Effectiveness of Sertraline and Cognitive Behavioral Therapy in Treating Pediatric 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 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.

This double-blind study will be divided into two phases. Phase 1 will involve the
development and evaluation of a new behavioral test to measure antidepressant side effects.
Participants will attend a 2-hour screening interview during which they will be asked to
describe any side effects experienced from antidepressant medications and to rate how
problematic these side effects are for them. Participants will be contacted by phone 1 week
later to answer questions repeated from the interview. Participation in Phase 1 will last
about 10 days.

Phase 2 will comprise the medication treatment portion of the study. 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 of Phase 2, 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.