Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2026-02-25 @ 8:30 PM
Study NCT ID:
NCT00106405
Status:
COMPLETED
Last Update Posted:
2012-03-05
First Post:
2005-03-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Evaluation of the Safety and Efficacy of Memantine in Patients With Acute Mania Associated With Bipolar I Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001714', 'term': 'Bipolar Disorder'}, {'id': 'D000087122', 'term': 'Mania'}], 'ancestors': [{'id': 'D000068105', 'term': 'Bipolar and Related Disorders'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-02'}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2005-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-01', 'studyFirstSubmitDate': '2005-03-24', 'studyFirstSubmitQcDate': '2005-03-24', 'lastUpdatePostDateStruct': {'date': '2012-03-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-03-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Young Mania Rating Scale (YMRS)'}, {'measure': 'Mania Rating Scale'}, {'measure': 'Clinical Global Impression'}, {'measure': 'Montgomery Asberg Depression Rating Scale'}, {'measure': 'Positive and Negative Syndrome Scale (PANSS)'}, {'measure': 'PANSS - Excited Component'}]}, 'conditionsModule': {'keywords': ['Bipolar I Disorder', 'Mania', 'Memantine HCl'], 'conditions': ['Bipolar Disorder']}, 'descriptionModule': {'briefSummary': 'Bipolar disorder affects 2.4 million adults in the USA between the ages of 18-65 and has considerable economic impact on our society. Bipolar mania accounts for 1 in 7 psychiatric emergencies and is associated with significant morbidity and mortality. The purpose of the study is to evaluate the safety and efficacy of open-label memantine in the acute management of adults with bipolar I disorder hospitalized for mania.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients must have a documented clinical diagnosis of bipolar I disorder and must be currently experiencing a manic or mixed episode.\n* Patients must be voluntarily hospitalized with a primary diagnosis of mania.\n\nExclusion Criteria:\n\n* Rapid cycling bipolar disorder.\n* Suicidal risk.\n* First manic episode.\n* ECT, clozapine or a depot neuroleptic in the past 3 months.\n* Substance dependence.\n* Known HIV infection.\n* Co-morbid serious, uncontrolled systemic illness.'}, 'identificationModule': {'nctId': 'NCT00106405', 'briefTitle': 'An Evaluation of the Safety and Efficacy of Memantine in Patients With Acute Mania Associated With Bipolar I Disorder', 'organization': {'class': 'INDUSTRY', 'fullName': 'Forest Laboratories'}, 'officialTitle': 'A Pilot Evaluation of the Safety and Efficacy of Memantine in Patients With Acute Mania Associated With Bipolar I Disorder', 'orgStudyIdInfo': {'id': 'MEM-MD-27'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Memantine HCl', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '91950', 'city': 'National City', 'state': 'California', 'country': 'United States', 'facility': 'Synergy Clinical Research Center', 'geoPoint': {'lat': 32.67811, 'lon': -117.0992}}, {'zip': '21204', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Sheppard Pratt Health System', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '63301', 'city': 'Saint Charles', 'state': 'Missouri', 'country': 'United States', 'facility': 'St. Charles Psychiatric Associates', 'geoPoint': {'lat': 38.78394, 'lon': -90.48123}}, {'zip': '45267-0559', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Psychiatric Professional Services, Inc.', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '77555-0197', 'city': 'Galveston', 'state': 'Texas', 'country': 'United States', 'facility': 'Rebecca Sealy Hospital', 'geoPoint': {'lat': 29.30135, 'lon': -94.7977}}, {'zip': '75062', 'city': 'Irving', 'state': 'Texas', 'country': 'United States', 'facility': 'University Hills Clinical Research', 'geoPoint': {'lat': 32.81402, 'lon': -96.94889}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Forest Laboratories', 'class': 'INDUSTRY'}}}}