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NCT00053703 · ClinicalTrials.gov registry record · Phase 4
Treatment of Early Onset Schizophrenia Spectrum Disorders (TEOSS)
A Phase 4 study, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- Phase 4
- Development phase
- 116
- Enrollment target
NCT00053703: Completed Phase 4 study, sponsored by University of North Carolina, Chapel Hill.
NCT00053703 is a Phase 4 study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 116 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00053703, a Phase 4 study, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 116 participants
- Enrollment target
Study Summary
This study will evaluate the safety and efficacy of risperidone (Risperdal®), olanzapine (Zyprexa®), and molindone (Moban®) for the treatment of children and adolescents with schizophrenia or schizoaffective disorder.
Primary Outcome
Assessed with the Positive and Negative Syndrome Scale in which a clinician rates various psychotic symptoms on the basis of observation of the participant, interview with the participant, and review of all other available information including informant reports. The scale consists of 30 items which are rated categorically between 1 - no symptoms to 7 - extreme symptoms. The minimal score is 0 and the maximal score is 210, with higher scores reflecting more symptoms. Typically scores \> that 60
Interventions
- DRUG Risperidone
- DRUG Molindone
- DRUG Olanzapine (enrollment closed in this treatment)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 116 participants |
| Start Date | 2002-02 |
| Est. Completion | 2007-05 |
| Phase | Phase 4 |
What the finished NCT00053703 record still lists
NCT00053703 is an interventional study that assigns participants to a tested intervention. The registered 116 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 3 interventions - of which Risperidone is the first listed.
NCT00053703 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00053703 about?
NCT00053703 is a clinical study titled "Treatment of Early Onset Schizophrenia Spectrum Disorders (TEOSS)". This study will evaluate the safety and efficacy of risperidone (Risperdal®), olanzapine (Zyprexa®), and molindone (Moban®) for the treatment of children and adolescents with schizophrenia or schizoaffective disorder.
What is the current status of trial NCT00053703?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 116 participants. The study started on 2002-02. Estimated completion is 2007-05.
What interventions are being tested in trial NCT00053703?
The interventions under investigation include: Risperidone (DRUG), Molindone (DRUG), Olanzapine (enrollment closed in this treatment) (DRUG).
Who is sponsoring clinical trial NCT00053703?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00053703's enrollment target sits among peer trials
116 714th of 2000 higher than 1,283 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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