Effectiveness of Sertraline and Cognitive Behavioral Therapy in Treating Pediatric Obsessive-Compulsive Disorder

Completed · Phase 4 · Has a placebo group

Conditions studied: Obsessive-Compulsive Disorder

In brief

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.

Key facts

Study ID

NCT00382291

Run by

University of Florida

People needed

56

Starts

2009-02-01

Expected to finish

2011-02-01

Last updated by the study team

2013-03-12

Who can join

Age: 7 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• University of Florida — Gainesville, Florida, United States
• University of South Florida — Tampa, Florida, United States

Full record on ClinicalTrials.gov

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