Ignite Creation Date:
2025-12-24 @ 4:16 PM
Ignite Modification Date:
2026-01-03 @ 6:55 PM
Study NCT ID:
NCT00285766
Status:
COMPLETED
Last Update Posted:
2008-04-22
First Post:
2006-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety, Tolerability and Efficacy of the Transdermal System in Elderly Subjects With Major Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-08'}, 'statusVerifiedDate': '2008-04', 'completionDateStruct': {'date': '2005-07'}, 'lastUpdateSubmitDate': '2008-04-21', 'studyFirstSubmitDate': '2006-01-31', 'studyFirstSubmitQcDate': '2006-01-31', 'lastUpdatePostDateStruct': {'date': '2008-04-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-02-02', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Depression'], 'conditions': ['Major Depression']}, 'descriptionModule': {'briefSummary': 'Objective of this 16-week, open-label study is to assess the safety and tolerability of once daily application of three doses of STS during continuous dosing in the treatment of elderly subjects with major depression. Subjects will have study visits (clinic visits) at beginning of study (baseline) and study weeks 1, 3, 5, 8, 12, and 16.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '* Men/Women in good health 65 years or older\n* Ability to read, understand and sign study informed consent\n* Major depression- mild to severe based on rating scale'}, 'identificationModule': {'nctId': 'NCT00285766', 'briefTitle': 'Safety, Tolerability and Efficacy of the Transdermal System in Elderly Subjects With Major Depression', 'organization': {'class': 'INDUSTRY', 'fullName': 'Somerset Pharmaceuticals'}, 'officialTitle': 'A Phase III, Open-Label Study of the Safety, Tolerability and Efficacy of the Selegiline Transdermal System in Elderly Subjects With Major Depression', 'orgStudyIdInfo': {'id': 'S9303-P0204'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Selegiline Transdermal System', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '91910', 'city': 'Chula Vista', 'state': 'California', 'country': 'United States', 'facility': 'Mohammed Bari, M.D.', 'geoPoint': {'lat': 32.64005, 'lon': -117.0842}}, {'zip': '92108', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Charles Meredith, M.D.', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '94589', 'city': 'Upland', 'state': 'California', 'country': 'United States', 'facility': 'Daniel Zimbroff, M.D.', 'geoPoint': {'lat': 34.09751, 'lon': -117.64839}}, {'zip': '94589', 'city': 'Walnut Creek', 'state': 'California', 'country': 'United States', 'facility': 'Kathleen Toups, M.D.', 'geoPoint': {'lat': 37.90631, 'lon': -122.06496}}, {'zip': '33437', 'city': 'Boynton Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Abbey Strauss, M.D.', 'geoPoint': {'lat': 26.52535, 'lon': -80.06643}}, {'zip': '33154', 'city': 'Miami Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Barry Baumel, M.D.', 'geoPoint': {'lat': 25.79065, 'lon': -80.13005}}, {'zip': '33702', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': 'Margarita Nunez, M.D.', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '33710', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': 'Mildred Farmer, M.D.', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '33321', 'city': 'Tamarack', 'state': 'Florida', 'country': 'United States', 'facility': 'Larry Eisner, M.D.'}, {'zip': '32789', 'city': 'Winter Park', 'state': 'Florida', 'country': 'United States', 'facility': 'Andrew Cutler, M.D.', 'geoPoint': {'lat': 28.6, 'lon': -81.33924}}, {'zip': '30308', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Robert Riesenberg, M.D.', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '41042', 'city': 'Florence', 'state': 'Kentucky', 'country': 'United States', 'facility': 'James Hartford, M.D.', 'geoPoint': {'lat': 38.99895, 'lon': -84.62661}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Mitchel Kling, M.D.', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '73103', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Louise Beckett, M.D.', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '76309', 'city': 'Wichita Falls', 'state': 'Texas', 'country': 'United States', 'facility': 'Penny Barnhart, M.D.', 'geoPoint': {'lat': 33.91371, 'lon': -98.49339}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Somerset Pharmaceuticals', 'class': 'INDUSTRY'}}}}