Ignite Creation Date:
2025-12-26 @ 10:32 AM
Ignite Modification Date:
2025-12-29 @ 12:17 PM
Study NCT ID:
NCT01038128
Status:
COMPLETED
Last Update Posted:
2015-05-04
First Post:
2009-12-21
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
An Open Label Trial of Memantine in the Treatment of Bulimia Nervosa and Body Dysmorphic Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D052018', 'term': 'Bulimia Nervosa'}, {'id': 'D057215', 'term': 'Body Dysmorphic Disorders'}, {'id': 'D002032', 'term': 'Bulimia'}, {'id': 'D001068', 'term': 'Feeding and Eating Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D013001', 'term': 'Somatoform Disorders'}, {'id': 'D006963', 'term': 'Hyperphagia'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008559', 'term': 'Memantine'}], 'ancestors': [{'id': 'D000547', 'term': 'Amantadine'}, {'id': 'D000218', 'term': 'Adamantane'}, {'id': 'D001952', 'term': 'Bridged-Ring Compounds'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'eryan@mclean.harvard.edu', 'phone': '617-855-2984', 'title': 'Study Coordinator', 'organization': 'McLean Hospital'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Memantine', 'description': 'Memantine, 10-40 mg daily', 'otherNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Pain when closing eyes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders'}, {'term': 'Constant eye pressure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Binge Eating and Self-induced Vomiting Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Memantine', 'description': 'Number of Binge Eating and Purging Episodes at Baseline and Endpoint'}], 'classes': [{'title': 'Binge Eating Baseline', 'categories': [{'measurements': [{'value': '20.67', 'spread': '14.74', 'groupId': 'OG000'}]}]}, {'title': 'Binge Eating Endpoint', 'categories': [{'measurements': [{'value': '31.33', 'spread': '35.25', 'groupId': 'OG000'}]}]}, {'title': 'Purging Baseline', 'categories': [{'measurements': [{'value': '21.67', 'spread': '27.30', 'groupId': 'OG000'}]}]}, {'title': 'Purging Endpoint', 'categories': [{'measurements': [{'value': '36.67', 'spread': '54.93', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 12 weeks', 'description': 'Number of self-reported binge eating and self-induced vomiting episodes during the week prior to the Baseline and Endpoint Visits.', 'unitOfMeasure': 'number of episodes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "One subject completed. The remaining two subjects' last observation was carried forward."}, {'type': 'PRIMARY', 'title': 'Ratings of Eating Pathology', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Memantine', 'description': 'Ratings at Baseline and Endpoint'}], 'classes': [{'title': 'Baseline Data', 'categories': [{'measurements': [{'value': '101.33', 'spread': '71.07', 'groupId': 'OG000'}]}]}, {'title': 'Endpoint Data', 'categories': [{'measurements': [{'value': '38.67', 'spread': '30.27', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 12 weeks', 'description': '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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "One subject completed. The remaining two subjects' last observation was carried forward."}, {'type': 'PRIMARY', 'title': 'Clinical Global Impression Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Memantine', 'description': 'Ratings at Baseline and Endpoint'}], 'classes': [{'title': 'Baseline Data', 'categories': [{'measurements': [{'value': '5', 'spread': '0', 'groupId': 'OG000'}]}]}, {'title': 'Endpoint Data', 'categories': [{'measurements': [{'value': '4', 'spread': '1.41', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 12 weeks', 'description': '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).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "One subject completed. The remaining two subjects' last observation was carried forward."}, {'type': 'PRIMARY', 'title': 'Body Dysmorphic Disorder Version of the Yale Brown Obsessive Compulsive Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Memantine', 'description': 'Ratings at Baseline and Endpoint'}], 'classes': [{'title': 'Baseline Data', 'categories': [{'measurements': [{'value': '57.67', 'spread': '0.58', 'groupId': 'OG000'}]}]}, {'title': 'Endpoint Data', 'categories': [{'measurements': [{'value': '48.67', 'spread': '6.51', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 12 weeks', 'description': 'The scale ranges from 0 to 91 units, with 0 representing the least ill and 91 representing the most ill.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "One subject completed. The remaining two subjects' last observation was carried forward."}, {'type': 'PRIMARY', 'title': 'Brown Assessments of Belief Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline Data', 'description': 'Ratings at Baseline and Endpoint.'}], 'timeFrame': 'Baseline to 12 weeks', 'description': 'The range for this scale is 0 to 28 units, with 0 representing the least ill and 28 representing the most ill.', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Memantine', 'description': 'Memantine, 10-40 mg daily'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'Baseline Visit', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Memantine', 'description': 'Memantine, 10-40 mg daily'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '41.5', 'spread': '18.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-13', 'studyFirstSubmitDate': '2009-12-21', 'resultsFirstSubmitDate': '2012-03-19', 'studyFirstSubmitQcDate': '2009-12-21', 'lastUpdatePostDateStruct': {'date': '2015-05-04', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-05-09', 'studyFirstPostDateStruct': {'date': '2009-12-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-06-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Binge Eating and Self-induced Vomiting Episodes', 'timeFrame': 'Baseline to 12 weeks', 'description': 'Number of self-reported binge eating and self-induced vomiting episodes during the week prior to the Baseline and Endpoint Visits.'}, {'measure': 'Ratings of Eating Pathology', 'timeFrame': 'Baseline to 12 weeks', 'description': '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.'}, {'measure': 'Clinical Global Impression Scale', 'timeFrame': 'Baseline to 12 weeks', 'description': '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).'}, {'measure': 'Body Dysmorphic Disorder Version of the Yale Brown Obsessive Compulsive Scale', 'timeFrame': 'Baseline to 12 weeks', 'description': 'The scale ranges from 0 to 91 units, with 0 representing the least ill and 91 representing the most ill.'}, {'measure': 'Brown Assessments of Belief Scale', 'timeFrame': 'Baseline to 12 weeks', 'description': 'The range for this scale is 0 to 28 units, with 0 representing the least ill and 28 representing the most ill.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Bulimia nervosa', 'Bulimia', 'Body dysmorphic disorder', 'Eating disorders', 'Body image', 'Binge eating', 'purging'], 'conditions': ['Bulimia Nervosa', 'Body Dysmorphic Disorder']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nWe 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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria: Bulimia Nervosa\n\n* 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).\n* 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.\n* Male or Female between 18 and 65 years of age, inclusive.\n* 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.\n* Participants must have observed a designated washout period of at least seven days or a period equal to five half-lives of prohibited medications.\n* Participants must be able to take oral medication, adhere to the medication regimens, and be willing to return for regular visits.\n* Participants must be able and willing to read and comprehend written instructions and comprehend and complete all scales and questionnaires required by the protocol.\n* 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.\n\nInclusion Criteria: Body Dysmorphic Disorder\n\nInclusion criteria for participants with body dysmorphic disorder are identical to those for bulimia nervosa above, with the following differences in the first two criteria:\n\n* Participants must meet DSM-IV criteria for a current diagnosis of body dysmorphic disorder as determined by the SCID.\n* 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.\n\nExclusion Criteria for both Bulimia Nervosa and Body Dysmorphic Disorder:\n\n* Participants with a lifetime diagnosis of schizophrenia, other psychotic disorder, or bipolar disorder as defined by DSM-IV and supported by the SCID.\n* 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.\n* Participants judged clinically to be at suicidal or homicidal risk by the study physician.\n* 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.\n* Participants meeting DSM-IV criteria for anorexia nervosa within 3 months prior to the screening visit.\n* Participants with a current DSM-IV diagnosis of an organic mental disorder.\n* 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.\n* Participants who display a positive urine screen for drugs of abuse (phencyclidine, cocaine, amphetamines, tetrahydrocannabinol, and opiates) at the screening visit.\n* Participants who have previously received memantine for any reason.\n* Participants who have received an investigational medication within 30 days of the screening visit.\n* Participants who are pregnant or lactating.\n* Participants with a body mass index (BMI) less than 18.5 or greater than 35.\n* Participants who have abused ipecac as a method of purging within the past 2 years.\n* Participants who exhibit a serum potassium level of less than 3.0 mEq/L.\n* Participants with thyroid-stimulating hormone concentrations outside the range of 0.5-5.0 lU/mL.\n* Participants with clinically significant or unstable medical conditions\n* 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\n* 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."}, 'identificationModule': {'nctId': 'NCT01038128', 'briefTitle': 'An Open Label Trial of Memantine in the Treatment of Bulimia Nervosa and Body Dysmorphic Disorder', 'organization': {'class': 'OTHER', 'fullName': 'Mclean Hospital'}, 'officialTitle': 'Antiglutamatergic Treatment of Bulimia Nervosa and Body Dysmorphic Disorder: An Open-Label Trial of Memantine', 'orgStudyIdInfo': {'id': '2009-P-001901'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Memantine', 'description': 'Memantine, 10-40 mg daily', 'interventionNames': ['Drug: Memantine']}], 'interventions': [{'name': 'Memantine', 'type': 'DRUG', 'otherNames': ['Namenda'], 'description': 'Drug: Memantine, 10-40 mg daily', 'armGroupLabels': ['Memantine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02478', 'city': 'Belmont', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'McLean Hospital', 'geoPoint': {'lat': 42.39593, 'lon': -71.17867}}], 'overallOfficials': [{'name': 'James I Hudson, M.D., Sc.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mclean Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mclean Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Psychiatry, Harvard Medical School', 'investigatorFullName': 'James I. Hudson, MD', 'investigatorAffiliation': 'Mclean Hospital'}}}}