Obsessive-Compulsive Disorder Clinical Trial
Official title:
SSRI-Induced Activation Syndrome in Pediatric Obsessive Compulsive Disorder
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.
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.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic
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