Ignite Creation Date:
2024-05-06 @ 6:16 PM
Last Modification Date:
2024-10-26 @ 2:45 PM
Study NCT ID:
NCT05609916
Status:
RECRUITING
Last Update Posted:
2024-06-21
First Post:
2022-10-27
Brief Title:
CBT Augmentation to Promote Medication Discontinuation in Pediatric OCD
Sponsor:
Baylor College of Medicine
Organization:
Baylor College of Medicine
Study Overview
Official Title:
CBT Augmentation to Promote Medication Discontinuation in Pediatric OCD
Status:
RECRUITING
Status Verified Date:
2024-06
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 examine whether youth with OCD who benefit from CBT augmentation to SRI can discontinue their medication without relapse over 24 weeks
Detailed Description:
Pediatric obsessive-compulsive disorder OCD is a common chronic and severe psychiatric disorder Currently many youth with OCD are treated with medication such as a serotonin reuptake inhibitor SRI however only a subset of them responds to SRI Data show that the addition of cognitive-behavioral therapy CBT to SRI partial responders is effective although extended SRI use with CBT can attenuate combined treatment outcomes This placebo-controlled study will enroll pediatric OCD patients to examine if those who benefit from CBT augmentation can discontinue their SRI successfully without relapse over 24-weeks This study will also bank genomic samples for future analysis when polygenic risk scores for OCD may become available
This study will be conducted in two phases In Phase I all participants will receive a web-based CBT for 12 to 18 weeks At the end of Phase I those who achieve wellness indicated by CY-BOCS 12 and 50 reduction since baseline for 3 consecutive weeks will go on to the next phase In Phase II participants will be randomized into two groups 1 Continued SRI and 2 Discontinuation titration to placebo In this phase all participants will receive web-based CBT maintenance sessions and attend medication visits for 24 weeks At 12 months after the end of Phase II all participants will complete a follow-up assessment
This study will be conducted in two phases In Phase I all participants will receive a web-based CBT for 12 to 18 weeks At the end of Phase I those who achieve wellness indicated by CY-BOCS 12 and 50 reduction since baseline for 3 consecutive weeks will go on to the next phase In Phase II participants will be randomized into two groups 1 Continued SRI and 2 Discontinuation titration to placebo In this phase all participants will receive web-based CBT maintenance sessions and attend medication visits for 24 weeks At 12 months after the end of Phase II all participants will complete a follow-up assessment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None