Developing Adaptive Treatment Strategies for Children and Adolescents With Obsessive-compulsive Disorder.
Condition: Obsessive-Compulsive Disorder
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Interventional

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.
    

Intervention name(s): fluoxetine; Group cognitive-behavioral therapy
Intervention type(s): Drug; Behavioral
Intervention description(s): 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
Intervention MeSH terms: Fluoxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Developmental Psychiatry; Sequential Randomized Clinical Trial; Obsessive-Compulsive Disorder D009771