Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2025-12-26 @ 12:00 AM
Study NCT ID:
NCT00151294
Status:
TERMINATED
Last Update Posted:
2006-09-14
First Post:
2005-09-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Efficacy and Safety of Escitalopram for Depression in Multiple Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'id': 'D000342', 'term': 'Affective Symptoms'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 20}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2004-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-09', 'completionDateStruct': {'date': '2006-10'}, 'lastUpdateSubmitDate': '2006-09-12', 'studyFirstSubmitDate': '2005-09-06', 'studyFirstSubmitQcDate': '2005-09-07', 'lastUpdatePostDateStruct': {'date': '2006-09-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Escitalopram-treated MS patients will have greater reductions in their depressive symptom scores than patients randomized to placebo'}, {'measure': 'Adverse events for both groups will be similar'}], 'secondaryOutcomes': [{'measure': 'Escitalopram-treated emotionally labile patients with MS will have a greater reduction in emotional lability scores than those randomized to placebo.'}]}, 'conditionsModule': {'keywords': ['Depression (mild to moderate)', 'Affective symptoms', 'Emotional lability', 'Multiple Sclerosis'], 'conditions': ['Depression', 'Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': 'Emotionally labile, depressed participants with multiple sclerosis treated with escitalopram will have a greater reduction in emotional lability scores and in their psychological distress scores than those who are randomized to receive placebo.', 'detailedDescription': 'Patients with multiple sclerosis who are experiencing mood lability and symptoms of depression will be randomized to receive either escitalopram 10mg/day or placebo tablets for a period of 6 weeks. It is hypothesized that patients receiving medication will experience a greater normalization of their emotional instability and a greater reduction in their depressive symptoms at the end of the six-week trial than those who are not receiving medication.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of multiple sclerosis\n* Having mild to moderate depressive symptoms, with or without emotional lability\n* Experiencing psychological distress\n\nExclusion Criteria:\n\n* Meeting DSM-IV diagnostic criteria for Major Depressive Disorder or another Axis 1 diagnosis\n* Cognitive impairment\n* The presence of an unstable medical illness that might preclude completion of the study -'}, 'identificationModule': {'nctId': 'NCT00151294', 'briefTitle': 'The Efficacy and Safety of Escitalopram for Depression in Multiple Sclerosis', 'organization': {'class': 'OTHER', 'fullName': 'Weill Medical College of Cornell University'}, 'officialTitle': 'A Double-Blind, Placebo-Controlled Investigation Into the Safety and Efficacy of Escitalopram for Depression in Multiple Sclerosis', 'orgStudyIdInfo': {'id': 'LXP-MD 45'}, 'secondaryIdInfos': [{'id': '0410007546'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'escitalopram oxalate antidepressant', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10605', 'city': 'White Plains', 'state': 'New York', 'country': 'United States', 'facility': 'NewYork Presbyterian Hospital', 'geoPoint': {'lat': 41.03399, 'lon': -73.76291}}], 'overallOfficials': [{'name': 'Barnett S Meyers, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Weill Medical College of Cornell University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Weill Medical College of Cornell University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Forest Laboratories', 'class': 'INDUSTRY'}]}}}