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NCT00552500 · ClinicalTrials.gov registry record · NA
Effects of Atypical Antipsychotic and Valproate Combination Therapy on Glucose and Lipid Metabolism in Schizophrenia
A NA study of Insulin Resistance and Body Composition, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- NA
- Development phase
- 120
- Enrollment target
- 1
- Study location
NCT00552500 is a NA study of Insulin Resistance and Body Composition that has completed, run by Washington University School of Medicine. The registered enrollment target is 120 participants, below the 244-participant average among 120 other Insulin Resistance trials with a reported enrollment target (51% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00552500, a NA study of Insulin Resistance and Body Composition, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- NA
- Development phase
- 120 participants
- Enrollment target
- 1
- Study location
Study Summary
This project aims to a) evaluate the effects of haloperidol, olanzapine, and risperidone in combination with valproate on insulin secretion and insulin actions, b) evaluate medication effects on abdominal fat, total body fat and total fat-free mass, and c) evaluate treatment effects on glucose tolerance, lipid profiles, and plasma levels of leptin, adiponectin, ghrelin and C-reactive protein. Hypotheses will be evaluated by measuring 1) insulin action and secretion using frequently sampled intravenous glucose tolerance tests, 2) body composition using dual energy x-ray absorptiometry, magnetic resonance scans, and anthropomorphic measurements, and 3) changes in hormone levels and lipid profiles. The aims will be addressed in non-diabetic schizophrenia patients chronically treated with haloperidol, olanzapine or risperidone who will have valproate added to their treatment. Relevant data is critically needed to target basic research, identify long-term cardiovascular risks, and plan therapeutic interventions.
Conditions Studied
Interventions
- DRUG Depakote (valproate)
Study Locations (1)
Missouri
- Washington University School of Medicine - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2003-02 |
| Est. Completion | 2005-12 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00552500
The ClinicalTrials.gov registry entry for NCT00552500 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 244-participant average among 120 other Insulin Resistance trials with a reported enrollment target (51% lower). The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Insulin Resistance appearing as the primary indexed condition, and to 1 intervention - of which Depakote (valproate) is the first listed.
NCT00552500 reports 1 study location spanning 1 distinct geographic area - top geographies include Missouri.
Frequently Asked Questions
What is clinical trial NCT00552500 about?
NCT00552500 is a clinical study titled "Effects of Atypical Antipsychotic and Valproate Combination Therapy on Glucose and Lipid Metabolism in Schizophrenia". This project aims to a) evaluate the effects of haloperidol, olanzapine, and risperidone in combination with valproate on insulin secretion and insulin actions, b) evaluate medication effects on abdominal fat, total body fat and total fat-free mass, and c) evaluate treatment effects on glucose toler...
What is the current status of trial NCT00552500?
This trial is currently completed. It is a NA study. The enrollment target is 120 participants. The study started on 2003-02. Estimated completion is 2005-12.
What conditions does trial NCT00552500 study?
This clinical trial studies the following conditions: Insulin Resistance, Body Composition.
What interventions are being tested in trial NCT00552500?
The interventions under investigation include: Depakote (valproate) (DRUG).
Who is sponsoring clinical trial NCT00552500?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00552500 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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