
Massachusetts
United States
02478

Status

Recruiting

Source

Mclean Hospital

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:11:18-0400

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Medical and Biotech [MESH] Definitions

Eating an excess amount of food in a short period of time, as seen in the disorder of BULIMIA NERVOSA. It is caused by an abnormal craving for food, or insatiable hunger also known as "ox hunger".

An eating disorder that is characterized by a cycle of binge eating (BULIMIA or bingeing) followed by inappropriate acts (purging) to avert weight gain. Purging methods often include self-induced VOMITING, use of LAXATIVES or DIURETICS, excessive exercise, and FASTING.

A disorder associated with three or more of the following: eating until feeling uncomfortably full; eating large amounts of food when not physically hungry; eating much more rapidly than normal; eating alone due to embarrassment; feeling of disgust, DEPRESSION, or guilt after overeating. Criteria includes occurrence on average, at least 2 days a week for 6 months. The binge eating is not associated with the regular use of inappropriate compensatory behavior (i.e. purging, excessive exercise, etc.) and does not co-occur exclusively with BULIMIA NERVOSA or ANOREXIA NERVOSA. (From DSM-IV, 1994)

AMANTADINE derivative that has some dopaminergic effects. It has been proposed as an antiparkinson agent.

The lack or loss of APPETITE accompanied by an aversion to food and the inability to eat. It is the defining characteristic of the disorder ANOREXIA NERVOSA.

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