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

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00287820
• Other study ID #: FiD-MC-x226(7524)
• Status: Completed
• Phase: Phase 4
• First received: February 6, 2006
• Last updated: July 22, 2011
• Start date: February 2004
• Est. completion date: September 2007

Study information

• Verified date: December 2007
• Source: Nathan Kline Institute for Psychiatric Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Diagnosis

• Schizophrenia or schizoaffective psychosis

• 18-65 years of age

Exclusion Criteria:

• Currently being treated with oral antidiabetics or insulin

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Hyperglycemia
• Metabolic Syndrome
• Metabolic Syndrome X
• Schizophrenia

Intervention

Drug:
• Olanzapine
olanzapine 5-40 mg/day
• olanzapine
olanzapine 5-40 ,mg/day
• risperidone
risperidone 1-12 mg/day

Locations

Country	Name	City	State
United States	Manhattan Psychaitric Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Nathan Kline Institute for Psychiatric Research	Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum glucose		during 5 months of treatment compared to baseline	Yes
Primary	Hb1AC		during 5 months of treatment compared to baseline	Yes
Primary	triglycerides		during 5 months of treatment compared to baseline	Yes
Primary	cholesterol		during 5 months of treatment compared to baseline	Yes
Primary	insulin		during 5 months of treatment compared to baseline	Yes
Primary	c-peptide		during 5 months of treatment compared to baseline	Yes
Secondary	ghrelin		during 5 months of treatment compared to baseline	No
Secondary	CRP		during 5 months of treatment compared to baseline	Yes
Secondary	Thyroid hormones		during 5 months of treatment compared to baseline	No
Secondary	prolactin		during 5 months of treatment compared to baseline
Secondary	Il-6		during 5 months treatment compared to baseline	No
Secondary	PANSS scores		during 5 months of treatment compared to baseline	No
Secondary	CGI score		during 5 months of treatment compared to baseline
Secondary	EPS scores		during 5 months of treatment compared to baseline	Yes
Secondary	TD Scores		during 5 months of treatment compared to baseline	Yes