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Sponsored by: |
Eli Lilly and Company |
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Information provided by: | Eli Lilly and Company |
ClinicalTrials.gov Identifier: | NCT00190749 |
This study will assess whether olanzapine and/or risperidone affect the way the human body uses sugar in the blood.
Condition | Intervention | Phase |
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Schizophrenia Schizoaffective Disorder |
Drug: olanzapine Drug: risperidone |
Phase IV |
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 |
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 |
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A: Experimental |
Drug: olanzapine
5-20mg, oral, capsules, daily, 12 weeks.
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B: Active Comparator |
Drug: risperidone
2-6mg, oral, capsules, BID, 12 weeks.
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Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
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 |
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 |
Schizophrenia Dopamine Mental Disorders Risperidone Olanzapine |
Psychotic Disorders Serotonin Insulin Schizophrenia and Disorders with Psychotic Features |
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 |