Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00044239
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2002-08-22
Brief Title:
Characterization of Childhood-Onset Obsessive-Compulsive Disorder
Sponsor:
National Institute of Mental Health NIMH
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
The Characterization of Childhood Onset Obsessive Compulsive Disorder and the PANDAS Subgroup
Status:
COMPLETED
Status Verified Date:
2010-05-18
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to learn more about Obsessive-compulsive Disorder OCD in children OCD usually has a slow onset and symptoms that may remain at a stable level over time A subset of children with OCD has a sudden onset and symptoms that fluctuate in severity over time This study will also compare healthy children to those with OCD This is an observational study children who participate will not receive any new or experimental therapies
OCD affects nearly 1 of the pediatric population The symptoms of this illness can interrupt development causing significant psychological distress and producing life-long impairments in social academic and occupational functioning A subgroup of pediatric OCD has been designated by the acronym PANDAS Pediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal Infections This type of OCD is characterized by sudden symptom onset and a relapsing-remitting course of illness exacerbation of symptoms occurs with scarlet fever or strep throat infections This study will identify factors that distinguish children with PANDAS OCD from children with non-PANDAS OCD and will compare both groups to healthy children
Children with OCD and their parents are screened with interviews and a review of the childs medical records Participants have an initial evaluation that includes a psychiatric physical and neuromotor exam neuropsychological testing psychological interviews and a blood test Structural magnetic resonance imaging MRS scans of the brain are also obtained The MRS scan does not use radiation
After the initial evaluation children with OCD have follow-up visits every 6 weeks for 12 to 24 months They are seen yearly for 8 years after the study If they have a significant improvement or worsening of their symptoms they are asked to make a maximum of two extra visits Parents of OCD patients are called four times a year to discuss any changes in the childs condition between yearly visits All participants have a 1-year follow-up visit upon study completion
OCD affects nearly 1 of the pediatric population The symptoms of this illness can interrupt development causing significant psychological distress and producing life-long impairments in social academic and occupational functioning A subgroup of pediatric OCD has been designated by the acronym PANDAS Pediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal Infections This type of OCD is characterized by sudden symptom onset and a relapsing-remitting course of illness exacerbation of symptoms occurs with scarlet fever or strep throat infections This study will identify factors that distinguish children with PANDAS OCD from children with non-PANDAS OCD and will compare both groups to healthy children
Children with OCD and their parents are screened with interviews and a review of the childs medical records Participants have an initial evaluation that includes a psychiatric physical and neuromotor exam neuropsychological testing psychological interviews and a blood test Structural magnetic resonance imaging MRS scans of the brain are also obtained The MRS scan does not use radiation
After the initial evaluation children with OCD have follow-up visits every 6 weeks for 12 to 24 months They are seen yearly for 8 years after the study If they have a significant improvement or worsening of their symptoms they are asked to make a maximum of two extra visits Parents of OCD patients are called four times a year to discuss any changes in the childs condition between yearly visits All participants have a 1-year follow-up visit upon study completion
Detailed Description:
Obsessive-compulsive disorder OCD affects nearly 1 of the pediatric population The intrusive symptoms of this illness can interrupt normative development causing significant psychological distress and producing life-long impairments in social academic and occupational functioning Current research supports a neurobiologic model for OCD Converging lines of evidence suggest that a post-infectious autoimmune-mediated process may be associated with the pathogenesis of some pediatric cases This subgroup has been designated by the acronym PANDAS Pediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal infections The abrupt symptom onset and relapsing-remitting course of illness characteristic of the PANDAS subgroup appears to define a distinct cohort of patients in whom symptom exacerbations occur synchronously with Group A beta-hemolytic streptococcal GABHS infections
We propose to perform prospective longitudinal evaluations of a group of 72 children with recent onset OCD and 72 age-sex-matched healthy volunteers All children will undergo a comprehensive baseline assessment including physical neurological and psychiatric evaluations neuropsychological testing structural MRI and MRS scans and laboratory assays The children with OCD will be evaluated in the NIMH outpatient clinic at six-week intervals for a 28-month period to obtain prospective ratings of neuropsychiatric symptom severity physical and neurological assessments and anti-streptococcal antibody titers At the end of the observation period each OCD patient will be placed into a cohort based on the course of his or her symptoms those displaying an acute onset and episodic course of OCD will be assigned to the episodic group while those children with a gradual onset and stable course will comprise the persistent group We hypothesize that the episodic group will have GABHS infections concurrent with their neuropsychiatric symptoms exacerbations and will meet criteria for the PANDAS subgroup In contrast children in the persistent group are not expected to have distinct periods of relapse nor a temporal association between GABHS infections and worsening of their symptoms We expect that children in the PANDAS subgroup will demonstrate cross-reactive antibodies antistreptococcalantineuronal during symptom exacerbations At the conclusion of the study we will perform group comparisons between the episodic OCD and persistent OCD cohorts as well as between the patients and controls The purpose of these comparisons is to identify baseline markers of membership in the PANDAS subgroup The possibilities include distinctive HLA subtypes quantitative differences in cytokines distribution unique MRS chemical profiles or a specific pattern of deficits on neuropsychological tests of basal ganglia function
We propose to perform prospective longitudinal evaluations of a group of 72 children with recent onset OCD and 72 age-sex-matched healthy volunteers All children will undergo a comprehensive baseline assessment including physical neurological and psychiatric evaluations neuropsychological testing structural MRI and MRS scans and laboratory assays The children with OCD will be evaluated in the NIMH outpatient clinic at six-week intervals for a 28-month period to obtain prospective ratings of neuropsychiatric symptom severity physical and neurological assessments and anti-streptococcal antibody titers At the end of the observation period each OCD patient will be placed into a cohort based on the course of his or her symptoms those displaying an acute onset and episodic course of OCD will be assigned to the episodic group while those children with a gradual onset and stable course will comprise the persistent group We hypothesize that the episodic group will have GABHS infections concurrent with their neuropsychiatric symptoms exacerbations and will meet criteria for the PANDAS subgroup In contrast children in the persistent group are not expected to have distinct periods of relapse nor a temporal association between GABHS infections and worsening of their symptoms We expect that children in the PANDAS subgroup will demonstrate cross-reactive antibodies antistreptococcalantineuronal during symptom exacerbations At the conclusion of the study we will perform group comparisons between the episodic OCD and persistent OCD cohorts as well as between the patients and controls The purpose of these comparisons is to identify baseline markers of membership in the PANDAS subgroup The possibilities include distinctive HLA subtypes quantitative differences in cytokines distribution unique MRS chemical profiles or a specific pattern of deficits on neuropsychological tests of basal ganglia function
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 02-M-0281 | None | None | None |