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Screening for Childhood-Onset Psychotic Disorders

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )
ClinicalTrials.gov Identifier:
NCT00049738
First received: November 12, 2002
Last updated: November 11, 2014
Last verified: June 2014
  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
Psychosis
Psychotic Disorder

Study Type: Observational
Official Title: Screening, Evaluation, Diagnosis, Treatment Optimization and Follow-up for Childhood Onset Psychotic Disorders

Resource links provided by NLM:


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

Estimated Enrollment: 250
Study Start Date: October 2002
Detailed Description:

Children and adolescents ages 5 to 18, 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 follow-up. 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. A skin biopsy may be obtained either during the inpatient stay or a follow up visit.

This protocol also includes a study 100 non-schizophrenic children ages 6-13 with psychotic symptoms (e.g. hallucinations or delusions) to extend our studies of early neuro-developmental biomarkers and of the factors that either promote or stop the progression to full schizophrenia (resilience or conversion factors). These children will be recruited from the local community, evaluated as outpatients and followed prospectively for five years. Measures will include diagnostic interviews, clinical ratings, cognitive testing, anatomic and functional imaging, and blood for routine and genetic testing.

  Eligibility

Ages Eligible for Study:   5 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INPATIENT STUDY

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).

OUTPATIENT STUDY:

INCLUSION CRITERIA:

  1. Age 6 to 13 years old
  2. Presence of psychotic symptoms

EXCLUSION CRITERIA:

  1. Major medical or neurological illness
  2. IQ below 70, based on either test data or clinical assessment.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts
Contact: Judith L Rapoport, M.D. (301) 435-4501 rapoporj@mail.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Judith L Rapoport, M.D. National Institute of Mental Health (NIMH)
  More Information

Additional Information:
Publications:
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )
ClinicalTrials.gov Identifier: NCT00049738     History of Changes
Other Study ID Numbers: 030035, 03-M-0035
Study First Received: November 12, 2002
Last Updated: November 11, 2014
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Disease
Mental Disorders
Psychotic Disorders
Schizophrenia
Pathologic Processes
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on November 25, 2014