Developing Adaptive Treatment Strategies for Children and Adolescents With Obsessive-compulsive Disorder.

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.

Conditions

• Obsessive-Compulsive Disorder

Interventions

DRUG

fluoxetine

drops or capsules, 10 to 80mg/Day for 14 weeks (first treatment) and as add-on to group CBT non-responders for additional 14 weeks

BEHAVIORAL

Group cognitive-behavioral therapy

weekly, 2 hour sessions with one therapist and one co-therapist for 14 weeks and as add-on to fluoxetine non-responders for additional 14 weeks

Sponsors & Collaborators

• University of Pernambuco

  collaborator OTHER

• Roseli Shavitt

  lead OTHER

Principal Investigators

• Euripedes Miguel, MD, PhD · University of Sao Paulo

• Roseli G Shavitt, MD, PhD · University of Sao Paulo

• Guilherme V Polanczyk, MD, PhD · University of Sao Paulo

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

7 Years

Max Age

17 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2010-08-31

Primary Completion

2013-06-30

Completion

2013-12-31

Countries

• Brazil

Study Locations