Antiglutamatergic Treatment of Bulimia Nervosa and Body Dysmorphic Disorder: An Open-Label Trial of Memantine
Overview
- Phase
- Not Applicable
- Intervention
- Memantine
- Conditions
- Bulimia Nervosa
- Sponsor
- Mclean Hospital
- Enrollment
- 5
- Locations
- 1
- Primary Endpoint
- Number of Binge Eating and Self-induced Vomiting Episodes
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief 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.
Detailed 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).
Investigators
James I. Hudson, MD
Professor of Psychiatry, Harvard Medical School
Mclean Hospital
Eligibility Criteria
Inclusion Criteria
- •Bulimia Nervosa
- •Participants must meet DSM-IV criteria for a current diagnosis of bulimia nervosa as determined by the Structured Clinical Interview for DSM-IV (SCID) and Eating Disorder Examination (EDE).
- •Participants must report an average of 3 or more binges and vomiting episodes per week in the 2-week period prior to the screening visit.
- •Male or Female between 18 and 65 years of age, inclusive.
- •Female participants must be: postmenopausal for at least one year, surgically sterile, or practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization, abstinence and agreeing to continue abstinence or to use one of the acceptable methods of contraception just enumerated should sexual activity commence) before entry and throughout the study; and have a negative serum pregnancy test at the screening visit.
- •Participants must have observed a designated washout period of at least seven days or a period equal to five half-lives of prohibited medications.
- •Participants must be able to take oral medication, adhere to the medication regimens, and be willing to return for regular visits.
- •Participants must be able and willing to read and comprehend written instructions and comprehend and complete all scales and questionnaires required by the protocol.
- •Participants must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
- •Inclusion Criteria: Body Dysmorphic Disorder
Exclusion Criteria
- Not provided
Arms & Interventions
Memantine
Memantine, 10-40 mg daily
Intervention: Memantine
Outcomes
Primary Outcomes
Number of Binge Eating and Self-induced Vomiting Episodes
Time Frame: Baseline to 12 weeks
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
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
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
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
The range for this scale is 0 to 28 units, with 0 representing the least ill and 28 representing the most ill.