At a glance
ClinicalIndex Comparison Record- ✓Age 7 to 18 years
- ✓Onset of psychotic symptoms before 13th birthday with DSM-IV diagnosis of schizophrenia, schizoaffective disorder, MDI syndrome, or psychosis NOS
- ✓Current significant impairment due to psychotic illness (active symptoms, academic/social decline, significant distress)
- ✓Failure of at least two prior antipsychotic trials at adequate doses (≥100 mg/day chlorpromazine equivalents) and adequate duration (≥4 weeks, or less if intolerable side effects)
- ✕Prepsychotic full-scale IQ less than 70
- ✕Unstable major neurological or medical conditions
- ✕Pregnancy, planned pregnancy in first 3 months, or breast-feeding
- ✕DSM-IV substance abuse or dependence in past 6 months
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Childhood Onset Psychotic Disorders: Characterization and Treatment With Atypical Neuroleptics
In Brief
A Phase 4 clinical trial evaluating Olanzapine and Clozapine for Childhood Schizophrenia and 2 related conditions. Completed, enrolled 25 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
tablet; 5-20mg/day; 8 weeks
tablet; 12.5-900mg/day; 8 weeks