Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000384
Status:
COMPLETED
Last Update Posted:
2016-08-22
First Post:
1999-11-02
Brief Title:
Treatment of Obsessive-Compulsive Disorder OCD in Children
Sponsor:
University of Pennsylvania
Organization:
University of Pennsylvania
Study Overview
Official Title:
Treatment of Pediatric Obsessive-Compulsive Disorder
Status:
COMPLETED
Status Verified Date:
2005-11
Last Known Status:
None
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:
The purpose of this study is to compare 3 treatments for children with OCD medication sertraline SER alone vs OCD-specific therapy Cognitive Behavior Therapy CBT vs medication plus therapy Some patients will receive an inactive placebo PBO instead of medication andor Educational Support ES non-psychological treatment instead of therapy
One in 200 children suffer from OCD but few receive appropriate treatment Both CBT and medication seem to be effective but their effectiveness alone and in combination has not been evaluated
There are 2 phases to this trial In Phase I the child will receive 1 of the following 6 treatments for 12 weeks 1 SER alone 2 pill PBO alone 3 CBT alone 4 SER plus CBT 5 SER plus ES 6 pill PBO plus ES If the child responds to treatment heshe will go on to Phase II in which the treatment will be slowly reduced then stopped discontinued over time to test the treatments durability The child will be evaluated at Weeks 1 4 8 12 Phase I treatment and Weeks 16 20 24 and 28 Phase II discontinuation to see how effective and durable the treatment is in treating your childs OCD
A child may be eligible for this study if heshe
Has obsessive-compulsive disorder OCD and is 8 - 16 years old
One in 200 children suffer from OCD but few receive appropriate treatment Both CBT and medication seem to be effective but their effectiveness alone and in combination has not been evaluated
There are 2 phases to this trial In Phase I the child will receive 1 of the following 6 treatments for 12 weeks 1 SER alone 2 pill PBO alone 3 CBT alone 4 SER plus CBT 5 SER plus ES 6 pill PBO plus ES If the child responds to treatment heshe will go on to Phase II in which the treatment will be slowly reduced then stopped discontinued over time to test the treatments durability The child will be evaluated at Weeks 1 4 8 12 Phase I treatment and Weeks 16 20 24 and 28 Phase II discontinuation to see how effective and durable the treatment is in treating your childs OCD
A child may be eligible for this study if heshe
Has obsessive-compulsive disorder OCD and is 8 - 16 years old
Detailed Description:
To contrast the degree and durability of improvement in pediatric obsessive-compulsive disorder OCD patients will be treated with 1 of 6 conditions 3 active treatments and 3 control treatments sertraline alone SER OCD-specific Cognitive Behavior Therapy CBT both SER and CBT SER plus CBT pill placebo PBO pill PBO plus Educational Support ES and SER plus ES
One in 200 youth suffers from OCD yet relatively few receive appropriate treatment Both CBT and medication appear beneficial in controlled studies however the relative efficacy of CBT and medication alone and in combination COMB is unknown Thus well-designed treatment outcome studies are necessary to improve care for youth with OCD
The experimental design covers 2 phases Phase I is a 2 site x 2 SER or pill PBO x 3 CBT ES or non- psychosocial treatment x 5 repeated measures factorial 12-week comparison of SER CBT COMB and the control conditions In Phase II responders advance to a 16-week discontinuation study to assess treatment durability The primary outcome measure is the Yale-Brown Obsessive-Compulsive Scale Assessments blind to treatment status take place at Week 0 pretreatment Weeks 1 4 8 12 Phase I treatment and Weeks 16 20 24 and 28 Phase II discontinuation Besides addressing comparative efficacy and durability of the specified treatments the investigators also examine time-action effects differential effects on specific aspects of OCD including functional impairment and predictors of response to treatment
One in 200 youth suffers from OCD yet relatively few receive appropriate treatment Both CBT and medication appear beneficial in controlled studies however the relative efficacy of CBT and medication alone and in combination COMB is unknown Thus well-designed treatment outcome studies are necessary to improve care for youth with OCD
The experimental design covers 2 phases Phase I is a 2 site x 2 SER or pill PBO x 3 CBT ES or non- psychosocial treatment x 5 repeated measures factorial 12-week comparison of SER CBT COMB and the control conditions In Phase II responders advance to a 16-week discontinuation study to assess treatment durability The primary outcome measure is the Yale-Brown Obsessive-Compulsive Scale Assessments blind to treatment status take place at Week 0 pretreatment Weeks 1 4 8 12 Phase I treatment and Weeks 16 20 24 and 28 Phase II discontinuation Besides addressing comparative efficacy and durability of the specified treatments the investigators also examine time-action effects differential effects on specific aspects of OCD including functional impairment and predictors of response to treatment
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01MH055126 | NIH | None | None |
| R10MH055121 | NIH | None | None |
| DSIR 84-CTM | US NIH GrantContract | None | httpsreporternihgovquickSearchR10MH055121 |