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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 is a Phase 4 study that has completed, run by Washington University School of Medicine. The registered enrollment target is 144 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00205699
The ClinicalTrials.gov registry entry for NCT00205699 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 144 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which risperidone is the first listed.
NCT00205699 reports 0 study locations.
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.
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