Ignite Creation Date:
2025-12-25 @ 1:05 AM
Ignite Modification Date:
2026-02-26 @ 12:38 AM
Study NCT ID:
NCT02122393
Status:
COMPLETED
Last Update Posted:
2014-04-29
First Post:
2014-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Randomised Trial of Sertraline, Cognitive Behaviour Therapy & Combined Therapy for Postnatal Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020280', 'term': 'Sertraline'}, {'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}], 'ancestors': [{'id': 'D015057', 'term': '1-Naphthylamine'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2005-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-27', 'studyFirstSubmitDate': '2014-04-22', 'studyFirstSubmitQcDate': '2014-04-22', 'lastUpdatePostDateStruct': {'date': '2014-04-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Beck Depression Inventory', 'timeFrame': '24 weeks'}], 'secondaryOutcomes': [{'measure': 'Beck Anxiety Inventory', 'timeFrame': '24 weeks'}, {'measure': 'Parenting Stress Index', 'timeFrame': '24 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Depression', 'Anxiety']}, 'descriptionModule': {'briefSummary': 'Th purpose of this study is to determine whether dual psychological and pharmacological treatment is superior to either mono-therapy alone in the treatment of postnatal depression.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women with an infant \\> 2 months and \\< 8 months of age\n* Infant born after a full-term pregnancy\n* Infant born with no congenital abnormalities\n* Diagnosis of depression with postnatal onset according to the Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV).\n\nExclusion Criteria:\n\n* positive serum pregnancy test;\n* concurrent psychiatric disorder (excepting co-morbid anxiety);\n* recent history of antidepressant usage (within the last month);\n* history of major allergy or drug allergy;\n* history of substance abuse;\n* prior non-response to sertraline, or prior non-response to adequate trials of two selective serotonin reuptake inhibitors (SSRIs);\n* predisposition to headache, migraine or nausea;\n* tobacco habit in excess of 10 cigarettes per day;\n* caffeine consumption in excess of 6 cups of coffee/tea or cola-flavoured drinks per day;\n* ongoing dental work;\n* extreme levels of depression (psychotic);\n* suicidal intent;\n* participation in any medical trial within the previous three months;'}, 'identificationModule': {'nctId': 'NCT02122393', 'briefTitle': 'A Randomised Trial of Sertraline, Cognitive Behaviour Therapy & Combined Therapy for Postnatal Depression', 'organization': {'class': 'OTHER', 'fullName': 'University of Melbourne'}, 'officialTitle': 'A Randomised, Controlled Evaluation of Sertraline, Cognitive Behaviour Therapy & Combined Therapy for Postnatal Depression', 'orgStudyIdInfo': {'id': 'H2001/01263'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Sertraline', 'interventionNames': ['Drug: Sertraline']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cognitive Behavioural Therapy', 'interventionNames': ['Behavioral: Cognitive Behavioural Therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Combined Therapy', 'interventionNames': ['Drug: Sertraline', 'Behavioral: Cognitive Behavioural Therapy']}], 'interventions': [{'name': 'Sertraline', 'type': 'DRUG', 'armGroupLabels': ['Combined Therapy', 'Sertraline']}, {'name': 'Cognitive Behavioural Therapy', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Cognitive Behavioural Therapy', 'Combined Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3081', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Austin Health', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}], 'overallOfficials': [{'name': 'Jeannette Milgrom, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Melbourne'}, {'name': 'Alan W Gemmill, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Austin Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Melbourne', 'class': 'OTHER'}, 'collaborators': [{'name': 'Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jeannette Milgrom', 'investigatorAffiliation': 'University of Melbourne'}}}}