Comparative Effects of Chronic Treatment With Olanzapine and Risperidone on Glucose and Lipid Metabolism

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by:
Nathan Kline Institute for Psychiatric Research
ClinicalTrials.gov Identifier:
NCT00287820
First received: February 6, 2006
Last updated: July 22, 2011
Last verified: December 2007
  Purpose

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.


Condition Intervention Phase
Schizophrenia
Diabetes
Metabolic Syndrome
Hyperglycemia
Drug: Olanzapine
Drug: olanzapine
Drug: risperidone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Independent Investigator Grant Study-Comparative Effects of Chronic Treatment With Olanzapine and Risperidone on Glucose and Lipid Metabolism

Resource links provided by NLM:


Further study details as provided by Nathan Kline Institute for Psychiatric Research:

Primary Outcome Measures:
  • Serum glucose [ Time Frame: during 5 months of treatment compared to baseline ] [ Designated as safety issue: Yes ]
  • Hb1AC [ Time Frame: during 5 months of treatment compared to baseline ] [ Designated as safety issue: Yes ]
  • triglycerides [ Time Frame: during 5 months of treatment compared to baseline ] [ Designated as safety issue: Yes ]
  • cholesterol [ Time Frame: during 5 months of treatment compared to baseline ] [ Designated as safety issue: Yes ]
  • insulin [ Time Frame: during 5 months of treatment compared to baseline ] [ Designated as safety issue: Yes ]
  • c-peptide [ Time Frame: during 5 months of treatment compared to baseline ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • ghrelin [ Time Frame: during 5 months of treatment compared to baseline ] [ Designated as safety issue: No ]
  • CRP [ Time Frame: during 5 months of treatment compared to baseline ] [ Designated as safety issue: Yes ]
  • Thyroid hormones [ Time Frame: during 5 months of treatment compared to baseline ] [ Designated as safety issue: No ]
  • prolactin [ Time Frame: during 5 months of treatment compared to baseline ]
  • Il-6 [ Time Frame: during 5 months treatment compared to baseline ] [ Designated as safety issue: No ]
  • PANSS scores [ Time Frame: during 5 months of treatment compared to baseline ] [ Designated as safety issue: No ]
  • CGI score [ Time Frame: during 5 months of treatment compared to baseline ]
  • EPS scores [ Time Frame: during 5 months of treatment compared to baseline ] [ Designated as safety issue: Yes ]
  • TD Scores [ Time Frame: during 5 months of treatment compared to baseline ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 46
Study Start Date: February 2004
Study Completion Date: September 2007
Arms Assigned Interventions
Active Comparator: 1
olanzapine
Drug: Olanzapine
olanzapine 5-40 mg/day
Other Name: ayprexa
Drug: olanzapine
olanzapine 5-40 ,mg/day
Other Name: zyprexa
Active Comparator: 2
risperidone
Drug: risperidone
risperidone 1-12 mg/day
Other Name: riperidal

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Currently being treated with oral antidiabetics or insulin
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00287820

Locations
United States, New York
Manhattan Psychaitric Center
New York, New York, United States, 10035
Sponsors and Collaborators
Nathan Kline Institute for Psychiatric Research
Eli Lilly and Company
Investigators
Principal Investigator: Robert C Smith, MD PhD NYU Medical School, Dept of Psychiatry and Manhattan Psychiatric Center
  More Information

No publications provided by Nathan Kline Institute for Psychiatric Research

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Robert C. Smith MD, Manhatan Psychiatric Center
ClinicalTrials.gov Identifier: NCT00287820     History of Changes
Other Study ID Numbers: FiD-MC-x226(7524)
Study First Received: February 6, 2006
Last Updated: July 22, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Nathan Kline Institute for Psychiatric Research:
schizophrenia
diabetes
metabolic syndrome
hyperglycemia
glucose
insulin
lipids
IL-6
prolactin

Additional relevant MeSH terms:
Metabolic Syndrome X
Hyperglycemia
Schizophrenia
Syndrome
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Disease
Pathologic Processes
Risperidone
Olanzapine
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Antiemetics
Autonomic Agents

ClinicalTrials.gov processed this record on September 16, 2014