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NCT00205699 · ClinicalTrials.gov registry record · Phase 4
Metabolic Effects of Antipsychotics in Children
A Phase 4 study, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- Phase 4
- Development phase
- 144
- Enrollment target
NCT00205699: Completed Phase 4 study, sponsored by Washington University School of Medicine.
NCT00205699 is a Phase 4 study that has completed, run by Washington University School of Medicine. The registered enrollment target is 144 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00205699, a Phase 4 study, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 144 participants
- Enrollment target
Study Summary
The project aims to describe and compare the outcome of 12 weeks of prospective, randomized treatment with olanzapine, risperidone or aripiprazole on insulin action in skeletal muscle, liver and adipose tissue, abdominal fat mass, total body and fat-free mass, efficacy for symptoms of aggression and non-metabolic adverse events. Children aged 6-18 will be studied, exploring effects of stimulant therapy and age-related differences in vulnerability to treatment-induced adverse metabolic changes. Aims are addressed by measuring glucose and lipid kinetics with stable isotope tracers, body composition with dual energy x-ray absorptiometry and magnetic resonance imaging (MRI), and standardized assessments of efficacy and adverse events. Relevant data are critically needed to target clinical therapy and basic research, identify medical risks, and guide regulatory decisions in this vulnerable population.
Primary Outcome
This study hypothesized that antipsychotic treatment would increase percent total body fat, as measured by whole body dual energy x-ray absorptiometry (DEXA), with larger adverse effects for olanzapine.
Interventions
- DRUG risperidone
- DRUG olanzapine
- DRUG aripiprazole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 144 participants |
| Start Date | 2006-04 |
| Est. Completion | 2011-07 |
| Phase | Phase 4 |
What the finished NCT00205699 record still lists
NCT00205699 is an interventional study that assigns participants to a tested intervention. The registered 144 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 (72% lower).
The record links to 0 conditions, and to 3 interventions - of which risperidone is the first listed.
NCT00205699 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00205699 about?
NCT00205699 is a clinical study titled "Metabolic Effects of Antipsychotics in Children". The project aims to describe and compare the outcome of 12 weeks of prospective, randomized treatment with olanzapine, risperidone or aripiprazole on insulin action in skeletal muscle, liver and adipose tissue, abdominal fat mass, total body and fat-free mass, efficacy for symptoms of aggression and...
What is the current status of trial NCT00205699?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 144 participants. The study started on 2006-04. Estimated completion is 2011-07.
What interventions are being tested in trial NCT00205699?
The interventions under investigation include: risperidone (DRUG), olanzapine (DRUG), aripiprazole (DRUG).
Who is sponsoring clinical trial NCT00205699?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00205699's enrollment target sits among peer trials
144 577th of 2000 higher than 1,421 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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