Treatment of Obsessive Compulsive Disorder in Children
This study has been completed.
Sponsor:
Duke University
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00074815
First received: December 19, 2003
Last updated: July 23, 2014
Last verified: November 2012
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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 3 |
| 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:
Drug Information available for:
Serotonin
Clomipramine
Fluvoxamine
Paroxetine
Venlafaxine
Venlafaxine hydrochloride
U.S. FDA Resources
Further study details as provided by Duke University:
Primary Outcome Measures:
- Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) [ Time Frame: Measured at baseline and Week 12. ] [ Designated as safety issue: Yes ]
OCD symptom severity was measured using the CY-BOCS, an interviewer-rated instrument that assess obsessions and compulsions separately on time consumed, distress, interference, degree of resistance, and control; it yields separate severity scores for obsessions and for compulsions (0 - 20), and a composite symptom severity score (0 to 40).
Consistent with signal detection analyses examining the optimal criterion for treatment response, a CY-BOCS reduction of 30% or more from baseline to week 12 was used as the criterion for RESPONSE and was the primary dichotomous outcome measure.
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 ]
| Enrollment: | 124 |
| Study Start Date: | September 2003 |
| Study Completion Date: | November 2009 |
| Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: MedMgmt+CBT
Participants will receive the following interventions: 1)SRI medication management with a psychiatrist plus, 2) 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:
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: MedMgmt+I-CBT
Participants will receive the following interventions 1)SRI medication management plus, 2) instructional cognitive behavioral therapy. Both of these will be implemented by the same 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:
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: MedMgmt Only
Participants will receive the intervention SRI medication management 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:
|
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 (Child) |
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00074815
Please refer to this study by its ClinicalTrials.gov identifier: NCT00074815
Locations
| United States, North Carolina | |
| Duke Child and Family Study Center | |
| Durham, North Carolina, United States, 27705 | |
| United States, Pennsylvania | |
| University of Pennsylvania, The Center for the Treatment and Study of Anxiety | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| United States, Rhode Island | |
| Rhode Island Hospital | |
| Providence, Rhode Island, United States, 02903 | |
Sponsors and Collaborators
Duke University
National Institute of Mental Health (NIMH)
Investigators
| Principal Investigator: | John S March, MD MPH | Duke University |
More Information
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Duke University |
| ClinicalTrials.gov Identifier: | NCT00074815 History of Changes |
| Other Study ID Numbers: | Pro00008097 R01MH055121 DSIR 84-CTM |
| Study First Received: | December 19, 2003 |
| Results First Received: | November 15, 2012 |
| Last Updated: | July 23, 2014 |
| Health Authority: | United States: Federal Government |
Keywords provided by Duke University:
|
Child Adolescent |
Additional relevant MeSH terms:
|
Compulsive Personality Disorder Obsessive-Compulsive Disorder Compulsive Behavior Personality Disorders Mental Disorders Anxiety Disorders Impulsive Behavior Paroxetine Fluvoxamine Serotonin Uptake Inhibitors Clomipramine Venlafaxine Hydrochloride Serotonin Neurotransmitter Uptake Inhibitors Membrane Transport Modulators |
Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Serotonin Agents Physiological Effects of Drugs Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Cytochrome P-450 CYP2D6 Inhibitors Cytochrome P-450 Enzyme Inhibitors Enzyme Inhibitors Serotonin and Noradrenaline Reuptake Inhibitors Serotonin Receptor Agonists Anti-Anxiety Agents Tranquilizing Agents Central Nervous System Depressants |
ClinicalTrials.gov processed this record on September 30, 2016