Ignite Creation Date:
2025-12-24 @ 12:42 PM
Ignite Modification Date:
2025-12-28 @ 5:06 AM
Study NCT ID:
NCT00362661
Status:
TERMINATED
Last Update Posted:
2010-01-12
First Post:
2006-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Low-dose Cortisol in Chronic 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': 'D006854', 'term': 'Hydrocortisone'}], 'ancestors': [{'id': 'D011282', 'term': 'Pregnenediones'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D015062', 'term': '11-Hydroxycorticosteroids'}, {'id': 'D006889', 'term': 'Hydroxycorticosteroids'}, {'id': 'D000305', 'term': 'Adrenal Cortex Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D015065', 'term': '17-Hydroxycorticosteroids'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'whyStopped': 'Recruitment: Insufficient number of patients eligible for enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-01', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-01-11', 'studyFirstSubmitDate': '2006-08-09', 'studyFirstSubmitQcDate': '2006-08-09', 'lastUpdatePostDateStruct': {'date': '2010-01-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-08-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CAPS CGI', 'timeFrame': '1 year'}]}, 'conditionsModule': {'keywords': ['PTSD', 'cortisol', 'memory', 'treatment'], 'conditions': ['Posttraumatic Stress Disorder']}, 'referencesModule': {'references': [{'pmid': '15285979', 'type': 'BACKGROUND', 'citation': 'Aerni A, Traber R, Hock C, Roozendaal B, Schelling G, Papassotiropoulos A, Nitsch RM, Schnyder U, de Quervain DJ. Low-dose cortisol for symptoms of posttraumatic stress disorder. Am J Psychiatry. 2004 Aug;161(8):1488-90. doi: 10.1176/appi.ajp.161.8.1488.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this prospective, double-blind, placebo-controlled, cross-over study is to determine the therapeutic efficacy of low-dose cortisol for symptoms of chronic posttraumatic stress disorder.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Female and male patients with chronic PTSD due to adult trauma; PTSD is diagnosed according to the DSM-IV, as measured with the CAPS\n* Age between 18 and 60\n\nExclusion Criteria:\n\n* History of disease states representing contraindications to glucocorticoid therapy (tuberculosis, gastritis, gastric- and duodenal ulcers, Cushing's disease, osteoporosis, hypertension, pregnancy (to exclude with a pregnancy test) and lactation, glaucoma, diabetes mellitus, thrombophilia, acute or chronic infections, hyperthyroidism, cirrhosis)\n* Severe or chronic somatic diseases\n* Topic glucocorticoid therapy (for large skin parts)\n* Inhaled glucocorticoids\n* Current psychotic, bipolar, substance-related, or severe personality disorder\n* Current severe depressive disorder\n* Severe cognitive impairment or a history of organic mental disorder\n* Evidence of PTSD or depression immediately prior to the index trauma\n* Prominent current suicidal or homicidal ideation\n* Asylum seeking status\n* Body weight \\>20% above or below normal range\n* Changes in psychopharmacologic or psychotherapeutic management less than 8 weeks before start of the study"}, 'identificationModule': {'nctId': 'NCT00362661', 'briefTitle': 'Low-dose Cortisol in Chronic Posttraumatic Stress Disorder', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Low-dose Cortisol in Chronic Posttraumatic Stress Disorder', 'orgStudyIdInfo': {'id': 'PTSD-06'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Cortisol', 'type': 'DRUG', 'otherNames': ['Cortisol (10 mg), Galepharm, Küsnacht, Switzerland'], 'description': 'Cortisol 10 mg/d for 3 months'}]}, 'contactsLocationsModule': {'locations': [{'zip': '8091', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'Department of Psychiatry, University Hospital Zurich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Dominique de Quervain, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Division of Psychiatry Research, University of Zurich, Lenggstr. 31, 8032 Zurich, Switzerland'}, {'name': 'Ulrich Schnyder, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Psychiatry, University Hospital Zurich, Culmannstrasse 8, 8091 Zürich, Switzerland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dominique de Quervain, Prof. MD', 'oldOrganization': 'University of Zurich'}}}}