Developing Adaptive Treatment Strategies for Children and Adolescents With Obsessive-compulsive Disorder.
Status:
Completed
Trial end date:
2013-12-01
Target enrollment:
Participant gender:
Summary
Obsessive-compulsive disorder affects approximately 2% of the population, frequently has its
onset during childhood or adolescence and is potentially incapacitating. If not properly
treated, this disorder tends to follow a chronic course. Pharmacotherapy with clomipramine
and selective serotonin reuptake inhibitors (SSRIs), such as fluvoxamine, fluoxetine and
sertraline, has been approved for pediatric OCD. However, up to 30% of patients may not
benefit from these treatments, and the presence of residual symptoms is frequent among
treatment responders. Cognitive-behavioral therapy (CBT) is also recognized as first line
treatment for pediatric OCD, either administered in individual or group format. There is
evidence suggesting equivalent efficacy for SSRIs and CBT in pediatric OCD, but there is no
data on adaptive treatment strategies regarding such treatments on the long term outcome of
OCD patients. The aim of this study is to verify, in a randomized design, if there is an
optimal sequential treatment strategy for pediatric OCD, adopting the two most studied
treatments for this disorder: an SSRI and group CBT (GCBT). The investigators hypotheses are:
(1) both types of treatment will present similar efficacy in the short term (14 weeks); (2)
for non-responders to the first type of treatment (fluoxetine up to 80mg/day or GCBT for 14
weeks), combined treatment (fluoxetine + GCBT for another 14 weeks) will be more effective
than switching treatment modality (from fluoxetine to GCBT or from GCBT to fluoxetine for
additional 14 weeks) after additional 14 weeks.