Obsessive Compulsive Disorder
Conditions
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.
Interventions
DRUGLuvox CR
In light of the Luvox-CR dosing procedure of Hollander et al (2003) (50 mg increments weekly) and the available dose capsules of Luvox-CR (100 mg and 150 mg), the Luvox-CR dose will be increased over the first 6 weeks of treatment as tolerated in 50 mg to 100-mg increments every week, as tolerated and clinically indicated, to a bedtime dose between 100 and 300 mg/day. The dose will then be held constant for the duration of the study
BEHAVIORALBehavioral Therapy
The web-based CBT (CT STEPS) includes an introductory session explaining the treatment, with videotapes of OCD patients who used an earlier version, along with 9 subsequent treatment modules. The CBT will include weekly email feedback from a psychologist in response to questions asked about the CBT by the subjects assigned to this treatment arm.
Sponsors
Rogers Center for Research & Training, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. |
Countries
United States
Contacts
Primary ContactAmy Perkins, BA
Outcome results
None listed