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Completed

NCT Number: NCT00287820

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 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.

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Key information

Conditions

Schizophrenia Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hyperglycemia Hyperinsulinism Insulin Resistance Mental Disorders Metabolic Diseases Metabolic Syndrome Nutritional and Metabolic Diseases Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Manhattan Psychaitric Center

New York, 10035, United States

About this study

In the on-going study in progress we use an extensive battery of assessments to investigate a)fasting levels of glucose and lipids at baseline and monthly during 5 months of treatment, b) glucose tolerance tests to investigate glucose and insulin abnormalities after a glucose load at baseline and during study treatment, and c)the effects of treatment with olanzapine and risperidone of post prandial glucose metabolism after a fatty meal (as detailed in the body of the proposal). Recent studies have shown that increased postprandial lipidemia is an important feature of many patients with type 2 diabetes and atherosclerosis. In addition to the biochemical measures, we will also assess clinical effects (PANSS and CGI ratings) and other side-effects (weight gain, appetite, somnolence, and EPS and TD). The specific plan calls for inpatients in a tertiary care hospital to be randomly assigned to olanzapine or risperidone, using a stratified random assignment procedure, and treated for five months with either olanzapine or risperidone. We estimate that we will have to enroll a sample of approximately 50-55 patients to obtain 46 acceptable complete cases(as specified in proposal below). On the basis of preliminary results from our prior and ongoing studies we predict no significant increase in glucose abnormalities from baseline during chronic treatment with olanzapine and no significant differences in development of glucose abnormalities in patients in patient treated with olanzapine and risperidone.

Additional measures being investigated include: comparison of olanzapine and risperidone in glucose and lipid responses to a fatty meal, ghrelin changes in response to a fatty mean, and CRP and IL-6, and thyroid and prolactin response to five months of treatment with the two drugs.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis
  • Schizophrenia or schizoaffective psychosis
  • 18-65 years of age

Exclusion criteria

  • Currently being treated with oral antidiabetics or insulin

Treatment and study plan

Olanzapine

Drug

olanzapine 5-40 mg/day

Other names: ayprexa

Risperidone

Drug

risperidone 1-12 mg/day

Other names: riperidal

Primary outcomes

  1. Serum glucose

    Time frame: during 5 months of treatment compared to baseline

  2. Hb1AC

    Time frame: during 5 months of treatment compared to baseline

  3. triglycerides

    Time frame: during 5 months of treatment compared to baseline

  4. cholesterol

    Time frame: during 5 months of treatment compared to baseline

  5. insulin

    Time frame: during 5 months of treatment compared to baseline

  6. c-peptide

    Time frame: during 5 months of treatment compared to baseline

Secondary outcomes

  1. ghrelin

    Time frame: during 5 months of treatment compared to baseline

  2. CRP

    Time frame: during 5 months of treatment compared to baseline

  3. Thyroid hormones

    Time frame: during 5 months of treatment compared to baseline

  4. prolactin

    Time frame: during 5 months of treatment compared to baseline

  5. Il-6

    Time frame: during 5 months treatment compared to baseline

  6. PANSS scores

    Time frame: during 5 months of treatment compared to baseline

  7. CGI score

    Time frame: during 5 months of treatment compared to baseline

  8. EPS scores

    Time frame: during 5 months of treatment compared to baseline

  9. TD Scores

    Time frame: during 5 months of treatment compared to baseline

Sponsors and collaborators

Lead sponsor

Nathan Kline Institute for Psychiatric Research

Other

Collaborators

  • Eli Lilly and Company

Registry information

Official study title

Independent Investigator Grant Study-Comparative Effects of Chronic Treatment With Olanzapine and Risperidone on Glucose and Lipid Metabolism

Important dates

Study start
2004
Study completion
2007
First posted
Feb 7, 2006
Registry last updated
Jul 25, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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