| December 19, 2003 |
| September 17, 2008 |
| September 2003 |
| March 2009 (final data collection date for primary outcome measure) |
| 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 ] |
| 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 ] |
| Complete list of historical versions of study NCT00074815 on ClinicalTrials.gov Archive Site |
- 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 ]
|
- 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 ]
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| |
| Treatment of Obsessive Compulsive Disorder in Children |
| Treatment of Pediatric OCD for SRI Partial Responders |
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. |
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. |
| Phase III |
| Interventional |
| Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
| Obsessive-Compulsive Disorder |
- Drug: Serotonin reuptake inhibitors management
- Behavioral: Cognitive behavioral therapy by a psychologist
- Behavioral: Instructional cognitive behavioral therapy by a psychiatrist
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- Experimental: Participants will receive medication management plus cognitive behavioral therapy with a psychologist
- Experimental: Participants will receive medication management plus instructional cognitive behavioral therapy with a psychiatrist
- Active Comparator: Participants will receive medication management only
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| |
| |
| Recruiting |
| 150 |
| September 2009 |
| March 2009 (final data collection date for primary outcome measure) |
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
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| Both |
| 7 Years to 17 Years |
| No |
|
| United States |
| |
| NCT00074815 |
| John S. March, MD, MPH, Duke University Medical Center |
| R01 MH55121, DSIR 84-CTM |
| National Institute of Mental Health (NIMH) |
|
| Principal Investigator: |
John S March, MD MPH |
Duke University |
|
|
| National Institute of Mental Health (NIMH) |
| September 2008 |