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Phase 3 Completed N=124 Randomized Single-blind Treatment

Treatment of Obsessive Compulsive Disorder in Children

Source: ClinicalTrials.gov NCT00074815 ↗
Enrolled (actual)
124
Serious AEs
1.6%
Results posted
Feb 2013
Primary outcomePrimary: Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) — 0.69; 0.34; 0.30 Proportion of Participants with RESPONSE

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.

Outcome Measures

OutcomeResultp-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)

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
View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.

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