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| Sponsor: | Mclean Hospital |
|---|---|
| Information provided by: | Mclean Hospital |
| ClinicalTrials.gov Identifier: | NCT01038128 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Bulimia Nervosa Body Dysmorphic Disorder |
Drug: Memantine |
| Study Type: | Interventional |
| 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 |
| Estimated Enrollment: | 20 |
| Study Start Date: | December 2009 |
| Estimated Study Completion Date: | August 2010 |
| Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Memantine
Memantine, 10-40 mg daily
|
Drug: Memantine
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).
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria: Bulimia Nervosa
Inclusion Criteria: Body Dysmorphic Disorder
Inclusion criteria for participants with body dysmorphic disorder are identical to those for bulimia nervosa above, with the following differences in the first two criteria:
Exclusion Criteria for both Bulimia Nervosa and Body Dysmorphic Disorder:
Contacts and Locations| Contact: Caitlin E Coit, BA | 617-855-2984 | ccoit@mclean.harvard.edu |
| Contact: Ashley M Beauleu, BA | 617-855-2434 | abeaulieu@mclean.harvard.edu |
| United States, Massachusetts | |
| McLean Hospital | Recruiting |
| Belmont, Massachusetts, United States, 02478 | |
| Contact: Caitlin E Coit, BA 617-855-2984 ccoit@mclean.harvard.edu | |
| Contact: Ashley M Beaulieu, BA 617-855-2434 abeaulieu@mclean.harvard.edu | |
| Sub-Investigator: Harrison G Pope, M.D. | |
| Sub-Investigator: Brian P Brennan, M.D. | |
| Sub-Investigator: William P Carter, M.D. | |
| Sub-Investigator: Brian Clinton, M.D. | |
| Principal Investigator: | James I Hudson, M.D., Sc.D. | Mclean Hospital |
More Information
| Responsible Party: | James Hudson, M.D., Sc.D., McLean Hospital, Biological Psychiatry Laboratory |
| ClinicalTrials.gov Identifier: | NCT01038128 History of Changes |
| Other Study ID Numbers: | 2009-P-001901 |
| Study First Received: | December 21, 2009 |
| Last Updated: | June 3, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
Bulimia nervosa Bulimia Body dysmorphic disorder BDD |
Eating disorders Body image Binge eating purging |
|
Body Dysmorphic Disorders Bulimia Bulimia Nervosa Somatoform Disorders Mental Disorders Hyperphagia Signs and Symptoms, Digestive Signs and Symptoms Eating Disorders Memantine Dopamine Agents |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Antiparkinson Agents Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses |