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

NCT ID: NCT00287820

Last Updated: 2011-07-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-02-29
• Study Completion Date: 2007-09-30

Brief 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.

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.

Conditions

Schizophrenia; Diabetes; Metabolic Syndrome; Hyperglycemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

olanzapine

Group Type: ACTIVE_COMPARATOR

Olanzapine

Intervention Type: DRUG

olanzapine 5-40 mg/day

olanzapine

Intervention Type: DRUG

olanzapine 5-40 ,mg/day

2

risperidone

Group Type: ACTIVE_COMPARATOR

risperidone

Intervention Type: DRUG

risperidone 1-12 mg/day

Interventions

Olanzapine

olanzapine 5-40 mg/day

Intervention Type: DRUG

olanzapine

olanzapine 5-40 ,mg/day

Intervention Type: DRUG

risperidone

risperidone 1-12 mg/day

Intervention Type: DRUG

Other Intervention Names

ayprexa; zyprexa; riperidal

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Currently being treated with oral antidiabetics or insulin

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: collaborator

Nathan Kline Institute for Psychiatric Research

OTHER

Sponsor Role: lead

Responsible Party

Manhatan Psychiatric Center

Principal Investigators

Robert C Smith, MD PhD

Role: PRINCIPAL_INVESTIGATOR

NYU Medical School, Dept of Psychiatry and Manhattan Psychiatric Center

Locations

Manhattan Psychaitric Center

New York, New York, United States

Countries

United States

References

Smith RC, Rachakonda S, Dwivedi S, Davis JM. Olanzapine and risperidone effects on appetite and ghrelin in chronic schizophrenic patients. Psychiatry Res. 2012 Oct 30;199(3):159-63. doi: 10.1016/j.psychres.2012.03.011. Epub 2012 Apr 3.

Reference Type: DERIVED

PMID: 22475524 (View on PubMed)

Smith RC, Lindenmayer JP, Hu Q, Kelly E, Viviano TF, Cornwell J, Vaidhyanathaswamy S, Marcovina S, Davis JM. Effects of olanzapine and risperidone on lipid metabolism in chronic schizophrenic patients with long-term antipsychotic treatment: a randomized five month study. Schizophr Res. 2010 Jul;120(1-3):204-9. doi: 10.1016/j.schres.2010.04.001. Epub 2010 May 10.

Reference Type: DERIVED

PMID: 20457512 (View on PubMed)

Smith RC, Lindenmayer JP, Davis JM, Kelly E, Viviano TF, Cornwell J, Hu Q, Khan A, Vaidhyanathaswamy S. Effects of olanzapine and risperidone on glucose metabolism and insulin sensitivity in chronic schizophrenic patients with long-term antipsychotic treatment: a randomized 5-month study. J Clin Psychiatry. 2009 Nov;70(11):1501-13. doi: 10.4088/JCP.08m04446yel. Epub 2009 Oct 6.

Reference Type: DERIVED

PMID: 19814947 (View on PubMed)

Other Identifiers

FiD-MC-x226(7524)

Identifier Type: -

Identifier Source: org_study_id