Ignite Creation Date:
2024-05-05 @ 5:06 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00382291
Status:
COMPLETED
Last Update Posted:
2013-03-12
First Post:
2006-09-28
Brief Title:
Effectiveness of Sertraline and Cognitive Behavioral Therapy in Treating Pediatric Obsessive-Compulsive Disorder
Sponsor:
University of Florida
Organization:
University of Florida
Study Overview
Official Title:
SSRI-Induced Activation Syndrome in Pediatric Obsessive Compulsive Disorder
Status:
COMPLETED
Status Verified Date:
2012-12
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:
This study measures the occurrence of certain side effects linked to antidepressant use and evaluates the effectiveness of the medication sertraline plus cognitive behavioral therapy to treat people with obsessive-compulsive disorder
Detailed Description:
Obsessive-compulsive disorder OCD is an anxiety disorder that is associated with recurring repetitive behaviors and persistent unwanted thoughts People with OCD often carry out ritual-like behaviors such as counting cleaning or washing their hands in order to momentarily ease their anxiety A current treatment for people with OCD is the class of antidepressants called selective serotonin reuptake inhibitors SSRIs A recent re-analysis of clinical trials on children with psychiatric conditions found that the risk of suicidal thoughts and behavior when on SSRI-antidepressants was considerably higher than when on placebo The data also revealed that antidepressant-associated suicidal behavior was not limited to children with depression but also affected children with OCD and other anxiety disorders Although the process responsible for increased suicidality is unknown it may be initiated by a set of symptoms collectively called SSRI induced activation syndrome which is thought to be common particularly in children and teens However there is a lack of knowledge on this syndrome including its role in suicidal behavior and how it can be prevented This study will evaluate a new behavioral test to measure certain side effects linked to antidepressant use This study will also evaluate the effectiveness of the SSRI sertraline plus cognitive behavioral therapy CBT to treat people with OCD
Potential participants will undergo an initial screening visit that will include an interview on psychological symptoms associated with OCD and possible family history of OCD Eligible participants will then undergo a physical exam blood draw DNA sampling and pregnancy test if applicable Participants will be randomly assigned to receive either sertraline or placebo daily for 18 weeks At weekly study visits participants will receive their study drug complete questionnaires about symptoms of OCD and undergo vital sign measurements At specified visits participants will also perform a task Stop Signal Task on a computerized assessment device to measure attention and impulse control and may have blood drawn For the first 4 weeks participants will wear a wristwatch-like device actigraph to monitor sleep patterns During the first three visits participants will receive supportive psychotherapy At Visit 4 participants will begin receiving 60-minute CBT sessions which will continue until the final visit The final visit will include a second physical exam questionnaires and blood testing
Potential participants will undergo an initial screening visit that will include an interview on psychological symptoms associated with OCD and possible family history of OCD Eligible participants will then undergo a physical exam blood draw DNA sampling and pregnancy test if applicable Participants will be randomly assigned to receive either sertraline or placebo daily for 18 weeks At weekly study visits participants will receive their study drug complete questionnaires about symptoms of OCD and undergo vital sign measurements At specified visits participants will also perform a task Stop Signal Task on a computerized assessment device to measure attention and impulse control and may have blood drawn For the first 4 weeks participants will wear a wristwatch-like device actigraph to monitor sleep patterns During the first three visits participants will receive supportive psychotherapy At Visit 4 participants will begin receiving 60-minute CBT sessions which will continue until the final visit The final visit will include a second physical exam questionnaires and blood testing
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 |
|---|---|---|---|
| DSIR 84-CTM | US NIH GrantContract | None | httpsreporternihgovquickSearchR01MH078594 |
| R01MH078594 | NIH | None | None |