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

Bulimia Nervosa Clinical Trial

Official title:

Antiglutamatergic Treatment of Bulimia Nervosa and Body Dysmorphic Disorder: An Open-Label Trial of Memantine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01038128
• Other study ID #: 2009-P-001901
• Status: Completed
• Phase: N/A
• First received: December 21, 2009
• Last updated: April 13, 2015
• Start date: December 2009
• Est. completion date: May 2011

Study information

• Verified date: April 2015
• Source: Mclean Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Body Dysmorphic Disorder
• Body Dysmorphic Disorders
• Bulimia
• Bulimia Nervosa
• Disease

Intervention

Drug:
• Memantine
Drug: Memantine, 10-40 mg daily

Locations

Country	Name	City	State
United States	McLean Hospital	Belmont	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Mclean Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Binge Eating and Self-induced Vomiting Episodes	Number of self-reported binge eating and self-induced vomiting episodes during the week prior to the Baseline and Endpoint Visits.	Baseline to 12 weeks	No
Primary	Ratings of Eating Pathology	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.	Baseline to 12 weeks	No
Primary	Clinical Global Impression Scale	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).	Baseline to 12 weeks	No
Primary	Body Dysmorphic Disorder Version of the Yale Brown Obsessive Compulsive Scale	The scale ranges from 0 to 91 units, with 0 representing the least ill and 91 representing the most ill.	Baseline to 12 weeks	No
Primary	Brown Assessments of Belief Scale	The range for this scale is 0 to 28 units, with 0 representing the least ill and 28 representing the most ill.	Baseline to 12 weeks	No