Clinical trial NCT00743834: Cost-Effectiveness of Adding Web-Based Cognitive-Behavioral Therapy (CBT) to Luvox CR for Obsessive Compulsive Disorder (OCD)
Official title: Cost-Effectiveness of Adding Web-Based CBT to Luvox CR for OCD
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Obsessive Compulsive Disorder
Lead sponsor: Rogers Center for Research & Training, Inc.
Sponsor class: OTHER
First posted: 2008-08-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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 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.

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 score at endpoint and a Clinical Global Impressions score of 1 or 2 (very much or much improved).

Secondary Endpoint(s):

1. change in scores on the Work and Social Adjustment Scale, a quality of life measure
2. change in scores on the Work Productivity and Activity Impairment

   Questionnaire:

   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).
3. dollar cost per responder
4. 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
5. dollar cost per 5% decrease in Y-BOCS score at weeks 12 and 24 in the two treatment groups.

Eligibility criteria: 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.

Primary outcomes:
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.
Secondary outcomes:
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: The Rogers Center for Research & Training, Inc.
state: Wisconsin
Study officials:
affiliation: The Rogers Center for Research & Training, Inc.
name: John H Greist, MD
role: PRINCIPAL_INVESTIGATOR
References: