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Clinical Trial Summary

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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

NCT number NCT00049738
Study type Observational
Source National Institutes of Health Clinical Center (CC)
Status Terminated
Phase N/A
Start date October 29, 2002
Completion date October 5, 2017

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