Cognitive Behavioral Therapy for Pediatric Obsessive-Compulsive Disorder - Full Text View

Sponsored by:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00748761

Purpose

This study will examine the way cognitive behavioral therapy changes the structure of the brain in patients with obsessive-compulsive disorder and will thereby determine what makes cognitive behavioral therapy an effective treatment.

Condition	Intervention
Obsessive-Compulsive Disorder	Behavioral: Cognitive Behavioral Therapy (CBT) Behavioral: Waitlist

MedlinePlus related topics: Obsessive-Compulsive Disorder

Drug Information available for: Glutamic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment
Official Title:	Cognitive-Behavioral Therapy & Glutametergic Neurometabolites in Pediatric OCD

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

Primary Outcome Measures:

Regional concentration of glutamate and glutamine in brain, as measured by Magnetic Resonance Spectroscopic Imaging (MRSI) [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall score on child Yale-Brown Obsessive-Compulsive Scale [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	108
Study Start Date:	June 2008
Estimated Study Completion Date:	May 2013
Estimated Primary Completion Date:	May 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental Children with obsessive-compulsive disorder (OCD) will be treated with cognitive behavioral therapy (CBT) from the time of enrollment.	Behavioral: Cognitive Behavioral Therapy (CBT) Nondrug psychotherapy administered weekly for 12 weeks
B: Active Comparator Children with OCD will receive waitlist treatment at enrollment. Nonresponders will cross over to CBT.	Behavioral: Cognitive Behavioral Therapy (CBT) Nondrug psychotherapy administered weekly for 12 weeks Behavioral: Waitlist Contact waitlist weekly for 12 weeks
C: No Intervention Healthy control children will be given no intervention.

Detailed Description:

Obsessive-compulsive disorder (OCD) afflicts 2% to 4% of children and adolescents, who suffer from persistent, unwanted thoughts and repetitive behaviors. One of the most effective treatments of OCD is cognitive behavioral therapy (CBT), yet researchers do not know how CBT affects the brain. In this study, brain scans will be performed to determine concentrations of several neurometabolites, which are chemicals involved in providing energy to the brain. Of particular importance are the neurometabolites glutamine and glutamate, which, in addition to providing energy to the brain, are among the most common excitatory neurotransmitters. Disruption of glutamine and glutamate is thought to be related to OCD. By examining where in the brain levels of glutamate and glutamine change, researchers will attempt to determine whether CBT modifies brain activity, whether a circuit targeted by researchers is affected by CBT, and how brain activity in people with OCD differs from that of people without the disorder in terms of the targeted circuit.

Children and adolescents ages 8 through 17 with OCD will be randomly assigned to either receive a 12-week CBT intervention or be placed on a waiting list for 8 weeks before receiving the 12-week intervention. A group of non-OCD participants in the same age group will be used as a control. All groups will undergo magnetic resonance spectroscopic imaging (MRSI), which will measure the concentrations of neurometabolites in multiple brain regions. The control group and the group initially given the CBT intervention will be scanned upon entry of the study and after 12 weeks. The group initially placed on a waiting list will be scanned three times: once upon entry, once after the 8-week waiting period, and once after the 12-week CBT intervention. To determine which participants are benefitting from the treatment, the Yale-Brown Obsessive-Compulsive Scale and other clinical and neurocognitive measures will be administered concurrently with each brain scan.

Eligibility

Ages Eligible for Study:	6 Years to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Meets DSM-IV diagnostic criteria for OCD as primary diagnosis, based on the Anxiety Disorders Interview Schedule (ADIS) Clinical Severity Rating
Clinical Global Impressions severity score of at least 4, reflecting moderately ill or worse status
Children's Yale-Brown Obsessive Compulsive Scale total score of greater than or equal to 16
No medication for OCD or other psychiatric condition in the past 4 weeks and no use of fluoxetine for the past 6 weeks
Child is fluent in English
Parental informed consent and child or adolescent informed assent forms are signed
For females of childbearing potential a negative pregnancy test will be required for study entry

Exclusion Criteria:

IQ of less than 80 on the Wechsler Abbreviated Scales of Intelligence
A lifetime DSM-IV diagnosis of pervasive developmental disorder, mania, psychosis, conduct disorder, or substance dependence assessed through ADIS
Current DSM-IV diagnosis of major depressive disorder or attention deficit hyperactivity disorder any subtype, assessed through an ADIS rating of 4 or higher
Any serious psychiatric, psychosocial, or neurological condition, such as a tic disorder, non-OCD anxiety, aggression, or family discord, that requires immediate treatment other than that provided in the current study
One or more failed adequate trials of exposure-based CBT, defined as at least 10 sessions of therapist-assisted, exposure-based CBT with which the patient voluntarily complied
More than one failed selective serotonin reuptake inhibitor trial adequate in dose and duration, defined as at least 8 weeks of treatment with at least 20 mg of fluoxetine, 20 mg of paroxetine, 75 mg of sertraline or fluvoxamine, or 75mg of clomipramine
Any body metal (other than dental fillings), pregnancy, or other contraindications to MRSI scan

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00748761

Contacts

Contact: John C. Piacentini, PhD

310-206-6649

jcp@ucla.edu

Locations

United States, California
UCLA Child Psychiatry	Recruiting
Los Angeles, California, United States, 90024

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:	Joseph O'Neill, PhD	UCLA Child Psychiatry
Principal Investigator:	John C. Piacentini, PhD	UCLA Child Psychiatry

More Information

Responsible Party:	UCLA Child Psychiatry ( Joseph O'Neill, PhD/Principal Investigator )
Study ID Numbers:	R01 MH081864, DDTR B2-NDO
Study First Received:	September 8, 2008
Last Updated:	September 18, 2008
ClinicalTrials.gov Identifier:	NCT00748761
Health Authority:	United States: Federal Government

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

Obsessive-Compulsive Disorder
OCD
Cognitive-Behavioral Therapy

CBT
MRSI
Glutamate

Study placed in the following topic categories:

Anxiety Disorders
Mental Disorders
Obsessive-Compulsive Disorder

Additional relevant MeSH terms:

Pathologic Processes
Disease

ClinicalTrials.gov processed this record on January 30, 2009