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

Rogers Center for Research & Training, Inc.

Status and phase

Unknown

Phase 4

Conditions

Obsessive Compulsive Disorder

Treatments

Behavioral: Behavioral Therapy

Drug: Luvox CR

Study type

Interventional

Funder types

Other

Identifiers

NCT00743834

JIIT-07-LCR001a

Details and patient eligibility

About

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.

Full 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):

change in scores on the Work and Social Adjustment Scale, a quality of life measure
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).
dollar cost per responder
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
dollar cost per 5% decrease in Y-BOCS score at weeks 12 and 24 in the two treatment groups.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.