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NCT00001656 · ClinicalTrials.gov registry record · Phase 4
Comparison of Clozapine vs Olanzapine in Childhood-Onset Psychotic Disorders
A Phase 4 study, sponsored by National Institute of Mental Health (NIMH).
- Completed
- Registry status
- Phase 4
- Development phase
- 25
- Enrollment target
NCT00001656: Completed Phase 4 study, sponsored by National Institute of Mental Health (NIMH).
NCT00001656 is a Phase 4 study that has completed, run by National Institute of Mental Health (NIMH). The registered enrollment target is 25 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00001656, a Phase 4 study, has completed, sponsored by National Institute of Mental Health (NIMH).
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 25 participants
- Enrollment target
Study 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.
Primary Outcome
Measures change in affective flattening or blunting, alogia, avolition/apathy, anhedonia/asociality, attention; minimum score = 0; maximum score = 125; lower values are considered a better outcome
Interventions
- DRUG Olanzapine
- DRUG Clozapine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 1997-06 |
| Est. Completion | 2008-06 |
| Phase | Phase 4 |
What the finished NCT00001656 record still lists
NCT00001656 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which Olanzapine is the first listed.
NCT00001656 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00001656 about?
NCT00001656 is a clinical study titled "Comparison of Clozapine vs Olanzapine in Childhood-Onset Psychotic Disorders". 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...
What is the current status of trial NCT00001656?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 25 participants. The study started on 1997-06. Estimated completion is 2008-06.
What interventions are being tested in trial NCT00001656?
The interventions under investigation include: Olanzapine (DRUG), Clozapine (DRUG).
Who is sponsoring clinical trial NCT00001656?
This trial is sponsored by National Institute of Mental Health (NIMH), which has 343 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00001656's enrollment target sits among peer trials
25 1669th of 2000 higher than 302 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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