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
Intervention: Regular Titration; Placebo; Slow Titration
Intervention description: 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.
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 56.0
Sex: All
Minimum age: 7 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: OCD; Antidepressive Agents, Second-Generation; Placebos; Cognitive Behavior Therapy; Child Psychiatry; Activation Syndrome; Psychometrics

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Principal diagnosis of OCD with at least a 6-month duration, as determined by
             structured clinical interview (schedule for affective disorders and schizophrenia for
             school-age children)

          -  As long as OCD is the principal diagnosis, co-morbid depression, attention deficit
             hyperactivity disorder, tic disorder, or another anxiety disorder is allowable

          -  Diagnosis of trichotillomania or body dysmorphic disorder provided OCD symptoms are
             the predominant presenting features

          -  Meets clinical criteria for Pediatric Autoimmune Neuropsychiatric Disorders Associated
             with Streptococcal Infections (PANDAS) (e.g., abrupt onset and dramatic fluctuations
             in symptoms)

        Exclusion Criteria:

          -  Prior adequate trial of sertraline

          -  Allergy to sertraline

          -  History of rheumatic fever or serious autoimmune disorder

          -  Diagnosis of bipolar disorder, autism, schizophrenia, mental retardation, or chronic
             degenerative neurological disease

          -  Current anorexia nervosa with symptoms of body image distortion (symptoms of anorexia
             secondary to obsessions [e.g., contamination] are permitted)

          -  Unable to safely swallow study medication after pill swallowing education

          -  Unwillingness of children's parents to commit to accompanying their child for multiple
             study visits and to be responsible for medication compliance

          -  Suicidal intent (suicidal ideation will not be an automatic exclusion; however, risk
             will be gauged carefully and the participant must contract for safety)

          -  Suicide attempt in the 12 months prior to study entry

          -  Pregnancy

          -  Taking monoamine oxidase inhibitors (MAOIs) within 4 weeks of study entry or
             fluoxetine within 5 weeks of study entry

          -  Taking other psychotropic medications other than sedative or hypnotics for insomnia

          -  Substance abuse or dependence within 6 months prior to study entry