Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2026-01-07 @ 9:23 PM
Study NCT ID:
NCT00519051
Status:
COMPLETED
Last Update Posted:
2007-08-21
First Post:
2007-08-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Randomized Clinical Trial for Depressed Mothers at Primary Care Level
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000928', 'term': 'Antidepressive Agents'}, {'id': 'D005473', 'term': 'Fluoxetine'}], 'ancestors': [{'id': 'D011619', 'term': 'Psychotropic Drugs'}, {'id': 'D002491', 'term': 'Central Nervous System Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D011437', 'term': 'Propylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 345}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-08', 'completionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-08-20', 'studyFirstSubmitDate': '2007-08-17', 'studyFirstSubmitQcDate': '2007-08-20', 'lastUpdatePostDateStruct': {'date': '2007-08-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-08-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'depressive symptoms measured with the HDRS', 'timeFrame': 'at 3,6 and 12 months after randomization'}], 'secondaryOutcomes': [{'measure': 'quality of life measured with the SF-36', 'timeFrame': 'at 3,6 and 12 months after randomization'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['depression', 'primary care', 'pharmacotherapy'], 'conditions': ['Depression']}, 'referencesModule': {'references': [{'pmid': '17657327', 'type': 'RESULT', 'citation': 'Fritsch R, Araya R, Solis J, Montt E, Pilowsky D, Rojas G. [A randomized trial of pharmacotherapy with telephone monitoring to improve treatment of depression in primary care in Santiago, Chile]. Rev Med Chil. 2007 May;135(5):587-95. Epub 2007 Jul 9. Spanish.'}]}, 'descriptionModule': {'briefSummary': "A randomized clinical trial was carried out at primary care level in Santiago, Chile to compare a pharmacological intervention for depressed mothers controlled by phone from a central level (TM) and the usual treatment (TH) and its impact on children's mental health.\n\nHypothesis: pharmacological intervention for depression controlled by phone from a central level will be more effective than usual care in depressed mothers.", 'detailedDescription': "Aim:to compare a pharmacological intervention for depressed mothers controlled by phone from a central level (TM) and the usual treatment (TH) and its impact on children's mental health.\n\nMaterial and methods: A RCT wasw carried out at primary care clinics in Santiago.Sample:three hundred and forty five depressed women . One children of each mother was randomly selected. Women are randomly assigned to receive the usual therapy or a pharmacological intervention with periodical telephone contacts with medical collaboration personnel, to reinforce compliance with treatment and educate about the disease, for 6 months. Women were blindly evaluated at 3, 6 and 12 months with the Hamilton depression rating score (HDRS) and the SF-36 to assess depressive symptoms and quality of life, respectively; the Dyadic Adjustment Scale to assess marital adjustment.\n\nChild psychopathology was assessed with the Child Behavior Checklist (CBCL), the Brief Psychiatric Rating Scale for Children (BPRS-C), Screen for Child Anxiety Related Emotional Disorders(SCARED)and the Children's Depression Inventory."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* depressed mothers with al least one child aged 6-16\n\nExclusion Criteria:\n\n* currently treatment for depression,psychosis,bipolar depression,alcohol or drug abuse, gravidity.'}, 'identificationModule': {'nctId': 'NCT00519051', 'acronym': 'DMH', 'briefTitle': 'A Randomized Clinical Trial for Depressed Mothers at Primary Care Level', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Fondo Nacional de Desarrollo Científico y Tecnológico, Chile'}, 'officialTitle': 'Efectividad de la Farmacoterapia Monitorizada en Pacientes Deprimidas de la atención Primaria de Salud y su repercusión Sobre la Salud Mental de Sus Hijos', 'orgStudyIdInfo': {'id': '1040432'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'control group', 'description': 'patients can receive pharmacotherapy and psychotherapy and specialized treatment', 'interventionNames': ['Other: monitorized pharmacotherapy with antidepressants drugs (Fluoxetine)']}], 'interventions': [{'name': 'monitorized pharmacotherapy with antidepressants drugs (Fluoxetine)', 'type': 'OTHER', 'otherNames': ['usual care'], 'description': 'Fluoxetine oral,20-60 mg/day for 6 months with telephone monitorization', 'armGroupLabels': ['control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Santiago', 'state': 'Santiago Metropolitan', 'country': 'Chile', 'facility': 'CORESAM Conchali', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}], 'overallOfficials': [{'name': 'rosemarie fritsch, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Chile'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondo Nacional de Desarrollo Científico y Tecnológico, Chile', 'class': 'OTHER_GOV'}}}}