Treatment of Obsessive Compulsive Disorder in Children

July 23, 2014 updated by: Duke University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

124

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke Child And Family Study Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania, The Center for the Treatment and Study of Anxiety
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Rhode Island Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MedMgmt+CBT
Participants will receive the following interventions: 1)SRI medication management with a psychiatrist plus, 2) cognitive behavioral therapy with a psychologist.
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.
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.
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: 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.
Active Comparator: MedMgmt Only
Participants will receive the intervention SRI medication management with a psychiatrist
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;

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)
Time Frame: Measured at baseline and Week 12.

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.
Measured at baseline and Week 12.

Secondary Outcome Measures

Outcome Measure
Time Frame
Child Obsessive -Compulsive Impact Scale (COIS)
Time Frame: Measured at baseline; Weeks 4, 8, and 12; and Months 3 and 6 of follow-up
Measured at baseline; Weeks 4, 8, and 12; and Months 3 and 6 of follow-up
Child Depression Inventory
Time Frame: Measured at baseline; Weeks 4, 8, and 12; and Months 3 and 6 of follow-up
Measured at baseline; Weeks 4, 8, and 12; and Months 3 and 6 of follow-up
Pediatric Adverse Event Rating Scale (PAERS)
Time Frame: Measured at baseline; Weeks 4, 8, and 12; and Months 3 and 6 of follow-up
Measured at baseline; Weeks 4, 8, and 12; and Months 3 and 6 of follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: John S March, MD MPH, Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2003

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

December 19, 2003

First Submitted That Met QC Criteria

December 19, 2003

First Posted (Estimate)

December 22, 2003

Study Record Updates

Last Update Posted (Estimate)

July 29, 2014

Last Update Submitted That Met QC Criteria

July 23, 2014

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00008097
  • DSIR 84-CTM
  • R01MH055121 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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