Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2025-12-25 @ 9:20 PM
Study NCT ID:
NCT00739856
Status:
COMPLETED
Last Update Posted:
2008-08-22
First Post:
2008-08-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Use of Electroconvulsive Therapy (ECT) in Chronic, Severe, Treatment Resistant Posttraumatic Stress Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}], 'ancestors': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004565', 'term': 'Electroconvulsive Therapy'}], 'ancestors': [{'id': 'D003295', 'term': 'Convulsive Therapy'}, {'id': 'D013000', 'term': 'Psychiatric Somatic Therapies'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D004597', 'term': 'Electroshock'}, {'id': 'D011580', 'term': 'Psychological Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-08', 'lastUpdateSubmitDate': '2008-08-21', 'studyFirstSubmitDate': '2008-08-20', 'studyFirstSubmitQcDate': '2008-08-21', 'lastUpdatePostDateStruct': {'date': '2008-08-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-08-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinician-Administered Posttraumatic Stress Disorder Scale (CAPS) SCORE'}], 'secondaryOutcomes': [{'measure': 'Montgomery-Asberg Depression Rating Scale score', 'timeFrame': 'baseline, 48 hrs post 3rd, 6th ECT'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['posttraumatic stress disorder', 'electroconvulsive therapy', 'medication refractoriness'], 'conditions': ['Posttraumatic Stress Disorder']}, 'referencesModule': {'references': [{'pmid': '20633428', 'type': 'DERIVED', 'citation': 'Margoob MA, Ali Z, Andrade C. Efficacy of ECT in chronic, severe, antidepressant- and CBT-refractory PTSD: an open, prospective study. Brain Stimul. 2010 Jan;3(1):28-35. doi: 10.1016/j.brs.2009.04.005. Epub 2009 May 27.'}]}, 'descriptionModule': {'briefSummary': 'Post Traumatic Stress Disorder is a chronic debilitating illness and few treatment options have demonstrated effectiveness. The study will look at the use of electroconvulsive therapy for the treatment of Post Traumatic Stress disorder in patients who have not responded to multiple antidepressants or cognitive behavioral therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of PTSD\n* Treatment resistance to 4 different antidepressants from 3 different classes\n* Treatment resistance to CBT\n* Severe PTSD\n\nExclusion Criteria:\n\n* Significant substance abuse\n* Pregnancy\n* History of Traumatic Brain Injury\n* Unstable comorbid medical illness\n* Organic brain syndrome'}, 'identificationModule': {'nctId': 'NCT00739856', 'briefTitle': 'Use of Electroconvulsive Therapy (ECT) in Chronic, Severe, Treatment Resistant Posttraumatic Stress Disorder', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Government Medical College Srinagar'}, 'officialTitle': 'Efficacy of ECT in Chronic, Severe, Antidepressant- And CBT-Refractory Posttraumatic Stress Disorder: An Open, Prospective Study', 'orgStudyIdInfo': {'id': 'GMCPTSD_ECT2005'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Electroconvulsive Therapy', 'type': 'PROCEDURE', 'description': 'ECT was administered using the MECTA-SR1 apparatus. The current amplitude was 800 mA, pulse width was 1.5 ms, and pulse frequency was 50 Hz. Stimulus duration was increased as required to elicit an adequate seizure, defined as at least 25 s with EEG monitoring. The ECT course was fixed, and comprised 6 treatments administered with bitemporal electrode placement at a twice-weekly frequency'}]}, 'contactsLocationsModule': {'locations': [{'zip': '190003', 'city': 'Srinagar', 'state': 'Jammu and Kashmir', 'country': 'India', 'facility': 'Government Hospital for Psychiatric Disease', 'geoPoint': {'lat': 34.08565, 'lon': 74.80555}}], 'overallOfficials': [{'name': 'Mushtaq Margoob, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Government Medical College Srinagar'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Government Medical College Srinagar', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Government Psychiatric Diseases Hospital, Srinagar', 'class': 'UNKNOWN'}]}}}