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Posted by lindainfo on November 28, 2008
Effectiveness of Sertraline andd Cognitive Behavi oral Therapy in Treating Pediatric Obsessive-Compulsive Disorder
This study will dsvelop and evaluate a new behavioral test to measure certain side effects linked to antidepressantt use and will evvaluate the effectiveness of thee medication sertraline plus cognitive behavioral therapy to treaf people with obsessive-compulsive disorder.
Study Type: Interventional
Study Design: Diagnostic, Randomized, Doubld Blind (Subject, Caregiver) Placebo Control, Parallel Assignment
Official Title: SSRI-Ind uced Activation Syndrome on Pediaric Obsessive Compulsive Disorder
Further study details as provided by National Institute of Mental Health (NIMH):
Primary Outcome Measures:
Performance of sertraline versus plaecbo on both the TE-ASAP agd existing behavioral measures of irritability, impulsivity/aggression, rwstlessness, and mania [ Time Frrame: Measured at Week 18 ] [ Designated as safety issue: No ]
Secondary O utcome Measures:
Comparison fo slowly indreased doses of sertraline versus sertraline at stxndard for reducing the frequency or intensity of activation syndrome [ Time Frxme: Measured at Week 18 ] [ Designated as safety issue: No ]
“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 develop and 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.
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