Developing Adaptive Treatment Strategies for Children and Adolescents With Obsessive-compulsive Disorder.
SMART
Adaptive Treatment Strategies for Children and Adolescents With Psychiatric Disorders in the Context of Public Health: "Medicine in Practice"
1 other identifier
interventional
144
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2010
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 2, 2010
CompletedFirst Posted
Study publicly available on registry
June 22, 2010
CompletedStudy Start
First participant enrolled
August 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedOctober 24, 2014
October 1, 2014
2.8 years
June 2, 2010
October 23, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Treatment response status at week 28
The primary outcome will be the treatment response status, as measured by the variation of Yale-Brown Obsessive-Compulsive Scale,after having received,in a randomized design, different sequential treatments for obsessive-compulsive disorder.
Yale-Brown Obsessive-Compulsive Scale scores at week 28
Treatment response status at week 14
Treatment resposnse to the first treatment assigned, fluoxetine or group cognitive-behavioral therapy, will be assessed at week 14. Non- responders will be randomized to the second treatment: either combination therapy (fluoxetine plus group cognitive-behavioral therapy) or switch to the other first line treatment (non-responders to fluoxetine as the first treatment switch to group cognitive behavioral therapy and non-responders to cognitive behavioral therapy switch to fluoxetine)
Yale-Brown Obsessive Compulsive Scale Score at week 14
Secondary Outcomes (1)
Predictors of treatment response at week 28
KID-SADS, Family Accomodation Scale, Dimensional Yael-Brown Obsessive-Compulsive Scale
Study Arms (2)
Fluoxetine
ACTIVE COMPARATORdrops 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 therapy
ACTIVE COMPARATORweekly, 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
Interventions
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
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
Eligibility Criteria
You may qualify if:
- diagnosis of obsessive-compulsive disorder according to DSM-IV as major problem
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Roseli Shavittlead
- University of Pernambucocollaborator
Study Sites (1)
Institue of Psychiatry - Hospital of Clinics - University of São Paulo
São Paulo, São Paulo, 05403-000, Brazil
Related Publications (1)
Vattimo EFQ, Barros VB, Requena G, Sato JR, Fatori D, Miguel EC, Shavitt RG, Hoexter MQ, Batistuzzo MC. Caudate volume differences among treatment responders, non-responders and controls in children with obsessive-compulsive disorder. Eur Child Adolesc Psychiatry. 2019 Dec;28(12):1607-1617. doi: 10.1007/s00787-019-01320-w. Epub 2019 Apr 10.
PMID: 30972581DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Euripedes Miguel, MD, PhD
University of Sao Paulo
- STUDY DIRECTOR
Roseli G Shavitt, MD, PhD
University of Sao Paulo
- STUDY CHAIR
Guilherme V Polanczyk, MD, PhD
University of Sao Paulo
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
June 2, 2010
First Posted
June 22, 2010
Study Start
August 1, 2010
Primary Completion
June 1, 2013
Study Completion
December 1, 2013
Last Updated
October 24, 2014
Record last verified: 2014-10