Treatment of Obsessive Compulsive Disorder in Children - Full Text View

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

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Treatment of Pediatric OCD for SRI Partial Responders

Resource links provided by NLM:

MedlinePlus related topics: Anxiety Obsessive-Compulsive Disorder

Drug Information available for: Serotonin Benzetimide Clomipramine hydrochloride Dexetimide Fluvoxamine Fluoxetine Fluoxetine hydrochloride Citalopram hydrobromide Citalopram Fluvoxamine maleate Paroxetine Paroxetine hydrochloride Sertraline hydrochloride Sertraline Venlafaxine Venlafaxine hydrochloride Paroxetine hydrochloride hemihydrate Escitalopram Paroxetine Mesylate Escitalopram oxalate Clomipramine

U.S. FDA Resources

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
Experimental: MM + CBT 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. 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: MM + ICBT 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. 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: MM only 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. 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;

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

Additional Information:

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

No publications provided by National Institute of Mental Health (NIMH)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Franklin ME, Sapyta J, Freeman JB, Khanna M, Compton S, Almirall D, Moore P, Choate-Summers M, Garcia A, Edson AL, Foa EB, March JS. Cognitive behavior therapy augmentation of pharmacotherapy in pediatric obsessive-compulsive disorder: the Pediatric OCD Treatment Study II (POTS II) randomized controlled trial. JAMA. 2011 Sep 21;306(11):1224-32.

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

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

Child
Adolescent

Additional relevant MeSH terms:

Obsessive-Compulsive Disorder
Anxiety Disorders
Mental Disorders
Clomipramine
Paroxetine
Venlafaxine
Serotonin Uptake Inhibitors
Serotonin
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs

Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs
Serotonin Receptor Agonists
Antidepressive Agents, Second-Generation

ClinicalTrials.gov processed this record on February 12, 2012