Completed

Treatment of Pediatric OCD for SRI Partial Responders

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What is being tested

Serotonin reuptake inhibitors management

+ Cognitive behavioral therapy by a psychologist

+ Instructional cognitive behavioral therapy by a psychiatrist

DrugBehavioral
Who is being recruted

Anxiety Disorders

+ Mental Disorders

+ Obsessive-Compulsive Disorder

From 7 to 17 Years
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: September 2003
See protocol details

Summary

Principal SponsorDuke University
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2003

Actual date on which the first participant was enrolled.

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.

Official TitleTreatment of Pediatric OCD for SRI Partial Responders
NCT00074815
Principal SponsorDuke University
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

124 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 7 to 17 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Anxiety DisordersMental DisordersObsessive-Compulsive Disorder

Criteria

2 inclusion criteria required to participate
DSM-IV Diagnosis of obsessive compulsive disorder

CYBOCS total score greater than 16

7 exclusion criteria prevent from participating
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

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
Participants will receive the intervention SRI medication management with a psychiatrist

Group II

Experimental
Participants will receive the following interventions: 1)SRI medication management with a psychiatrist plus, 2) cognitive behavioral therapy with a psychologist.

Group III

Experimental
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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 3 locations

Suspended

Duke Child and Family Study Center

Durham, United StatesOpen Duke Child and Family Study Center in Google Maps
Suspended

University of Pennsylvania, The Center for the Treatment and Study of Anxiety

Philadelphia, United States
Suspended

Rhode Island Hospital

Providence, United States
Completed3 Study Centers