|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT00074815 |
|
Date of registration:
|
19/12/2003 |
|
Primary sponsor: |
|
|
Public title:
|
Treatment of Obsessive Compulsive Disorder in Children
|
|
Scientific title:
|
Treatment of Pediatric OCD for SRI Partial Responders |
|
Date of first enrolment:
|
September 2003 |
|
Target sample size:
|
124 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT00074815 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
John S March, MD MPH |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Duke University |
| | |
|
Key inclusion & exclusion 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
Age minimum:
7 Years
Age maximum:
17 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Obsessive-Compulsive Disorder
|
|
Intervention(s)
|
|
Behavioral: Cognitive behavioral therapy by a psychologist
|
|
Behavioral: Instructional cognitive behavioral therapy by a psychiatrist
|
|
Drug: Serotonin reuptake inhibitors management
|
|
Primary Outcome(s)
|
|
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]
|
|
Secondary Outcome(s)
|
|
Child Depression Inventory
[Time Frame: Measured at baseline; Weeks 4, 8, and 12; and Months 3 and 6 of follow-up]
|
|
Child Obsessive -Compulsive Impact Scale (COIS)
[Time Frame: Measured at baseline; Weeks 4, 8, and 12; and Months 3 and 6 of follow-up]
|
|
Pediatric Adverse Event Rating Scale (PAERS)
[Time Frame: Measured at baseline; Weeks 4, 8, and 12; and Months 3 and 6 of follow-up]
|
|
Secondary ID(s)
|
|
DSIR 84-CTM
|
|
R01 MH55121
|
|
R01MH055121
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|