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

NCT ID: NCT01038128

Last Updated: 2015-05-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2011-05-31

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).

Conditions

Bulimia Nervosa; Body Dysmorphic Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Memantine

Memantine, 10-40 mg daily

Group Type: EXPERIMENTAL

Memantine

Intervention Type: DRUG

Drug: Memantine, 10-40 mg daily

Interventions

Memantine

Drug: Memantine, 10-40 mg daily

Intervention Type: DRUG

Other Intervention Names

Namenda

Eligibility Criteria

Inclusion Criteria

• 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.

• 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

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mclean Hospital

OTHER

Sponsor Role: lead

Responsible Party

James I. Hudson, MD

Professor of Psychiatry, Harvard Medical School

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

James I Hudson, M.D., Sc.D.

Role: PRINCIPAL_INVESTIGATOR

Mclean Hospital

Locations

McLean Hospital

Belmont, Massachusetts, United States

Countries

United States

Other Identifiers

2009-P-001901

Identifier Type: -

Identifier Source: org_study_id