Cost-Effectiveness of Adding Web-Based Cognitive-Behavioral Therapy (CBT) to Luvox CR for Obsessive Compulsive Disorder (OCD)

Status unconfirmed · Phase 4

Conditions studied: Obsessive Compulsive Disorder

In brief

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.

Key facts

Study ID

NCT00743834

Run by

Rogers Center for Research & Training, Inc.

People needed

50

Starts

2008-09-01

Expected to finish

2009-12-01

Last updated by the study team

2008-09-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• The Rogers Center for Research & Training, Inc. — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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