Safety Study of Olanzapine and a Comparator in Patients With Schizophrenia and Schizoaffective Disorder

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00190749
First received: September 12, 2005
Last updated: April 26, 2010
Last verified: April 2010
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Insulin Sensitivity in Patients With Schizophrenia or Schizoaffective Disorder Treated With Olanzapine and Risperidone

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Change in Baseline to Last Observation In Normalized Insulin Sensitivity Index at Low Insulin Phase Using Change in Weight as a Covariate [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: Yes ]
    Normalized insulin sensitivity index (Mffm/I) was defined as the ratio of whole body glucose disposal rate normalized to fat-free mass (Mffm) divided by the plasma insulin concentration (I) during steady-state conditions of the clamp procedure. Units:[(mg glucose)*min*mL] / [(kg fat free body mass)*(micro IU insulin)]


Secondary Outcome Measures:
  • Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Weight. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I and changes in weight

  • Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Body Mass Index (BMI) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I and changes in BMI

  • Pairwise Correlations Between Changes 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 ]
    Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in ratio of visceral far area to subcutaneous fat area

  • Pairwise Correlations Between Changes 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 ]
    Normalized insulin senstivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I and changes in Brief Psychiatric Rating Scale scores

  • Pairwise Correlations Between Changes 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 ]
    Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I and changes in Clinical Global Impression-Severity of Illness scale scores

  • Pairwise Correlations Between Changes 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 ]
    Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I and changes in Abnormal Involuntary Movement Scale scores

  • Pairwise Correlation Between Changes 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 ]
    Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I and changes in Barnes Akathisia scores

  • Pairwise Correlations Between Changes 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 ]
    Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in the Simpson Angus Scale scores

  • Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Waist Circumference. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I and changes in waist circumference

  • Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Visceral Fat Area. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I and changes in visceral fat area

  • Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Subcutaneous Fat Area. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I and changes in subcutaneous fat area

  • Pairwise Correlations Between Between Changes 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 ]
    Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I and changes in Eating Behavior Assessment Scale scores

  • Change From Baseline to 12 Week Endpoint in Body Mass Index [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: Yes ]
    Within-and Between-Treatment Group changes in Body Mass Index from baseline to last observation carried forward.

  • Change From Baseline to 12 Week Endpoint in Weight [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: Yes ]
    Weight change from baseline to last visit (last observation carried forward)

  • Change From Baseline to 12 Week Endpoint in Waist Circumference [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: Yes ]
    Waist circumference change from baseline to last observation carried forward.

  • Change From Baseline to 12 Week Endpoint in Visceral Fat Area [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: Yes ]
    Visceral fat area change from baseline to last observation carried forward, all randomized patients, double-blind treatment period

  • Change From Baseline to 12 Week Endpoint in Subcutaneous Fat Area [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: Yes ]
    Subcutaneous fat area change from baseline to last observation carried forward, all randomized patients, double-blind treatment period

  • Change From Baseline to 12 Week Endpoint in the Ratio of the Visceral Fat Area to the Subcutaneous Fat Area [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: Yes ]
    Ratio of the visceral fat area to the subcutaneous fat area change from baseline to last observation carried forward, all randomized patients, double-blind treatment period

  • Change From Baseline to 12 Week Endpoint in Brief Psychiatric Rating Scale (BPRS) Scores [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: No ]
    Brief Psychiatric Rating Scale (BPRS) is an 18-item clinician-administered scale used to assess the degree of severity of a subject's general psychopathological symptoms. Item scores range from 0 (not present) to 6 (extremely severe). Total Scores range from 0 to 108; Positive Subscale Scores range from 0 to 24. Negative Subscale Scores range from 0 to 18. Anxiety-Depression Subscale Scores range from 0 to 24.

  • Change From Baseline to 12 Week Endpoint in Clinical Global Impression - Severity of Illness Scores [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: No ]
    Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients.

  • Change From Baseline to 12 Week Endpoint in Abnormal Involuntary Movement Scale Scores [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: Yes ]
    A 12-item instrument assesses observed abnormal movements in different parts of body. Seven items are scored in a 5-point scale (0 = none/normal, 4 = severe) which evaluates abnormal movements in 3 main anatomic areas (orofacial area, extremities, and trunk). Total scores range from 0 to 28. Five collected elements are not used in this total.

  • Change From Baseline to 12 Week Endpoint in Barnes Akathisia Rating Scale (BARS) Scores [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: Yes ]
    The BARS is a 4-item instrument that evaluates akathisia associated with use of antipsychotic medications. Item 4 is the Global clinical assessment and is rated 0 to 5 (0 = absent, 5 = severe). The other 3 items (related to objective and subjective assessments) are not used for these analyses.

  • Change From Baseline to 12 Week Endpoint in Simpson Angus Scale Scores [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: Yes ]
    Measures neuroleptic-induced parkinsonism. Total score of Simpson Angus Scale consists of the sum of 10 items rated on a 5-point severity scale where 0=normal and 4=extreme. The total score ranges from 0 to 40.

  • Change From Baseline to 12 Week Endpoint in Eating Behavior Assessment Scale Scores [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: Yes ]
    Eating Behavior Assessment Scale is a 9-item self-rated tool used to evaluate appetite and eating behaviors. Item scores range from 0 (never) to 4 (always).

  • Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Total Cholesterol [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: Yes ]
    Fasting lipid parameters including total cholesterol, change from baseline to last observation carried forward.

  • Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Direct Low Density Lipoprotein (LDL) [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: Yes ]
    Fasting lipid parameters including Direct LDL, change from baseline to last observation carried forward.

  • Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including High Density Lipoprotein (HDL) [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: Yes ]
    Fasting lipid parameters including HDL change from baseline to last observation carried forward.

  • Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Triglycerides [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: Yes ]
    Changes in fasting lipid parameters including triglycerides last observation carried forward (LOCF) mean change from baseline

  • Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Lipoprotein Subclasses [ Time Frame: baseline and 12 weeks. ] [ Designated as safety issue: Yes ]
    Changes in lipid parameters and subclass lipoproteins last observation carried forward (LOCF) mean change from baseline. HDL=High Density Lipoprotein, IDL=Intermdiate Density Lipoprotein, LDL=Low Density Lipoprotein, VLDL=Very Low Density Lipoprotein.


Enrollment: 130
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
Experimental: Olanzapine Drug: olanzapine
5-20 mg, oral, capsules, daily, 12 weeks.
Other Names:
  • LY170053
  • Zyprexa
Active Comparator: Risperidone Drug: risperidone
2-6 mg, oral, capsules, twice daily (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 doctor's office for scheduled visits

Exclusion Criteria:

  • Women who are pregnant or breastfeeding
  • Have a body mass index (BMI) greater than 40
  • Have diabetes, heart disease or any other unstable illness
  • Have known positive human immunodeficiency virus (HIV)
  • Are currently taking olanzapine, risperidone, clozapine, glucocorticoids, injectable antipsychotics
  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: 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

Additional Information:
No publications provided by Eli Lilly and Company

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00190749     History of Changes
Other Study ID Numbers: 5296, F1D-MC-S014
Study First Received: September 12, 2005
Results First Received: June 3, 2009
Last Updated: April 26, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Schizophrenia
Disease
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
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
Peripheral Nervous System Agents
Gastrointestinal Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on October 02, 2014