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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Memantine | Experimental | Memantine, 10-40 mg daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Memantine | Drug | Drug: Memantine, 10-40 mg daily |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
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Inclusion Criteria: Bulimia Nervosa
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:
Exclusion Criteria for both Bulimia Nervosa and Body Dysmorphic Disorder:
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| Name | Affiliation | Role |
|---|---|---|
| James I Hudson, M.D., Sc.D. | Mclean Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McLean Hospital | Belmont | Massachusetts | 02478 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Memantine | Memantine, 10-40 mg daily |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Memantine | Memantine, 10-40 mg daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | One subject completed. The remaining two subjects' last observation was carried forward. | Posted | Mean | Standard Deviation | number of episodes | Baseline to 12 weeks |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Memantine | Memantine, 10-40 mg daily |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Coordinator | McLean Hospital | 617-855-2984 | eryan@mclean.harvard.edu |
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| ID | Term |
|---|---|
| D052018 | Bulimia Nervosa |
| D057215 | Body Dysmorphic Disorders |
| D002032 | Bulimia |
| D001068 | Feeding and Eating Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D013001 | Somatoform Disorders |
| D006963 | Hyperphagia |
| D012817 | Signs and Symptoms, Digestive |
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| ID | Term |
|---|---|
| D008559 | Memantine |
| ID | Term |
|---|---|
| D000547 | Amantadine |
| D000218 | Adamantane |
| D001952 | Bridged-Ring Compounds |
| D006844 | Hydrocarbons, Cyclic |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| 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. | One subject completed. The remaining two subjects' last observation was carried forward. | Posted | Mean | Standard Deviation | units on a scale | Baseline to 12 weeks |
|
|
|
| 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). | One subject completed. The remaining two subjects' last observation was carried forward. | Posted | Mean | Standard Deviation | units on a scale | Baseline to 12 weeks |
|
|
|
| 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. | One subject completed. The remaining two subjects' last observation was carried forward. | Posted | Mean | Standard Deviation | units on a scale | Baseline to 12 weeks |
|
|
|
| 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. | This scale was only administered to participants with Body Dysmorphic Disorder. No participants with BDD completed the Baseline Visit and, therefore, no results were available to analyze. | Posted | Baseline to 12 weeks |
|
|
| 0 |
| 3 |
| 3 |
| 3 |
| Headache | General disorders |
|
| Pain when closing eyes | Eye disorders |
|
| Constant eye pressure | Eye disorders |
|
| Eye pain | Eye disorders |
|
| Cough | Respiratory, thoracic and mediastinal disorders |
|
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |