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Safety Study of Olanzapine and a Comparator in Patients With Schizophrenia and Schizoaffective Disorder
This study has been completed.
Sponsored by: Eli Lilly and Company
Information provided by: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00190749
  Purpose

This study will assess whether olanzapine and/or risperidone affect the way the human body uses sugar in the blood.


Condition Intervention Phase
Schizophrenia
Schizoaffective Disorder
 Drug: olanzapine
Drug: risperidone
 Phase IV

MedlinePlus related topics: Schizophrenia
Drug Information available for: Insulin Risperidone Olanzapine
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety Study
Official Title: Insulin Sensitivity in Patients With Schizophrenia or Schizoaffective Disorder Treated With Olanzapine and Risperidone

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Assess if olanzapine and risperidone are associated with a significant within-treatment group change in insulin sensitivity as measured by hyperinsulinemic euglycemic clamp. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Comparison of effects of olanzapine vs. risperidone on the change in normalized insulin sensitivity index at low insulin phase from baseline to endpoint, after correcting for weight change. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Evaluation for each treatment group of the relationships between change in normalized insulin sensitivity index at low insulin phase and changes in weight. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Evaluation for each treatment group of the relationships between change in normalized insulin sensitivity index at low insulin phase and changes in Body Mass Index. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Evaluation for each treatment group of the relationships between change in normalized insulin sensitivity index at low insulin phase and changes in ratio of visceral fat area to the subcutaneous fat area. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Evaluation for each treatment group of the relationships between change in normalized insulin sensitivity index at low insulin phase and changes in Brief Psychiatric Rating Scale scores. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Evaluation for each treatment group of the relationships between change in normalized insulin sensitivity index at low insulin phase and changes in Clinical Global Impression - Severity of Illness scale scores. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Evaluation for each treatment group of the relationships between change in normalized insulin sensitivity index at low insulin phase and changes in Abnormal Involuntary Movement Scale scores. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Evaluation for each treatment group of the relationships between change in normalized insulin sensitivity index at low insulin phase and changes in Barnes Akathisia Scale scores. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Evaluation for each treatment group of the relationships between change in normalized insulin sensitivity index at low insulin phase and changes in the Simpson Angus Scale scores. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Evaluation for each treatment group of the relationships between change in normalized insulin sensitivity index at low insulin phase and changes in waist circumference. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Evaluation for each treatment group of the relationships between change in normalized insulin sensitivity index at low insulin phase and changes in visceral fat area. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Evaluation for each treatment group of the relationships between change in normalized insulin sensitivity index at low insulin phase and changes in subcutaneous fat area. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Evaluation for each treatment group of the relationships between change in normalized insulin sensitivity index at low insulin phase and changes in Eating Behavior Assessment Scale scores. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Evaluation of both the within-treatment group and between-treatment group changes from baseline to endpoint in Body Mass Index. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Evaluation of both the within-treatment group and between-treatment group changes from baseline to endpoint in weight. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Evaluation of both the within-treatment group and between-treatment group changes from baseline to endpoint in waist circumference. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Evaluation of both the within-treatment group and between-treatment group changes from baseline to endpoint in visceral fat area. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Evaluation of both the within-treatment group and between-treatment group changes from baseline to endpoint in subcutaneous fat area. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Evaluation of both the within-treatment group and between-treatment group changes from baseline to endpoint in the ratio of the visceral fat area to the subcutaneous fat area. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Evaluation of both the within-treatment group and between-treatment group changes from baseline to endpoint in Brief Psychiatric Rating Scale scores. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Evaluation of both the within-treatment group and between-treatment group changes from baseline to endpoint in Clinical Global Impression - Severity of Illness scores. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Evaluation of both the within-treatment group and between-treatment group changes from baseline to endpoint in Abnormal Involuntary Movement Scale scores. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Evaluation of both the within-treatment group and between-treatment group changes from baseline to endpoint in Barnes Akathisia Scale scores. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Evaluation of both the within-treatment group and between-treatment group changes from baseline to endpoint in Simpson Angus Scale scores. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Evaluation of both the within-treatment group and between-treatment group changes from baseline to endpoint in Eating Behavior Assessment Scale scores. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Evaluation of both the within-treatment group and between-treatment group changes in fasting lipid parameters including total cholesterol. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Evaluation of both the within-treatment group and between-treatment group changes in fasting lipid parameters including direct LDL. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Evaluation of both the within-treatment group and between-treatment group changes in fasting lipid parameters including HDL. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Evaluation of both the within-treatment group and between-treatment group changes in fasting lipid parameters including triglycerides. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Evaluation of both the within-treatment group and between-treatment group changes in fasting lipid parameters including lipoprotein subclasses. [ Time Frame: 12 weeks. ] [ Designated as safety issue: Yes ]

Enrollment: 132
Study Start Date: October 2003
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Experimental Drug: olanzapine
5-20mg, oral, capsules, daily, 12 weeks.
B: Active Comparator Drug: risperidone
2-6mg, oral, capsules, BID, 12 weeks.

  Eligibility

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

Inclusion Criteria:

  • 18-65 years old
  • Diagnosed with Schizophrenia or Schizoaffective disorder
  • Ability to visit the Dr's office for scheduled visits

Exclusion Criteria:

  • Women who are pregnant or breastfeeding
  • Have a BMI greater than 40
  • Have diabetes, heart disease or any other unstable illness
  • Have known positive HIV
  • Are currently taking olanzapine, risperidone, clozapine, glucocorticoids, injectable antipsychotics
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00190749

Locations
United States, California
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
San Diego, California, United States, 92161
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

Lilly Clinical Trial Registry  This link exits the ClinicalTrials.gov site

Responsible Party: Eli Lilly ( Chief Medical Officer )
Study ID Numbers: 5296, F1D-MC-S014
Study First Received: September 12, 2005
Last Updated: September 24, 2008
ClinicalTrials.gov Identifier: NCT00190749  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Schizophrenia
Dopamine
Mental Disorders
Risperidone
Olanzapine
 Psychotic Disorders
Serotonin
Insulin
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Disease
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Gastrointestinal Agents
Psychotropic Drugs
Antiemetics
Central Nervous System Depressants
Dopamine Antagonists
 Antipsychotic Agents
Serotonin Uptake Inhibitors
Pharmacologic Actions
Serotonin Antagonists
Pathologic Processes
Serotonin Agents
Autonomic Agents
Therapeutic Uses
Dopamine Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009



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