Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2025-12-27 @ 11:15 AM
Study NCT ID:
NCT02262156
Status:
COMPLETED
Last Update Posted:
2015-03-30
First Post:
2014-10-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CBT Versus Selective Serotonin Reuptake Inhibitor For Treatment Of Depression In Temporal Lobe Epilepsy Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D004833', 'term': 'Epilepsy, Temporal Lobe'}, {'id': 'D004827', 'term': 'Epilepsy'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D004828', 'term': 'Epilepsies, Partial'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000073376', 'term': 'Epileptic Syndromes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}, {'id': 'D017367', 'term': 'Selective Serotonin Reuptake Inhibitors'}, {'id': 'D000928', 'term': 'Antidepressive Agents'}], 'ancestors': [{'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D014179', 'term': 'Neurotransmitter Uptake Inhibitors'}, {'id': 'D049990', 'term': 'Membrane Transport Modulators'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D018377', 'term': 'Neurotransmitter Agents'}, {'id': 'D018490', 'term': 'Serotonin Agents'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D011619', 'term': 'Psychotropic Drugs'}, {'id': 'D002491', 'term': 'Central Nervous System Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-27', 'studyFirstSubmitDate': '2014-10-07', 'studyFirstSubmitQcDate': '2014-10-09', 'lastUpdatePostDateStruct': {'date': '2015-03-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Beck Depression Inventory score', 'timeFrame': 'baseline, 6 weeks and 12 weeks'}], 'secondaryOutcomes': [{'measure': 'Quality of Life in Epilepsy Scale', 'timeFrame': 'baseline, 6 weeks and 12 weeks', 'description': 'the quality of life in epilepsy scale measures the patients perceived quality of life. Higher score indicates better quality of life. score goes from 0 to 100'}, {'measure': 'Hospital anxiety and depression scale (HADS)', 'timeFrame': 'baseline, 4weeks and 12 weeks', 'description': 'the HADS measures severity of symptoms of anxiety and depression. Lower scores indicates less symptoms'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cognitive Behavioral Therapy', 'Selective serotonin reuptake inhibitor', 'depression', 'epilepsy'], 'conditions': ['Depression', 'Epilepsy, Temporal Lobe']}, 'referencesModule': {'references': [{'pmid': '33860531', 'type': 'DERIVED', 'citation': 'Maguire MJ, Marson AG, Nevitt SJ. Antidepressants for people with epilepsy and depression. Cochrane Database Syst Rev. 2021 Apr 16;4(4):CD010682. doi: 10.1002/14651858.CD010682.pub3.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to compare the effect of group-cognitive-behavioral therapy (CBT)versus treatment as usual with the selective serotonin reuptake inhibitor sertraline, in patients with diagnosis of temporal lobe epilepsy (TLE) and depressive disorder.', 'detailedDescription': 'patients with temporal lobe epilepsy and depression will be enrolled into one of two treatment modality. The first group will receive 12 group cognitive behavioral sessions. CBT is a psychotherapy focused on the recognition and change of distorted thoughts and maladaptive behaviors.\n\nThe second group will receive treatment with the selective serotonin reuptake inhibitor sertraline or citalopram for 12 weeks. This antidepressant is wide used to treat depression in patients with TLE.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* With Major depressive disorder according to criteria from the fourth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV)\n* Diagnosed with TLE according to the criteria of the International League Against Epilepsy\n* Literates had sign an informed consent\n* Patients on antidepressant treatments will be allowed to participate only if they had been at stable doses for more than 8 weeks and still show signs of significant depression\n\nExclusion Criteria:\n\n* Patients with high risk of suicide who required hospitalization\n* Patients who abused or are dependent on drugs\n* Those with a history of head trauma six months prior to the interview\n* Patients who have any condition that would prevent them from understanding the study or the psychotherapeutic process, such as mental retardation, psychosis, delirium, dementia, etc\n* Patients who have previously received CBT\n* Patients who have started, an antidepressant drug the last 8 weeks'}, 'identificationModule': {'nctId': 'NCT02262156', 'acronym': 'CBTvsSSRI', 'briefTitle': 'CBT Versus Selective Serotonin Reuptake Inhibitor For Treatment Of Depression In Temporal Lobe Epilepsy Patients', 'organization': {'class': 'OTHER', 'fullName': 'El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez'}, 'officialTitle': 'Treatment Of Depression In Patients With Temporal Lobe Epilepsy: Comparative Study Of Cognitive Behavioral Therapy Vs. Selective Serotonin Reuptake Inhibitors', 'orgStudyIdInfo': {'id': '49/06'}, 'secondaryIdInfos': [{'id': 'U1111-1158-3147', 'type': 'OTHER', 'domain': 'WHO UTN'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cognitive behavioral Therapy', 'description': 'CBT program to be used in group modality that focused on managing symptoms of depression in patients with epilepsy.\n\n12 CBT sessions, consisting of one weekly 90-minute session for 12 consecutive weeks.', 'interventionNames': ['Other: Cognitive behavioral therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Selective serotonin euptake inhibitor', 'description': 'Patients will receive a SSRI (sertraline or citalopram) for 12 weeks. Dose will be adjusted every 4 weeks according to medical criteria.', 'interventionNames': ['Drug: SSRI']}], 'interventions': [{'name': 'Cognitive behavioral therapy', 'type': 'OTHER', 'otherNames': ['CBT'], 'description': 'The CBT group will receive 12 weekly 90-minute sessions. Each session will be given in group form by one certified CBT therapist and one neuropsychiatrist in training on group therapy.\n\nThe CBT structure include psychoeducation, addressing dysfunctional thoughts and maladaptive behaviors; problem solving techniques, assertiveness, coping strategies and depression relapse prevention', 'armGroupLabels': ['Cognitive behavioral Therapy']}, {'name': 'SSRI', 'type': 'DRUG', 'otherNames': ['selective serotonin reuptake inhibitor', 'antidepressant'], 'description': 'Patients will receive the "treatment as usual" with a SSRI: sertraline or citalopram. In patients already taking antidepressants for more than 8 weeks before enrollment but still experiencing depressive symptoms, treatment could be optimized either by augmenting the dose of his antidepressant or by changing to one of the SSRI mentioned.', 'armGroupLabels': ['Selective serotonin euptake inhibitor']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14269', 'city': 'México', 'state': 'D.f.', 'country': 'Mexico', 'facility': 'Instituto Nacional de Neurología y Neurocirugía MVS', 'geoPoint': {'lat': 31.00435, 'lon': -108.15213}}], 'overallOfficials': [{'name': 'Daniel Crail-Melendez, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Md', 'investigatorFullName': 'Edgar Daniel Crail Melendez', 'investigatorAffiliation': 'El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez'}}}}