Phase 4
N=56
Effectiveness of Sertraline and Cognitive Behavioral Therapy in Treating Pediatric Obsessive-Compulsive Disorder
Obsessive-Compulsive Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00382291 ↗Enrolled (actual)
56
Serious AEs
3.6%
Results posted
Mar 2013
Primary outcome: Primary: Clinical Global Impression - Severity of Activation (CGI-SA) — .50; 2.00; 2.00 units on a scale — p=.2106
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Regular Titration (Drug); Placebo (Drug); Slow Titration (Drug)
- Age
- Pediatric · 7+ yrs
- Sex
- All
- Sponsor
- University of Florida
- Primary completion
- Feb 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Global Impression - Severity of Activation (CGI-SA) |
.50; 2.00; 2.00 | .2106 |
| PRIMARY Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) Total Score |
16.28; 16.35; 17.67 | .8831 |
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
Data sourced from ClinicalTrials.gov (NCT00382291). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.