Developing Adaptive Treatment Strategies for Children and Adolescents With Obsessive-compulsive Disorder.
Information source: University of Sao Paulo
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Obsessive-Compulsive Disorder
Intervention: fluoxetine (Drug); Group cognitive-behavioral therapy (Behavioral)
Phase: N/A
Status: Completed
Sponsored by: Roseli Shavitt Official(s) and/or principal investigator(s): Euripedes Miguel, MD, PhD, Principal Investigator, Affiliation: University of Sao Paulo Roseli G Shavitt, MD, PhD, Study Director, Affiliation: University of Sao Paulo Guilherme V Polanczyk, MD, PhD, Study Chair, Affiliation: University of Sao Paulo
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.
Clinical Details
Official title: Adaptive Treatment Strategies for Children and Adolescents With Psychiatric Disorders in the Context of Public Health: "Medicine in Practice"
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Treatment response status at week 28Treatment response status at week 14
Secondary outcome: Predictors of treatment response at week 28
Detailed description:
This is a 28-week open protocol, composed of two phases of randomized treatments with 14
weeks duration.
Inclusion criteria: DSM-IV diagnosis of OCD; age between 7 and 17 years; willing to
participate in the protocol; parents or legal tutors agreement with their child
participation in the protocol; absence of physical or cognitive impairment that prevent the
participation in the protocol.
We expect to end the protocol with 50 patients in each arm (total = 200). For this reason,
the purpose is to recruit at least 400 patients for the first randomization (R1: fluoxetine
X group CBT). Responders to the initial type of treatment will be maintained in the same
procedure for additional 14 weeks. The second randomization (R2) will address non-responders
to fluoxetine, who will be randomized to switch to group CBT or receive group CBT as add-on
therapy; and non-responders to group CBT, who will be randomized to switch to fluoxetine or
receive fluoxetine as add-on therapy.
Fluoxetine will be administered in drops or capsules, in doses ranging from 10 to 80mg/day.
Group CBT will be delivered weekly, in 2-hour sessions, in groups of 6 to 8 participants.
At the end of each treatment (weeks 14 and 28), treatment response will be assessed by blind
raters, through the YBOCS and CGI-global improvement subscale. Response will be defined as
at least 35% reduction in baseline YBOCS scores and a CGI score of 1 or 2.
Efficacy of treatments at the end of R1 will be compared and the efficacy of the different
sequences of treatments at the end of R2 (adaptive treatment strategies) will be compared by
means of an intention-to-treat analysis.
Eligibility
Minimum age: 7 Years.
Maximum age: 17 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Institue of Psychiatry - Hospital of Clinics - University of São Paulo, São Paulo 05403-000, Brazil
Additional Information
Starting date: August 2010
Last updated: October 23, 2014
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