Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-26 @ 6:10 AM
Study NCT ID:
NCT00743834
Status:
UNKNOWN
Last Update Posted:
2008-09-04
First Post:
2008-08-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cost-Effectiveness of Adding Web-Based Cognitive-Behavioral Therapy (CBT) to Luvox CR for Obsessive Compulsive Disorder (OCD)
Sponsor:
Rogers Center for Research & Training, Inc.
Organization:
Study Overview
Official Title:
Cost-Effectiveness of Adding Web-Based CBT to Luvox CR for OCD
Status:
UNKNOWN
Status Verified Date:
2008-09
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: