Treatment of Obsessive Compulsive Disorder in Children - Full Text View

Purpose

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.

Condition	Intervention	Phase
Obsessive-Compulsive Disorder	Drug: Serotonin reuptake inhibitors management Behavioral: Cognitive behavioral therapy by a psychologist Behavioral: Instructional cognitive behavioral therapy by a psychiatrist	Phase III

MedlinePlus related topics:

Obsessive-Compulsive Disorder

ChemIDplus related topics:

Sertraline hydrochloride Sertraline Fluoxetine Escitalopram Benzetimide Citalopram Citalopram hydrobromide Dexetimide Escitalopram oxalate Paroxetine Paroxetine hydrochloride Paroxetine Mesylate Serotonin Venlafaxine Venlafaxine hydrochloride Fluoxetine hydrochloride Clomipramine Clomipramine hydrochloride Fluvoxamine maleate Fluvoxamine

U.S. FDA Resources

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

Official Title:	Treatment of Pediatric OCD for SRI Partial Responders

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:

Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) [ Time Frame: Measured at baseline; Weeks 4, 8, and 12; and Months 3 and 6 of follow-up ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	150
Study Start Date:	September 2003
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
MM + CBT: Experimental Participants will receive medication management plus 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. 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.
MM + ICBT: Experimental Participants will receive medication management plus instructional cognitive behavioral therapy 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. 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.
MM only: Active Comparator Participants will receive medication management only	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.

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.

Eligibility

Ages Eligible for Study:	7 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00074815

Locations


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

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

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

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators


Principal Investigator:	John S March, MD MPH	Duke University

More Information

Duke Program in Child Affective and Anxiety Disorders This link exits the ClinicalTrials.gov site

Responsible Party:	Duke University Medical Center ( John S. March, MD, MPH )
Study ID Numbers:	R01 MH55121, DSIR 84-CTM
First Received:	December 19, 2003
Last Updated:	September 17, 2008
ClinicalTrials.gov Identifier:	NCT00074815
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

Child

Adolescent

Study placed in the following topic categories:

Fluoxetine

Fluvoxamine

Anxiety Disorders

Mental Disorders

Clomipramine

Venlafaxine

Sertraline

Dexetimide

Paroxetine

Citalopram

Serotonin

Obsessive-Compulsive Disorder

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors

Neurotransmitter Agents

Disease

Molecular Mechanisms of Pharmacological Action

Physiological Effects of Drugs

Psychotropic Drugs

Serotonin Uptake Inhibitors

Pharmacologic Actions

Pathologic Processes

Serotonin Agents

Therapeutic Uses

Antidepressive Agents, Second-Generation

Central Nervous System Agents

Antidepressive Agents

ClinicalTrials.gov processed this record on October 10, 2008

Sponsored by:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00074815