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

Sponsored by:	Rogers Center for Research & Training, Inc.
Information provided by:	Rogers Center for Research & Training, Inc.
ClinicalTrials.gov Identifier:	NCT00743834

Purpose

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.

Condition	Intervention	Phase
Obsessive Compulsive Disorder	Drug: Luvox CR Behavioral: Behavioral Therapy	Phase IV

MedlinePlus related topics: Obsessive-Compulsive Disorder

Drug Information available for: Fluvoxamine maleate Fluvoxamine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Active Control, Factorial Assignment, Efficacy Study
Official Title:	Cost-Effectiveness of Adding Web-Based CBT to Luvox CR for OCD

Further study details as provided by Rogers Center for Research & Training, Inc.:

Primary Outcome Measures:

The primary outcome measure (Y-BOCS score) will be obtained by clinician rating [ Time Frame: screening, baseline, and end of weeks 4, 8, 12, 16, 20 and 24. ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	September 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A Effectiveness of Luvox CR plus Web-based CBT for OCD	Drug: Luvox 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 Behavioral: Behavioral 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.

Arms

Assigned Interventions

A

Effectiveness of Luvox CR plus Web-based CBT for OCD

Drug: Luvox 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

Behavioral: Behavioral 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.

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):

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00743834

Contacts

Contact: Amy Perkins, BA

414-328-3702

aperkins@rogershospital.org

Locations

United States, Wisconsin
The Rogers Center for Research & Training, Inc.
Milwaukee, Wisconsin, United States, 53227-1133

Sponsors and Collaborators

Rogers Center for Research & Training, Inc.

Investigators

Principal Investigator:

John H Greist, MD

The Rogers Center for Research & Training, Inc.

More Information

Responsible Party:	Rogers Center for Research & Training, Inc. ( John H Greist, MD )
Study ID Numbers:	JIIT-07-LCR001a
Study First Received:	August 28, 2008
Last Updated:	September 3, 2008
ClinicalTrials.gov Identifier:	NCT00743834
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Fluvoxamine
Anxiety Disorders
Mental Disorders
Serotonin
Obsessive-Compulsive Disorder

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Disease
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Serotonin Uptake Inhibitors

Pharmacologic Actions
Serotonin Agents
Pathologic Processes
Therapeutic Uses
Anti-Anxiety Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on January 16, 2009