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NCT00287820 · ClinicalTrials.gov registry record · Phase 4
Comparative Effects of Chronic Treatment With Olanzapine and Risperidone on Glucose and Lipid Metabolism
A Phase 4 study of Diabetes and Schizophrenia, sponsored by Nathan Kline Institute for Psychiatric Research.
- Completed
- Registry status
- Phase 4
- Development phase
- 46
- Enrollment target
- 1
- Study location
NCT00287820 is a Phase 4 study of Diabetes and Schizophrenia that has completed, run by Nathan Kline Institute for Psychiatric Research. The registered enrollment target is 46 participants, below the 3,028-participant average among 338 other Diabetes trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00287820, a Phase 4 study of Diabetes and Schizophrenia, has completed, sponsored by Nathan Kline Institute for Psychiatric Research.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 46 participants
- Enrollment target
- 1
- Study location
Study Summary
The primary objective of the study is to assess whether chronic treatment with olanzapine over a five-month period produces a significant increase in abnormalities in glucose levels. The main secondary objective is to evaluate whether the increase in glucose levels and rate of glucose abnormalities differs between Olanzapine and Risperidone during this treatment period. Additional secondary objectives of the study are to investigate similar questions with respect to glycohemoglobin, triglycerides and other measures of glucose and lipid metabolism. We hypothesize that Olanzapine will not be inferior to Risperidone in extent of increase in the primary outcome measure of serum glucose, and secondary measures of glycohemoglobin, insulin and lipids.
Conditions Studied
Interventions
- DRUG Olanzapine
- DRUG risperidone
- DRUG olanzapine
Study Locations (1)
New York
- Manhattan Psychaitric Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2004-02 |
| Est. Completion | 2007-09 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00287820
The ClinicalTrials.gov registry entry for NCT00287820 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 46 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,028-participant average among 338 other Diabetes trials with a reported enrollment target (98% lower). The listed sponsor is Nathan Kline Institute for Psychiatric Research, which has 20 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Diabetes appearing as the primary indexed condition, and to 3 interventions - of which Olanzapine is the first listed.
NCT00287820 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT00287820 about?
NCT00287820 is a clinical study titled "Comparative Effects of Chronic Treatment With Olanzapine and Risperidone on Glucose and Lipid Metabolism". The primary objective of the study is to assess whether chronic treatment with olanzapine over a five-month period produces a significant increase in abnormalities in glucose levels. The main secondary objective is to evaluate whether the increase in glucose levels and rate of glucose abnormalities ...
What is the current status of trial NCT00287820?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 46 participants. The study started on 2004-02. Estimated completion is 2007-09.
What conditions does trial NCT00287820 study?
This clinical trial studies the following conditions: Diabetes, Schizophrenia, Metabolic Syndrome, Hyperglycemia.
What interventions are being tested in trial NCT00287820?
The interventions under investigation include: Olanzapine (DRUG), risperidone (DRUG), olanzapine (DRUG).
Who is sponsoring clinical trial NCT00287820?
This trial is sponsored by Nathan Kline Institute for Psychiatric Research, which has 20 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00287820 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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