| Conditions: |
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Bulimia Nervosa - Body Dysmorphic Disorder |
| Purpose: |
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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.
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| Study Summary: |
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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).
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| Criteria: |
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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 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 BDD.
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 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.
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| NCT ID: |
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NCT01038128 |
| Primary Contact: |
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Principal Investigator
James I Hudson, M.D., Sc.D.
Mclean Hospital
Caitlin E Coit, BA
Phone: 617-855-2984
Email: ccoit@mclean.harvard.edu
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| Backup Contact: |
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Email: abeaulieu@mclean.harvard.edu
Ashley M Beauleu, BA
Phone: 617-855-2434
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| Location Contact: |
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Belmont, Massachusetts 02478
United States
Caitlin E Coit, BA
Phone: 617-855-2984
Email: ccoit@mclean.harvard.edu
Site Status: Recruiting |