NCT00044239

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 child's 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 child's condition between yearly visits. All participants have a 1-year follow-up visit upon study completion.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2002

Longer than P75 for all trials

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 20, 2002

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

August 22, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 23, 2002

Completed
7.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 18, 2010

Completed
Last Updated

July 2, 2017

Status Verified

May 18, 2010

First QC Date

August 22, 2002

Last Update Submit

June 30, 2017

Conditions

Keywords

Tic DisordersNeurophyschologicalImmunologyMagnetic Resonance ImagingBasal GangliaObsessive-Compulsive DisorderChildrenAdolescentsMagnetic Resonance SpectroscopyPANDAS (Pediatric Autoimmune Neuropsychiatric Disorders Associated dObsessive Compulsive DisorderOCDHealthy VolunteersHV

Eligibility Criteria

Age4 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • OCD Participants (N = 72)
  • Aged 4-12 years and living within a four-hour commute from NIH
  • Currently meet DSM-IV criteria for OCD.
  • Recent onset of symptoms (less than 6 months.)
  • Healthy Controls (N = 60-72)
  • Age and sex matched to ODC participants.
  • Must be free of current or past psychopathology.

You may not qualify if:

  • OCD Participants:
  • Diagnosis of schizophrenia, schizoaffective, bipolar, delusional, or psychotic disorder; autistic spectrum disorder or pervasive developmental disorder; neurologic disorder other than tics; or rheumatic fever.
  • Significant or unstable medical illness.
  • Full scale IQ less than 80.
  • Healthy Controls:
  • Full scale IQ less than 80.
  • Significant or unstable medical illness.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University of Arkansas

Little Rock, Arkansas, 72205, United States

Location

University of Florida

Gainesville, Florida, 32610-0296, United States

Location

Cornell University

New York, New York, 10021-4872, United States

Location

Utah State University

Logan, Utah, 84322, United States

Location

Related Publications (3)

  • Rosenberg DR, Keshavan MS, O'Hearn KM, Dick EL, Bagwell WW, Seymour AB, Montrose DM, Pierri JN, Birmaher B. Frontostriatal measurement in treatment-naive children with obsessive-compulsive disorder. Arch Gen Psychiatry. 1997 Sep;54(9):824-30. doi: 10.1001/archpsyc.1997.01830210068007.

    PMID: 9294373BACKGROUND
  • Snider LA, Lougee L, Slattery M, Grant P, Swedo SE. Antibiotic prophylaxis with azithromycin or penicillin for childhood-onset neuropsychiatric disorders. Biol Psychiatry. 2005 Apr 1;57(7):788-92. doi: 10.1016/j.biopsych.2004.12.035.

    PMID: 15820236BACKGROUND
  • Saxena S, Brody AL, Schwartz JM, Baxter LR. Neuroimaging and frontal-subcortical circuitry in obsessive-compulsive disorder. Br J Psychiatry Suppl. 1998;(35):26-37.

    PMID: 9829024BACKGROUND

MeSH Terms

Conditions

Obsessive-Compulsive DisorderTic DisordersPediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal infections

Condition Hierarchy (Ancestors)

Anxiety DisordersMental DisordersMovement DisordersCentral Nervous System DiseasesNervous System DiseasesNeurodevelopmental Disorders

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

August 22, 2002

First Posted

August 23, 2002

Study Start

August 20, 2002

Study Completion

May 18, 2010

Last Updated

July 2, 2017

Record last verified: 2010-05-18

Locations