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Treatment of Obsessive Compulsive Disorder in Children

This study is currently recruiting participants.
Verified by National Institute of Mental Health (NIMH), September 2008

Sponsored by: 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

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

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




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