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: Active Accrual Of New Subjects

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): None

Eligibility Criteria:

INCLUSION CRITERIA:

Males and females, age 8 to 18 years

Onset of psychotic symptoms before 13th birthday and a DSM-IV diagnosis of either schizophrenia, schizoaffective disorder, MDI syndrome, or psychosis NOS (not otherwise specified).

Current significant impairment due to the illness (current psychotic symptoms, decline of functioning academically and socially, significant discomfort due to psychotic symptoms).

Failure of two prior trials with antipsychotic medications (either typical or atypical) used at adequate doses (greater than or equal to 100 mg/day in chlorpromazine equivalents) and for adequate duration (at least 4 weeks, unless terminated due to intolerable side effects). Failure is defined as either insufficient response with persistence of symptoms significantly impairing child's functioning, according to child's and parental reports and medical and school records, or intolerable side effects to drugs other than clozapine and olanzapine.

Subjects may be included if their previous trial(s) of olanzapine failed to reach the dose of 20. mg/day or a duration of fewer than four weeks.

Subjects may be included if their previous trial(s) of clozapine failed to reach the dose of 200. mg/day or a duration of fewer than six weeks.

Comorbid psychiatric disorders in the past 12 months are permitted as long as not clinically significant.

EXCLUSION CRITERIA:

Prepsychotic full-scale IQ less than 70.

Unstable major neurological or medical conditions.

Current pregnancy or plan to become pregnant during the first three months (the duration of the study) in woman of childbearing age; breast-feeding in woman with infants.

DSM-IV substance abuse or dependence in the past 6 months.

True non-responders to either olanzapine or clozapine. True non-response is defined as: a) intolerance to either of the medications preventing an adequate trial, or b) only minimal (less than 20%) benefit with the adequate trial of either of the medications. Adequate trial constitutes at least 8 weeks of the medication with the dose of 20 mg on olanzapine or 200 mg of clozapine.

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.

Keywords:

Clozapine

Olanzapine

Drug Response

Safety

Childhood Onset Schizophrenia

Schizoaffective Disorder

Multidimensionally Impaired Syndrome

Phenomenology

Biochemical Correlates

Brain Imaging

Recruitment Keywords:

Schizophrenia

Childhood Schizophrenia

Psychosis

Schizoaffective Disorder

Conditions:

Mental Disorder Diagnosed in Childhood

Psychotic Disorder

Schizophrenia

Investigational Drug(s):

None

Investigational Device(s):

None

Contacts:

Margaret L. Lenane, L.C.S.W.
National Institutes of Health
Building 10
Room 3N202
10 Center Drive
Bethesda, Maryland 20892
Phone: (301) 496-7962
Fax: (301) 402-0296

Electronic Address: mlenane@box-m.nih.gov

Citations:

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

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