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Screening for Childhood-Onset Psychotic Disorders
This study is currently recruiting participants.
Verified by National Institutes of Health Clinical Center (CC), December 2008
Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00049738
  Purpose

The purpose of this study is to screen and evaluate children with psychotic disorders to establish or confirm their diagnosis and to collect data about their condition. This study will also recruit individuals for various treatment studies.

Childhood psychotic disorders are debilitating conditions in which children have auditory or visual hallucinations and disorganized thoughts. This study will examine psychotic disorders in children in an inpatient setting.

Participants in this study will be admitted to the NIH Clinical Center for up to 9 weeks under one or more of the following conditions: current medication, no medication, or tapered medication. Participants will undergo blood, urine, metabolic, and intellectual functioning tests. An electrocardiogram (EKG) and electroencephalogram (EEG) will be performed. A magnetic resonance imaging (MRI) scan of the brain will be taken and infrared oculography will be used to measure eye movements. Participants and their family members may also be asked to participate in a study of genetics in children with psychotic illnesses. Children meeting criteria for childhood onset schizophrenia may be offered participation in a medication comparison protocol.


Condition
Childhood Onset Psychotic Disorders
Schizophrenia

MedlinePlus related topics: Psychotic Disorders Schizophrenia
U.S. FDA Resources
Study Type: Observational
Official Title: Screening, Evaluation, Diagnosis, Treatment Optimization and Follow-up for Childhood Onset Psychotic Disorders

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 150
Study Start Date: October 2002
Detailed Description:

Children and adolescents ages 5 to 18 years, meeting DSM IV criteria for schizophrenia, schizoaffective disorder, and psychotic disorder not otherwise specified, are currently under study in our group. The purpose of this protocol is to allow systematic outpatient, and subsequent inpatient screening evaluation to establish an accurate diagnosis for research, obtain clinical and neurobiological research measurements, evaluate the patient's response to open treatment with antipsychotic(s), and allow longitudinal followup. Subjects and first degree relatives may then be enrolled in protocol 89-M-0006, Brain Imaging of Childhood Onset Psychiatric Disorders, Endocrine Disorders and Healthy Controls, and Protocol 84-M-0050, Biochemical, Physiological, and Psychological Measures in Normal Controls and Relatives of Psychiatric Patients. If additional research protocols are available, this screening protocol will represent an entry point for them.

The evaluation process will include a one day outpatient psychiatric screening interview with proband and family. If it is thought that the child is likely to meet criteria for childhood onset psychoses, an inpatient evaluation will then be offered for clarifying the diagnosis. This may involve: 1) Up to 3 weeks of inpatient observation on the child's current medication regimen. 2) Tapering of psychotropic medications (1-4 weeks, depending upon type and dosage). 3) Observation for up to 3 weeks drug free, in order to confirm the diagnosis, and 4) Once the diagnosis is confirmed, two to ten weeks of treatment with antipsychotic(s); 5) Discharge to the care of his/her community psychiatrist. Treatment will be guided by what is considered the subject's best clinical interest. During the inpatient stay, or occasionally as part of the outpatient screening, we will obtain neuropsychological testing, research blood draws including blood for genetic testing of the proband, and a research brain MRI scan.

  Eligibility

Ages Eligible for Study:   5 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

Boys and girls age 5-18.

Onset of psychotic symptoms before 13th birthday and a presumptive diagnosis of either schizophrenia, schizoaffective disorder, MDI syndrome, or psychosis NOS.

Pre-psychotic IQ 70 or above.

EXCLUSION CRITERIA:

Major neurological or medical condition (e.g. temporal lobe epilepsy for which patient is on active treatment), or other psychiatric diagnosis that is the main focus of treatment (e.g. serious eating disorder).

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00049738

Contacts
Contact: Patient Recruitment and Public Liaison Office (800) 411-1222 prpl@mail.cc.nih.gov
Contact: TTY 1-866-411-1010

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

NIH Clinical Center Detailed Web Page  This link exits the ClinicalTrials.gov site

Publications:
Study ID Numbers: 030035, 03-M-0035
Study First Received: November 12, 2002
Last Updated: December 30, 2008
ClinicalTrials.gov Identifier: NCT00049738  
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Schizophrenia
MDI
Schizoaffective
Schizophrenia
Schizoaffective
Psychotic Disorder
Multidimensionally Impaired Syndrome

Study placed in the following topic categories:
Schizophrenia
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:
Pathologic Processes
Disease

ClinicalTrials.gov processed this record on January 30, 2009