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Completed

NCT Number: NCT00074815

Treatment of Obsessive Compulsive Disorder in Children

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.

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Key information

Conditions

Obsessive-Compulsive Disorder Anxiety Disorders Mental Disorders

Age range

7 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Duke Child and Family Study Center, Durham, North Carolina, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Serotonin reuptake inhibitors management

Drug

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;

Cognitive behavioral therapy by a psychologist

Behavioral

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.

Instructional cognitive behavioral therapy by a psychiatrist

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Child Obsessive -Compulsive Impact Scale (COIS)

    Time frame: Measured at baseline; Weeks 4, 8, and 12; and Months 3 and 6 of follow-up

  2. Child Depression Inventory

    Time frame: Measured at baseline; Weeks 4, 8, and 12; and Months 3 and 6 of follow-up

  3. Pediatric Adverse Event Rating Scale (PAERS)

    Time frame: Measured at baseline; Weeks 4, 8, and 12; and Months 3 and 6 of follow-up

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Treatment of Pediatric OCD for SRI Partial Responders

Important dates

Study start
2003
Primary completion
2009
Study completion
2009
First posted
Dec 22, 2003
Registry last updated
Jul 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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