Status:
UNKNOWN
Cost-Effectiveness of Adding Web-Based Cognitive-Behavioral Therapy (CBT) to Luvox CR for Obsessive Compulsive Disorder (OCD)
Lead Sponsor:
Rogers Center for Research & Training, Inc.
Conditions:
Obsessive Compulsive Disorder
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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...
Detailed Description
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 s...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2009
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00743834
Start Date
September 1 2008
End Date
December 1 2009
Last Update
September 4 2008
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The Rogers Center for Research & Training, Inc.
Milwaukee, Wisconsin, United States, 53227-1133