Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-26 @ 6:10 AM
Study NCT ID:
NCT00743834
Status:
UNKNOWN
Last Update Posted:
2008-09-04
First Post:
2008-08-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cost-Effectiveness of Adding Web-Based Cognitive-Behavioral Therapy (CBT) to Luvox CR for Obsessive Compulsive Disorder (OCD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009771', 'term': 'Obsessive-Compulsive Disorder'}], 'ancestors': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016666', 'term': 'Fluvoxamine'}, {'id': 'D001521', 'term': 'Behavior Therapy'}], 'ancestors': [{'id': 'D010091', 'term': 'Oximes'}, {'id': 'D006898', 'term': 'Hydroxylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-09', 'completionDateStruct': {'date': '2009-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2008-09-03', 'studyFirstSubmitDate': '2008-08-28', 'studyFirstSubmitQcDate': '2008-08-28', 'lastUpdatePostDateStruct': {'date': '2008-09-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-08-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary outcome measure (Y-BOCS score) will be obtained by clinician rating', 'timeFrame': 'screening, baseline, and end of weeks 4, 8, 12, 16, 20 and 24.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Obsessive Compulsive Disorder']}, 'descriptionModule': {'briefSummary': 'This study will test the hypotheses that: 1. 12 weeks of Luvox-CR plus web-based Cognitive-Behavioral Therapy (CBT) \\[CT-STEPS\\] will produce greater symptom relief of OCD than treatment with Luvox-CR alone; and, 2. subjects receiving 12 weeks of CT-STEPS added to Luvox-CR treatment after 12-weeks of Luvox-CR monotherapy will experience greater OCD symptom relief (from weeks 12-24) than those continuing Luvox-CR treatment and having access to CT-STEPS from week one. 3. subjects who begin CT-STEPS at week 12 will be more likely to complete it than those who begin CT-STEPS at baseline.', 'detailedDescription': 'Primary Endpoint(s): Change in Y-BOCS score from baseline to endpoint at weeks 12 and 24; and, number (and percent) "responders" at weeks 12 and 24, defined as subjects with a 35% decrease in Y-BOCS score at endpoint and a Clinical Global Impressions score of 1 or 2 (very much or much improved).\n\nSecondary Endpoint(s):\n\n1. change in scores on the Work and Social Adjustment Scale, a quality of life measure\n2. change in scores on the Work Productivity and Activity Impairment\n\n Questionnaire:\n\n Specific Health Problem scale; in particular, we will analyze change in work hours/week lost because of OCD, and change in effect of OCD on work productivity (0-10 scale).\n3. dollar cost per responder\n4. dollar cost per total number of patients needed to produce one additional responder in the Luvox-CR plus web-based CBT group over the number produced by Luvox-CR alone, i.e., dollar cost per number needed to treat\n5. dollar cost per 5% decrease in Y-BOCS score at weeks 12 and 24 in the two treatment groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Men and women aged 18 years, with OCD of at least 1 year's duration, meeting DSM-IV diagnostic criteria, and having a baseline Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) score of 18.\n\nExclusion Criteria:\n\n* Pregnant or nursing women or women of childbearing age not using an effective contraceptive method\n* Organic mental disorder\n* Bipolar disorder\n* Psychotic disorder\n* History of substance abuse or dependence within 3 years of evaluation for study\n* Major depression with suicidal risk\n* Major depression dominating the clinical picture\n* Panic disorder\n* Personality disorder severe enough to interfere with cooperation with study procedures\n* Need for antipsychotic medication\n* Depot neuroleptic drug within 6 months\n* Fluoxetine within 5 weeks\n* An MAOI within 2 weeks, any nightly sedative, or taking a medication that may interact with fluvoxamine\n* Serious or unstable medical condition (hematological, endocrine, cardiovascular, renal or gastrointestinal), a history of malignancy (other than excised basal cell carcinoma), history of brain disease, including more than one childhood febrile convulsion and all forms of epilepsy; or, are receiving behavior therapy for OCD.\n* Subjects who qualify for the study while taking an SSRI must have been taking their current dose or a higher dose for at least 12 weeks prior to study baseline.\n* Subjects who qualify for the study while taking fluvoxamine must be taking no more than 150 mg/day and never had a trial at a higher dose, must be believed by the investigator to be able to tolerate an increase to 250 mg/day starting at baseline, and must have been taking their pre-study dose or a higher dose (up to 150 mg/day) for at least 12 weeks prior to study baseline."}, 'identificationModule': {'nctId': 'NCT00743834', 'briefTitle': 'Cost-Effectiveness of Adding Web-Based Cognitive-Behavioral Therapy (CBT) to Luvox CR for Obsessive Compulsive Disorder (OCD)', 'organization': {'class': 'OTHER', 'fullName': 'Rogers Center for Research & Training, Inc.'}, 'officialTitle': 'Cost-Effectiveness of Adding Web-Based CBT to Luvox CR for OCD', 'orgStudyIdInfo': {'id': 'JIIT-07-LCR001a'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'A', 'description': 'Effectiveness of Luvox CR plus Web-based CBT for OCD', 'interventionNames': ['Drug: Luvox CR', 'Behavioral: Behavioral Therapy']}], 'interventions': [{'name': 'Luvox CR', 'type': 'DRUG', 'description': 'In light of the Luvox-CR dosing procedure of Hollander et al (2003) (50 mg increments weekly) and the available dose capsules of Luvox-CR (100 mg and 150 mg), the Luvox-CR dose will be increased over the first 6 weeks of treatment as tolerated in 50 mg to 100-mg increments every week, as tolerated and clinically indicated, to a bedtime dose between 100 and 300 mg/day. The dose will then be held constant for the duration of the study', 'armGroupLabels': ['A']}, {'name': 'Behavioral Therapy', 'type': 'BEHAVIORAL', 'description': 'The web-based CBT (CT STEPS) includes an introductory session explaining the treatment, with videotapes of OCD patients who used an earlier version, along with 9 subsequent treatment modules. The CBT will include weekly email feedback from a psychologist in response to questions asked about the CBT by the subjects assigned to this treatment arm.', 'armGroupLabels': ['A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53227-1133', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'contacts': [{'name': 'Amy Perkins, BA', 'role': 'CONTACT', 'email': 'aperkins@rogershospital.org', 'phone': '414-328-3702'}, {'name': 'Alex Bruss, BS', 'role': 'CONTACT', 'email': 'abruss@rogershospital.org', 'phone': '414-328-3710'}, {'name': 'John H Greist, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Rogers Center for Research & Training, Inc.', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'centralContacts': [{'name': 'Amy Perkins, BA', 'role': 'CONTACT', 'email': 'aperkins@rogershospital.org', 'phone': '414-328-3702'}], 'overallOfficials': [{'name': 'John H Greist, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Rogers Center for Research & Training, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rogers Center for Research & Training, Inc.', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'John H Greist, MD', 'oldOrganization': 'Rogers Center for Research & Training, Inc.'}}}}