Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2025-12-25 @ 11:11 PM
Study NCT ID:
NCT01043367
Status:
COMPLETED
Last Update Posted:
2011-03-08
First Post:
2010-01-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Deprexil in Subjects With Signs and Symptoms of Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-03', 'completionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-03-06', 'studyFirstSubmitDate': '2010-01-05', 'studyFirstSubmitQcDate': '2010-01-05', 'lastUpdatePostDateStruct': {'date': '2011-03-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-01-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Functional capabilities at week 24 (end of the treatment)', 'timeFrame': '24 weeks'}, {'measure': 'Social capabilities at week 24 (end of the treatment)', 'timeFrame': '24 weeks'}, {'measure': 'Psycho-affective capabilities at week 24 (end of the treatment)', 'timeFrame': '24 weeks'}, {'measure': 'Behavioral capabilities at week 24 (end of the treatment)', 'timeFrame': '24 weeks'}], 'secondaryOutcomes': [{'measure': 'Tolerability to Deprexil at week 24 (end of the treatment)', 'timeFrame': '24 weeks'}, {'measure': 'Symptoms of depression at week 24 (end of the treatment)', 'timeFrame': '24 weeks'}, {'measure': 'Signs of depression at week 24 (end of the treatment)', 'timeFrame': '24 weeks'}, {'measure': 'Clinical symptoms of baseline disease at 24 weeks (end of the treatment)', 'timeFrame': '24 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Depression', 'Dietary supplement', 'Deprexil'], 'conditions': ['Depression']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to assess the efficacy of DEPREXIL administration in combination with relaxation psychotherapy in the treatment of patients with signs and symptoms of depression. The duration of this double-blind placebo controlled phase 3 clinical trial will be 24 weeks. The estimated number of persons to be recruited and randomized for the study is 200.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '59 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Mild or moderate symptoms and signs of depression for more than 3 months and less than 3 years of duration.\n* Signed informed consent\n\nExclusion Criteria:\n\n* Severe symptoms and signs of depression or Suicide proneness.\n* Pregnancy or breastfeeding\n* Receiving other experimental drug\n* Use of anti-depressive medication within 15 days'}, 'identificationModule': {'nctId': 'NCT01043367', 'briefTitle': 'Deprexil in Subjects With Signs and Symptoms of Depression', 'organization': {'class': 'INDUSTRY', 'fullName': 'Catalysis SL'}, 'officialTitle': 'Efficacy of Deprexil Administration in Subjects With Signs and Symptoms of Depression.', 'orgStudyIdInfo': {'id': 'CAT-0908-CU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': 'Deprexil', 'interventionNames': ['Dietary Supplement: Deprexil']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'B', 'description': 'Placebo', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Deprexil', 'type': 'DIETARY_SUPPLEMENT', 'description': 'One 600 mg Deprexil tablet (Orally administered) half an hour after each meal (breakfast, lunch and dinner), for 24 weeks. A 20 minutes relaxation psychotherapy will also be provided once a week.', 'armGroupLabels': ['A']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'One Placebo tablet (Orally administered) half an hour after each meal (breakfast, lunch and dinner), for 24 weeks. A 20 minutes relaxation psychotherapy will also be provided once a week.', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10400', 'city': 'Havana', 'state': 'La Habana', 'country': 'Cuba', 'facility': '"Heroes del Moncada" Polyclinic', 'geoPoint': {'lat': 23.13302, 'lon': -82.38304}}], 'overallOfficials': [{'name': 'Maria de la Concepción Valdivia Alarcón, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': '"Heroes del Moncada" Polyclinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Catalysis SL', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Maria de la Concepción Valdivia Alarcón', 'oldOrganization': '"Heroes del Moncada" Polyclinic'}}}}