Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 10:50 PM
Study NCT ID:
NCT01034267
Status:
COMPLETED
Last Update Posted:
2012-08-17
First Post:
2009-12-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety Study of F2695 SR in Major Depressive Disorder
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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 828}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'lastUpdateSubmitDate': '2012-08-15', 'studyFirstSubmitDate': '2009-12-16', 'studyFirstSubmitQcDate': '2009-12-16', 'lastUpdatePostDateStruct': {'date': '2012-08-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse events, clinical laboratory tests, vital sign measurements, electrocardiograms, physical examinations, Columbia-Suicide Severity Rating Scale', 'timeFrame': '48 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Depression', 'Major Depressive Disorder'], 'conditions': ['Major Depressive Disorder']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the long- term safety of F2695-SR in the treatment of adults with major depressive disorder.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Completed 1 of the lead-in studies LVM-MD-01, LVM-MD-02, or LVM-MD-03\n* Have normal examination findings at the final visit of the lead-in study\n* Have a negative serum pregnancy test at the final visit of the lead-in study if a woman of child-bearing potential\n\nExclusion Criteria:\n\n* Any exclusionary psychiatric or medical condition that developed during the lead in study\n* Patients considered a suicide risk\n* Women who are pregnant, breastfeeding, or planning to become during the study OR are sexually active and not currently using a medically acceptable method of contraception'}, 'identificationModule': {'nctId': 'NCT01034267', 'acronym': 'LVM-MD-04', 'briefTitle': 'Safety Study of F2695 SR in Major Depressive Disorder', 'organization': {'class': 'INDUSTRY', 'fullName': 'Forest Laboratories'}, 'officialTitle': 'A Long-Term, Open-label Extension Study of F2695 SR in Adult Patients With Major Depressive Disorder', 'orgStudyIdInfo': {'id': 'LVM-MD-04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': '(Open-label) F2695 SR capsules, oral administration, once daily, flexible dosing', 'interventionNames': ['Drug: F2695 SR']}], 'interventions': [{'name': 'F2695 SR', 'type': 'DRUG', 'description': 'Drug F2695 SR (flexible dose) to be given orally in capsule form once daily', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36305', 'city': 'Dothan', 'state': 'Alabama', 'country': 'United States', 'facility': 'Forest Investigative Site 55', 'geoPoint': {'lat': 31.22323, 'lon': -85.39049}}, {'zip': '85254', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Forest Investigative Site 29', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '90210', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'Forest Investigative Site 31', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '92626', 'city': 'Costa Mesa', 'state': 'California', 'country': 'United States', 'facility': 'Forest Investigative Site 3', 'geoPoint': {'lat': 33.64113, 'lon': -117.91867}}, {'zip': '91316', 'city': 'Encino', 'state': 'California', 'country': 'United States', 'facility': 'Forest Investigative Site 12', 'geoPoint': {'lat': 34.15917, 'lon': -118.50119}}, {'zip': '92025', 'city': 'Escondido', 'state': 'California', 'country': 'United States', 'facility': 'Forest Investigative Site 6', 'geoPoint': {'lat': 33.11921, 'lon': -117.08642}}, {'zip': '92056', 'city': 'Oceanside', 'state': 'California', 'country': 'United States', 'facility': 'Forest Investigative Site 22', 'geoPoint': {'lat': 33.19587, 'lon': -117.37948}}, {'zip': '91403', 'city': 'Sherman Oaks', 'state': 'California', 'country': 'United States', 'facility': 'Forest Investigative Site 38', 'geoPoint': {'lat': 34.15112, 'lon': -118.44925}}, {'zip': '80204', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Forest Investigative Site 36', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '80239', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Forest Investigative Site 28', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '80130', 'city': 'Highlands Ranch', 'state': 'Colorado', 'country': 'United States', 'facility': 'Forest Investigative Site 65', 'geoPoint': {'lat': 39.55388, 'lon': -104.96943}}, {'zip': '06416', 'city': 'Cromwell', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Forest Investigative Site 30', 'geoPoint': {'lat': 41.5951, 'lon': -72.64537}}, {'zip': '33431', 'city': 'Boca Raton', 'state': 'Florida', 'country': 'United States', 'facility': 'Forest Investigative Site 57', 'geoPoint': {'lat': 26.35869, 'lon': -80.0831}}, {'zip': '33432', 'city': 'Boca Raton', 'state': 'Florida', 'country': 'United States', 'facility': 'Forest Investigative Site 60', 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33.749, 'lon': -84.38798}}, {'zip': '30080', 'city': 'Smyrna', 'state': 'Georgia', 'country': 'United States', 'facility': 'Forest Investigative Site 66', 'geoPoint': {'lat': 33.88399, 'lon': -84.51438}}, {'zip': '60634', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Forest Investigative Site 33', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60169', 'city': 'Hoffman Estates', 'state': 'Illinois', 'country': 'United States', 'facility': 'Forest Investigative Site 23', 'geoPoint': {'lat': 42.04281, 'lon': -88.0798}}, {'zip': '60523', 'city': 'Oak Brook', 'state': 'Illinois', 'country': 'United States', 'facility': 'Forest Investigative Site 50', 'geoPoint': {'lat': 41.83281, 'lon': -87.92895}}, {'zip': '46260', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Forest Investigative Site 63', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '66206', 'city': 'Prairie Village', 'state': 'Kansas', 'country': 'United States', 'facility': 'Forest Investigative Site 71', 'geoPoint': {'lat': 38.99167, 'lon': -94.63357}}, {'zip': '67206', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'Forest Investigative Site 5', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '71104', 'city': 'Shreveport', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Forest Investigative Site 52', 'geoPoint': {'lat': 32.52515, 'lon': -93.75018}}, {'zip': '21285', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Forest Investigative Site 1', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21061', 'city': 'Glen Burnie', 'state': 'Maryland', 'country': 'United States', 'facility': 'Forest Investigative Site 2', 'geoPoint': {'lat': 39.16261, 'lon': -76.62469}}, {'zip': '20852', 'city': 'Rockville', 'state': 'Maryland', 'country': 'United States', 'facility': 'Forest Investigative Site 37', 'geoPoint': {'lat': 39.084, 'lon': -77.15276}}, {'zip': '02721', 'city': 'Fall River', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Forest Investigative Site 32', 'geoPoint': {'lat': 41.70149, 'lon': -71.15505}}, {'zip': '48824', 'city': 'East Lansing', 'state': 'Michigan', 'country': 'United States', 'facility': 'Forest Investigative Site 15', 'geoPoint': {'lat': 42.73698, 'lon': -84.48387}}, {'zip': '08002', 'city': 'Cherry Hill', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Forest Investigative Site 35', 'geoPoint': {'lat': 39.93484, 'lon': -75.03073}}, {'zip': '08046', 'city': 'Willingboro', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Forest Investigative Site 21', 'geoPoint': {'lat': 40.02789, 'lon': -74.86905}}, {'zip': '11214', 'city': 'Brooklyn', 'state': 'New York', 'country': 'United States', 'facility': 'Forest Investigative Site 51', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}, {'zip': '11235', 'city': 'Brooklyn', 'state': 'New York', 'country': 'United States', 'facility': 'Forest Investigative Site 42', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}, {'zip': '10549', 'city': 'Mount Kisco', 'state': 'New York', 'country': 'United States', 'facility': 'Forest Investigative Site 4', 'geoPoint': {'lat': 41.20426, 'lon': -73.72708}}, {'zip': '10003', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Forest Investigative Site 16', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Forest Investigative Site 39', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10312', 'city': 'Staten Island', 'state': 'New York', 'country': 'United States', 'facility': 'Forest Investigative Site 9', 'geoPoint': {'lat': 40.56233, 'lon': -74.13986}}, {'zip': '27607', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Forest Investigative Site 46', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '44718', 'city': 'Canton', 'state': 'Ohio', 'country': 'United States', 'facility': 'Forest Investigative Site 25', 'geoPoint': {'lat': 40.79895, 'lon': -81.37845}}, {'zip': '45408', 'city': 'Dayton', 'state': 'Ohio', 'country': 'United States', 'facility': 'Forest Investigative Site 10', 'geoPoint': {'lat': 39.75895, 'lon': -84.19161}}, {'zip': '73112', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Forest Investigative Site 56', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '73112', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Forest Investigative Site 67', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '97210', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Forest Investigative Site 40', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '97301', 'city': 'Salem', 'state': 'Oregon', 'country': 'United States', 'facility': 'Forest Investigative Site 58', 'geoPoint': {'lat': 44.9429, 'lon': -123.0351}}, {'zip': '18104', 'city': 'Allentown', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Forest Investigative Site 54', 'geoPoint': {'lat': 40.60843, 'lon': -75.49018}}, {'zip': '19063', 'city': 'Media', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Forest Investigative Site 14', 'geoPoint': {'lat': 39.91678, 'lon': -75.38769}}, {'zip': '19401', 'city': 'Norristown', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Forest Investigative Site 43', 'geoPoint': {'lat': 40.1215, 'lon': -75.3399}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Forest Investigative Site 24', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '02865', 'city': 'Lincoln', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Forest Investigative Site 44', 'geoPoint': {'lat': 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States', 'facility': 'Forest Investigative Site 8', 'geoPoint': {'lat': 43.62424, 'lon': -72.51843}}, {'zip': '23452', 'city': 'Virginia Beach', 'state': 'Virginia', 'country': 'United States', 'facility': 'Forest Investigative Site 68', 'geoPoint': {'lat': 36.85293, 'lon': -75.97799}}, {'zip': '98007', 'city': 'Bellevue', 'state': 'Washington', 'country': 'United States', 'facility': 'Forest Investigative Site 19', 'geoPoint': {'lat': 47.61038, 'lon': -122.20068}}, {'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Forest Investigative Site 41', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '99204', 'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'facility': 'Forest Investigative Site 69', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}], 'overallOfficials': [{'name': 'Giovana Forrero, MA', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Forest Research Institute, a subsidiary of Forest Laboratories Inc'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Forest Laboratories', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}