Effectiveness of Sertraline and Cognitive Behavioral Therapy in Treating Pediatric Obsessive-Compulsive Disorder
Condition: Obsessive-Compulsive Disorder
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Regular Titration; Placebo; Slow Titration
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Sertraline will be administered in standard dosing. Treatment with sertraline will last 18 weeks.; The placebo will be administered in the same manner as sertraline. Treatment with placebo will last 18 weeks.; Sertraline will be administered in slow titration. Treatment with sertraline will last 18 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: OCD; Antidepressive Agents, Second-Generation; Placebos; Cognitive Behavior Therapy; Child Psychiatry; Activation Syndrome; Psychometrics