Treatment of Obsessive Compulsive Disorder in Children

Condition(s) targeted: Obsessive-Compulsive Disorder

Intervention: Serotonin reuptake inhibitors management (Drug); Cognitive behavioral therapy by a psychologist (Behavioral); Instructional cognitive behavioral therapy by a psychiatrist (Behavioral)

Phase: Phase 3

Status: Recruiting

Sponsored by: National Institute of Mental Health (NIMH)

Official(s) and/or principal investigator(s):
John S March, MD MPH, Principal Investigator, Affiliation: Duke University

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.

Official title: Treatment of Pediatric OCD for SRI Partial Responders

Study design: Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study

Primary outcome: Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)

Secondary outcome:

Child Obsessive -Compulsive Impact Scale (COIS)

Child Depression Inventory

Pediatric Adverse Event Rating Scale (PAERS)

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.

Minimum age: 7 Years. Maximum age: 17 Years. Gender(s): Both.

Criteria:

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

Duke Child and Family Study Center, Durham, North Carolina 27705, United States; Recruiting
Jeffrey Sapyta, PhD, Phone: 919-416-2451, Email: jeffrey.sapyta@duke.edu
Denny Hood, BA, Phone: 919-416-2410, Email: hood0010@mc.duke.edu
John S. March, MD, MPH, Principal Investigator

University of Pennsylvania, The Center for the Treatment and Study of Anxiety, Philadelphia, Pennsylvania 19104, United States; Recruiting
Sophia Talbott, BA, Phone: 215-746-3337, Email: talbott@mail.med.upenn.edu
Martin Franklin, PhD, Principal Investigator

Rhode Island Hospital, Providence, Rhode Island 02903, United States; Recruiting
Jennifer Freeman, PhD, Phone: 401-444-2568, Email: jfreeman@lifespan.org
Nancy Haff, BA, Phone: 401-444-2178, Email: nhaff@lifespan.org
Jennifer Freeman, PhD, Principal Investigator

Duke Program in Child Affective and Anxiety Disorders

Starting date: September 2003
Ending date: September 2009
Last updated: September 17, 2008