Treatment of Obsessive Compulsive Disorder in Children

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00074815
First received: December 19, 2003
Last updated: July 23, 2014
Last verified: November 2012

December 19, 2003
July 23, 2014
September 2003
November 2009   (final data collection date for primary outcome measure)
Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) [ Time Frame: Measured at baseline and Week 12. ] [ Designated as safety issue: Yes ]

OCD symptom severity was measured using the CY-BOCS, an interviewer-rated instrument that assess obsessions and compulsions separately on time consumed, distress, interference, degree of resistance, and control; it yields separate severity scores for obsessions and for compulsions (0 - 20), and a composite symptom severity score (0 to 40).

Consistent with signal detection analyses examining the optimal criterion for treatment response, a CY-BOCS reduction of 30% or more from baseline to week 12 was used as the criterion for RESPONSE and was the primary dichotomous outcome measure.

Not Provided
Complete list of historical versions of study NCT00074815 on ClinicalTrials.gov Archive Site
  • Child Obsessive -Compulsive Impact Scale (COIS) [ Time Frame: Measured at baseline; Weeks 4, 8, and 12; and Months 3 and 6 of follow-up ] [ Designated as safety issue: No ]
  • Child Depression Inventory [ Time Frame: Measured at baseline; Weeks 4, 8, and 12; and Months 3 and 6 of follow-up ] [ Designated as safety issue: Yes ]
  • Pediatric Adverse Event Rating Scale (PAERS) [ Time Frame: Measured at baseline; Weeks 4, 8, and 12; and Months 3 and 6 of follow-up ] [ Designated as safety issue: Yes ]
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Not Provided
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Treatment of Obsessive Compulsive Disorder in Children
Treatment of Pediatric OCD for SRI Partial Responders

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Obsessive-Compulsive Disorder
  • Drug: Serotonin reuptake inhibitors management
    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.
    Other Names:
    • 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;
  • Behavioral: Cognitive behavioral therapy by a psychologist
    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.
  • Behavioral: Instructional cognitive behavioral therapy by a psychiatrist
    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.
  • Experimental: MedMgmt+CBT
    Participants will receive the following interventions: 1)SRI medication management with a psychiatrist plus, 2) cognitive behavioral therapy with a psychologist.
    Interventions:
    • Drug: Serotonin reuptake inhibitors management
    • Behavioral: Cognitive behavioral therapy by a psychologist
  • Experimental: MedMgmt+I-CBT
    Participants will receive the following interventions 1)SRI medication management plus, 2) instructional cognitive behavioral therapy. Both of these will be implemented by the same psychiatrist.
    Interventions:
    • Drug: Serotonin reuptake inhibitors management
    • Behavioral: Instructional cognitive behavioral therapy by a psychiatrist
  • Active Comparator: MedMgmt Only
    Participants will receive the intervention SRI medication management with a psychiatrist
    Intervention: Drug: Serotonin reuptake inhibitors management
Franklin ME, Sapyta J, Freeman JB, Khanna M, Compton S, Almirall D, Moore P, Choate-Summers M, Garcia A, Edson AL, Foa EB, March JS. Cognitive behavior therapy augmentation of pharmacotherapy in pediatric obsessive-compulsive disorder: the Pediatric OCD Treatment Study II (POTS II) randomized controlled trial. JAMA. 2011 Sep 21;306(11):1224-32. doi: 10.1001/jama.2011.1344. Erratum in: JAMA. 2012 Apr 25;307(16):1694.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
124
November 2009
November 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • DSM-IV Diagnosis of obsessive compulsive disorder
  • CYBOCS total score greater than 16

Exclusion Criteria:

  • Other primary or co-primary psychiatric disorder
  • Pervasive developmental disorder or disorders, including Asperger's Syndrome
  • Thought disorder
  • Prior failed trial of cognitive-behavioral therapy
  • Has pediatric autoimmune neuropsychiatric disorders associated with streptococcus (PANDAS) or maintenance antibiotic for obsessive-compulsive disorder
  • Mental retardation
  • Pregnancy
Both
7 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00074815
Pro00008097, R01MH055121, DSIR 84-CTM
Yes
Duke University
Duke University
National Institute of Mental Health (NIMH)
Principal Investigator: John S March, MD MPH Duke University
Duke University
November 2012

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