Treatment of Obsessive Compulsive Disorder in Children
Condition: Obsessive-Compulsive Disorder
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will determine whether cognitive behavioral therapy delivered by either
      psychologists or psychiatrists can improve the effectiveness of serotonin reuptake inhibitor
      treatment in children with obsessive compulsive disorder.
    

Detailed description: 
      The vast majority of children with obsessive compulsive disorder (OCD) are given serotonin
      reuptake inhibitor (SRI) drugs as initial treatment. However, recommended doses of these
      medications leave many children with clinically significant residual symptoms. Health care
      experts typically recommend augmenting SRI treatment with cognitive behavioral therapy (CBT),
      yet this recommendation is seldom followed. This study will contrast two CBT augmentation
      strategies to continued medication management alone: CBT administered by a psychologist and
      instructional CBT (I-CBT)administered by a psychiatrist in the context of ongoing medication
      management.

      All patients in the trial will be eligible to receive a full course of CBT by study end.
      Participants in this study will be randomly assigned to receive CBT, I-CBT or continued
      medication management. All participants will continue their SRI treatment for 12 weeks. After
      the 12-week treatment period, participants who received I-CBT or medication management alone
      and who remain symptomatic will be given CBT as will participants who are asymptomatic but
      relapse within 6 months after treatment. Assessments will be conducted at Weeks 0, 4, 8, and
      12. Follow-up assessments will be conducted at 3 and 6 months post-treatment.
    

Intervention name(s): Serotonin reuptake inhibitors management; Cognitive behavioral therapy by a psychologist; Instructional cognitive behavioral therapy by a psychiatrist
Intervention type(s): Drug; Behavioral; Behavioral
Intervention description(s): Participants are maintained on their optimized dose of SRI for OCD symptoms (see "Other Names" section for specific drugs and dosage ranges). If the participant has been treated with an SRI for at least 9 weeks AND has been at a stable dose for the past 3 weeks (e.g., the dose response curve is flat indicating no further improvement in OCD symptoms) OR the participant did not tolerate a dose increase to the next higher dose OR the participant has been at the maximum allowable dose for 3 weeks, then the participant is considered optimized and will be maintained on that dose. During trial, all participants will be maintained on their SRI dose during acute treatment at a constant dose unless side effects warrant downward adjustment of the SRI.; CBT consists of 14 visits over 12 weeks involving: (1) psychoeducation, (2), cognitive training, (3) mapping OCD, and (4) exposure and ritual prevention (EX/RP). The intervention was adapted from March and Mulle (1998) treatment protocol for pediatric OCD.; The psychiatrist who manages medication will also provide instructions in the CBT procedures that have been found to help reduce OCD symptoms, namely EX/RP. MM+I-CBT was constructed as a single-doctor "best practice" treatment with three primary goals: (1) inclusion of the main psychoeducational and EX/RP components of the full CBT protocol; (2) feasibility of training psychiatrists to perform the CBT component of MM+I-CBT; (3) integration with protocol medication management visits; and (4) feasibility of implementation with the constraints of a busy practice oriented primarily toward pharmacotherapy.
Other intervention name(s): Drug Name with Minimum-Maximum Dosage; Citalopram (Celexa)10-60;; Escitalopram (Lexapro)5-30;; Fluoxetine (Prozac) 10-60;; Fluvoxamine (Luvox)25-300;; Paroxetine (Paxil)10-50;; Paroxetine-CR (Paxil)10-50;; Clomipramine (Anafranil)25-200;; Sertraline (Zoloft) 25-200;; Venlafaxine (Effexor)25-225;; Venlafaxine XR (Effexor)37.5-225;
Intervention MeSH terms: Fluvoxamine; Citalopram; Fluoxetine; Paroxetine; Venlafaxine Hydrochloride; Sertraline; Clomipramine; Escitalopram; Selective Serotonin Reuptake Inhibitors; Serotonin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Child; Adolescent