Obsessive Compulsive Disorder Clinical Trial
Official title:
Cost-Effectiveness of Adding Web-Based CBT to Luvox CR for OCD
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.
Status | Not yet recruiting |
Enrollment | 50 |
Est. completion date | December 2009 |
Est. primary completion date | August 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - Pregnant or nursing women or women of childbearing age not using an effective contraceptive method - Organic mental disorder - Bipolar disorder - Psychotic disorder - History of substance abuse or dependence within 3 years of evaluation for study - Major depression with suicidal risk - Major depression dominating the clinical picture - Panic disorder - Personality disorder severe enough to interfere with cooperation with study procedures - Need for antipsychotic medication - Depot neuroleptic drug within 6 months - Fluoxetine within 5 weeks - An MAOI within 2 weeks, any nightly sedative, or taking a medication that may interact with fluvoxamine - 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. - 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. - 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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | The Rogers Center for Research & Training, Inc. | Milwaukee | Wisconsin |
Lead Sponsor | Collaborator |
---|---|
Rogers Center for Research & Training, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary outcome measure (Y-BOCS score) will be obtained by clinician rating | screening, baseline, and end of weeks 4, 8, 12, 16, 20 and 24. | No |
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