Status:
COMPLETED
Effectiveness of Sertraline and Cognitive Behavioral Therapy in Treating Pediatric Obsessive-Compulsive Disorder
Lead Sponsor:
University of Florida
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Obsessive-Compulsive Disorder
Eligibility:
All Genders
7-17 years
Phase:
PHASE4
Brief 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 w...
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 behavior...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT00382291
Start Date
February 1 2009
End Date
February 1 2011
Last Update
March 12 2013
Active Locations (2)
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1
University of Florida
Gainesville, Florida, United States, 32611
2
University of South Florida
Tampa, Florida, United States, 33701