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

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ClinicalTrials.gov Identifier: NCT01148316
Recruitment Status : Completed
First Posted : June 22, 2010
Last Update Posted : October 24, 2014
Sponsor:
Collaborator:
University of Pernambuco
Information provided by (Responsible Party):
Roseli Shavitt, University of Sao Paulo

Tracking Information
First Submitted Date  ICMJE June 2, 2010
First Posted Date  ICMJE June 22, 2010
Last Update Posted Date October 24, 2014
Study Start Date  ICMJE August 2010
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 21, 2010)
  • Treatment response status at week 28 [ Time Frame: Yale-Brown Obsessive-Compulsive Scale scores 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.
  • Treatment response status at week 14 [ Time Frame: Yale-Brown Obsessive Compulsive Scale Score 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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 21, 2010)
Predictors of treatment response at week 28 [ Time Frame: KID-SADS, Family Accomodation Scale, Dimensional Yael-Brown Obsessive-Compulsive Scale ]
Socio-demographical and clinical factors, such as gender, age at onset of the disorder, duration of illness, obsessive-compulsive symptom dimensions, psychiatric comorbidities and family accomodation, will be analyzed in relation to the response to the distinct sequential treatments.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Developing Adaptive Treatment Strategies for Children and Adolescents With Obsessive-compulsive Disorder.
Official Title  ICMJE Adaptive Treatment Strategies for Children and Adolescents With Psychiatric Disorders in the Context of Public Health: "Medicine in Practice"
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Obsessive-Compulsive Disorder
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: 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
    Intervention: Drug: fluoxetine
  • Active Comparator: 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
    Intervention: Behavioral: Group cognitive-behavioral therapy
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 23, 2014)
144
Original Estimated Enrollment  ICMJE
 (submitted: June 21, 2010)
240
Actual Study Completion Date  ICMJE December 2013
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 7 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01148316
Other Study ID Numbers  ICMJE IPq-HCFMUSP - 259
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Roseli Shavitt, University of Sao Paulo
Study Sponsor  ICMJE Roseli Shavitt
Collaborators  ICMJE University of Pernambuco
Investigators  ICMJE
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
PRS Account University of Sao Paulo
Verification Date October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP