Phase 3
N=124
Treatment of Obsessive Compulsive Disorder in Children
Obsessive-Compulsive Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00074815 ↗Enrolled (actual)
124
Serious AEs
1.6%
Results posted
Feb 2013
Primary outcome: Primary: Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) — 0.69; 0.34; 0.30 Proportion of Participants with RESPONSE
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Serotonin reuptake inhibitors management (Drug); Cognitive behavioral therapy by a psychologist (Behavioral); Instructional cognitive behavioral therapy by a psychiatrist (Behavioral)
- Age
- Pediatric · 7+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Nov 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) |
0.69; 0.34; 0.30 | — |
| SECONDARY Child Obsessive -Compulsive Impact Scale (COIS) |
— | — |
| SECONDARY Child Depression Inventory |
— | — |
| SECONDARY Pediatric Adverse Event Rating Scale (PAERS) |
— | — |
Summary
This study will determine whether cognitive behavioral therapy delivered by either psychologists or psychiatrists can improve the effectiveness of serotonin reuptake inhibitor treatment in children with obsessive compulsive disorder.
Eligibility Criteria
Inclusion Criteria
- DSM-IV Diagnosis of obsessive compulsive disorder
- CYBOCS total score greater than 16
Exclusion Criteria
- Other primary or co-primary psychiatric disorder
- Pervasive developmental disorder or disorders, including Asperger's Syndrome
- Thought disorder
- Prior failed trial of cognitive-behavioral therapy
- Has pediatric autoimmune neuropsychiatric disorders associated with streptococcus (PANDAS) or maintenance antibiotic for obsessive-compulsive disorder
- Mental retardation
- Pregnancy
Data sourced from ClinicalTrials.gov (NCT00074815). 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.