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

Primary Purpose

Obsessive Compulsive Disorder

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Luvox CR
Behavioral Therapy
Sponsored by
Rogers Center for Research & Training, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obsessive Compulsive Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • The Rogers Center for Research & Training, Inc.

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

A

Arm Description

Effectiveness of Luvox CR plus Web-based CBT for OCD

Outcomes

Primary Outcome Measures

The primary outcome measure (Y-BOCS score) will be obtained by clinician rating

Secondary Outcome Measures

Full Information

First Posted
August 28, 2008
Last Updated
September 3, 2008
Sponsor
Rogers Center for Research & Training, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00743834
Brief Title
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

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Unknown status
Study Start Date
September 2008 (undefined)
Primary Completion Date
August 2009 (Anticipated)
Study Completion Date
December 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Rogers Center for Research & Training, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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): 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive Compulsive Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Other
Arm Description
Effectiveness of Luvox CR plus Web-based CBT for OCD
Intervention Type
Drug
Intervention Name(s)
Luvox CR
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amy Perkins, BA
Phone
414-328-3702
Email
aperkins@rogershospital.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John H Greist, MD
Organizational Affiliation
The Rogers Center for Research & Training, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Rogers Center for Research & Training, Inc.
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53227-1133
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amy Perkins, BA
Phone
414-328-3702
Email
aperkins@rogershospital.org
First Name & Middle Initial & Last Name & Degree
Alex Bruss, BS
Phone
414-328-3710
Email
abruss@rogershospital.org
First Name & Middle Initial & Last Name & Degree
John H Greist, MD

12. IPD Sharing Statement

Learn more about this trial

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

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