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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
James I. Hudson, MD, Mclean Hospital
ClinicalTrials.gov Identifier:
NCT01038128
First received: December 21, 2009
Last updated: May 9, 2012
Last verified: May 2012
  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

Resource links provided by NLM:


Further study details as provided by Mclean Hospital:

Primary Outcome Measures:
  • 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.


Enrollment: 5
Study Start Date: December 2009
Study Completion Date: May 2011
Primary Completion Date: May 2011 (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

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).

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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:

  • Participants must meet DSM-IV criteria for a current diagnosis of body dysmorphic disorder as determined by the SCID.
  • Participants must exhibit a score of ≥ 20 on the Body Dysmorphic Disorder Version of the Yale Brown Obsessive Compulsive Scale (BDD-YBOCS) at a score of ≥ 5 on the first three items of the BDD-YBOCS, which are the items that assess the DSM-IV criteria for Body Dysmorphic Disorder.

Exclusion Criteria for both Bulimia Nervosa and Body Dysmorphic Disorder:

  • Participants with a lifetime diagnosis of schizophrenia, other psychotic disorder, or bipolar disorder as defined by DSM-IV and supported by the SCID.
  • Participants with clinically significant current depression or who, in the investigators' judgment, might require intervention with either pharmacological or non-pharmacological therapy for major depressive disorder over the course of the study.
  • Participants judged clinically to be at suicidal or homicidal risk by the study physician.
  • Participants meeting DSM-IV criteria for any form of substance dependence or abuse (with the exception of nicotine or caffeine dependence) within 3 months prior to the screening visit.
  • Participants meeting DSM-IV criteria for anorexia nervosa within 3 months prior to the screening visit.
  • Participants with a current DSM-IV diagnosis of an organic mental disorder.
  • Participants who have begun to receive formal psychotherapy (cognitive-behavioral therapy, interpersonal therapy or self-guided cognitive-behavioral therapy) for bulimia nervosa within 6 months prior to the screening visit.
  • Participants who display a positive urine screen for drugs of abuse (phencyclidine, cocaine, amphetamines, tetrahydrocannabinol, and opiates) at the screening visit.
  • Participants who have previously received memantine for any reason.
  • Participants who have received an investigational medication within 30 days of the screening visit.
  • Participants who are pregnant or lactating.
  • Participants with a body mass index (BMI) less than 18.5 or greater than 35.
  • Participants who have abused ipecac as a method of purging within the past 2 years.
  • Participants who exhibit a serum potassium level of less than 3.0 mEq/L.
  • Participants with thyroid-stimulating hormone concentrations outside the range of 0.5-5.0 lU/mL.
  • Participants with clinically significant or unstable medical conditions
  • Participants who in the opinion of the investigator should not be enrolled in the study because of the precautions, warnings or contraindications sections of the prescribing information for memantine
  • Employees of the investigator, individuals with direct involvement in studies under the direction of the study investigators, as well as family members of the employees of the investigators.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01038128

Locations
United States, Massachusetts
McLean Hospital
Belmont, Massachusetts, United States, 02478
Sponsors and Collaborators
Mclean Hospital
Investigators
Principal Investigator: James I Hudson, M.D., Sc.D. Mclean Hospital
  More Information

No publications provided

Responsible Party: James I. Hudson, MD, Professor of Psychiatry, Harvard Medical School, Mclean Hospital
ClinicalTrials.gov Identifier: NCT01038128     History of Changes
Other Study ID Numbers: 2009-P-001901
Study First Received: December 21, 2009
Results First Received: March 19, 2012
Last Updated: May 9, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Mclean Hospital:
Bulimia nervosa
Bulimia
Body dysmorphic disorder
Eating disorders
Body image
Binge eating
purging

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on April 21, 2014