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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: Completed NA study of Insulin Resistance and Body Composition, sponsored by Washington University School of Medicine.

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Interventions

  • DRUG Depakote (valproate)

Study Locations (1)

Missouri

  • Washington University School of Medicine - St Louis

Trial Details

FieldValue
Enrollment Target 120 participants
Start Date 2003-02
Est. Completion 2005-12
Phase NA

What the finished NCT00552500 record still lists

NCT00552500 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 244-participant average among 120 other Insulin Resistance trials with a reported enrollment target (51% lower).

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 a single indexed study location in 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.

Similar trials for Insulin Resistance

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00552500's enrollment target sits among peer trials

120 21st of 120 higher than 99 of 120 other Insulin Resistance trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Insulin Resistance 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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Source: ClinicalTrials.gov NCT00552500, the US trial registry maintained by the National Library of Medicine. NCT00552500 (mid enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.