Obsessive-Compulsive Disorder | Developing Adaptive Treatment Strategies for Children and Adolescents With Obsessive-compulsive Disorder.
Obsessive-Compulsive Disorder research study
What is the primary objective of this study?
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.
Who is eligible to participate?
Inclusion Criteria: - diagnosis of obsessive-compulsive disorder according to DSM-IV as major problem - 7 to 17 years - who agree to participate in the research - who have parental permission or legal guardian to participate in the research - that do not have physical or cognitive impairments that prevent the participation of research - YBOCS ≥ 16 for obsession and compulsion or ≥ 10 for only obsession or compulsion only - Be above the tenth percentile of weight corresponding to age - IQ greater than 80 - assessed using the Raven (the screening, if necessary) Exclusion Criteria: - Inability to study evaluated adherence to the beginning. - ANY medical or neurological condition that determines contraindication to any of the treatments or that may influence the evaluation protocol - pregnancy (women of childbearing age should use contraception) - Suicidal ideation (with intent) CURRENT
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:fluoxetinedrops 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 therapyweekly, 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
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Fluoxetinedrops or capsules, 10 to 80mg/Day for 14 weeks (first treatment) and as add-on to group CBT non-responders for additional 14 weeks
Group cognitive-behavioral therapyweekly, 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
Start Date: August 2010
Completed Date: December 2013
Primary Outcome: Treatment response status at week 28
Secondary Outcome: Predictors of treatment response at week 28
Study sponsors, principal investigator, and references
Principal Investigator: Euripedes Miguel, MD, PhD
Lead Sponsor: Roseli Shavitt
Collaborator: University of Pernambuco