Protocol Number: 97-M-0126

Title:

Childhood Onset Psychotic Disorders: Characterization and Treatment with Atypical Neuroleptics

Number:

97-M-0126

Summary:

The purpose of this study is to compare the effectiveness and side effects of the drugs clozapine and olanzapine in children and adolescents with schizophrenia and psychoses.

Childhood psychosis is a serious disorder that may have devastating consequences. Effective treatments for the condition are under continual investigation. This study will examine the causes of and offer treatment for childhood psychosis.

Participants in this study will undergo psychological tests, blood and urine tests, electroencephalogram (EEG), electrocardiogram (EKG), and magnetic resonance imaging (MRI) scans of the brain for the first 1 to 2 weeks of the study while taking their regular medications. Participants will then be tapered off their medications over 1 to 3 weeks and will continue to stay off medications for an additional 2 days to 3 weeks. During this time, participants will undergo psychiatric, neurological, and cardiac examinations as well as blood tests. After this period without medications, participants will be randomly assigned to receive either clozapine or olanzapine for 8 weeks. An EEG will be performed prior to treatment and after 6 weeks of study medication. Participants who respond well to the study drugs may continue to receive them through their own physician. Participants who do not respond to either clozapine or olanzapine or cannot tolerate their side effects will be treated individually with other drugs until optimum treatment is identified. Regular telephone updates and in person visits to NIH for repeat testing and MRIs will be conducted.

Sponsoring Institute:

National Institute of Mental Health (NIMH)

Recruitment Detail

Type: Completed Study; data analyses ongoing

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): None

Eligibility Criteria: This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Special Instructions:

Time Required: 3 weeks for new diagnostic evaluation study; 16 weeks for treatment study.

Benefits: All treatment will be free during the inpatient phase of the study. Information regarding diagnosis, test results and educational programming will be available.

This protocol includes return visits every two years for approximately 10 years following initial inpatient stay.

Keyword(s):

Clozapine

Olanzapine

Drug Response

Safety

Childhood Onset Schizophrenia

Schizoaffective Disorder

Multidimensionally Impaired Syndrome

Phenomenology

Biochemical Correlates

Brain Imaging

Recruitment Keyword(s):

Schizophrenia

Childhood Schizophrenia

Psychosis

Schizoaffective Disorder

Condition(s):

Mental Disorder Diagnosed in Childhood

Psychotic Disorder

Schizophrenia

Investigational Drug(s):

None

Investigational Device(s):

None

Interventions:

Drug: Olanzapine

Drug: Clozapine

Supporting Site:

National Institute of Mental Health

Contact(s):

This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Citation(s):

Childhood-onset schizophrenia: an NIMH study in progress

Brief report: translocation involving chromosomes 1 and 7 in a boy with childhood-onset schizophrenia

Smooth pursuit eye movements in childhood onset schizophrenia: quantitative analysis and comparision with ADHD and normal controls

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department Clinical Research Informatics, CC.

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