Screening for Childhood-Onset Psychotic Disorders

October 6, 2017 updated by: National Institute of Mental Health (NIMH)

Screening, Evaluation, Diagnosis, Treatment Optimization and Follow-up for Childhood Onset Psychotic Disorders

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.

Study Overview

Detailed Description

Up to 250 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 neurocognitive 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, neurocognitive testing, anatomic and functional imaging, and blood for routine and genetic testing.

Study Type

Observational

Enrollment (Actual)

123

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Institutes of Health Clinical Center, 9000 Rockville Pike

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 99 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • INCLUSION CRITERIA:
  • Males and females between the ages of 5 and 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Accurate Diagnosis
Time Frame: On going
On going

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Judith L Rapoport, M.D., National Institute of Mental Health (NIMH)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 29, 2002

Study Completion

October 5, 2017

Study Registration Dates

First Submitted

November 12, 2002

First Submitted That Met QC Criteria

November 12, 2002

First Posted (Estimate)

November 13, 2002

Study Record Updates

Last Update Posted (Actual)

October 9, 2017

Last Update Submitted That Met QC Criteria

October 6, 2017

Last Verified

October 5, 2017

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Schizophrenia

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