- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00103571
Olanzapine Versus Aripiprazole in the Treatment of Acutely Ill Patients With Schizophrenia
November 5, 2007 updated by: Eli Lilly and Company
The purposes of this study are to assess similarities and differences in the efficacy (how well the drug works), safety, and side effects of olanzapine and aripiprazole in patients with schizophrenia, schizoaffective disorder, or schizophreniform disorder.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
600
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Rio Piedras, Puerto Rico, 00926
- 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. test
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Missouri
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St Charles, Missouri, United States, 63301
- 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. test
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Ohio
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Beachwood, Ohio, United States, 44122
- 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. test
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Canton, Ohio, United States, 44708
- 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. test
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Tennessee
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Memphis, Tennessee, United States, 38117
- 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. test
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients must have schizophrenia, schizoaffective disorder, or schizophreniform disorder
- Patients must be agitated
- Patients must display psychotic symptoms
- Patients must be inpatients who are expected to stay in the hospital for at least 5 days
- Patients must be 18 to 55 years of age
Exclusion Criteria:
- Patients may not be hospitalized for greater than 72 hours prior to study start
- Patients may not have received more than one dose of olanzapine or aripiprazole within 72 hours prior to study start
- Patients may not be actively suicidal
- Patients may not be diagnosed with substance-induced psychosis or substance dependence
- Patients may not have acute, serious, or unstable medical conditions
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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The primary objective of this study is to test the hypothesis that olanzapine is superior to aripiprazole in the reduction of symptoms of agitation in acutely ill patients with schizophrenia, as measured by mean change in the
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Positive and Negative Syndrome Scale Excited Component (PANSS-EC) over 5 days of treatment (4 continuous 24 hr treatment exposures). The null hypothesis of the study is that there is no difference between olanzapine and
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aripiprazole in reducing agitation.
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Secondary Outcome Measures
Outcome Measure |
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The reduction in positive symptoms as measured by the Brief Psychiatric Rating Scale Positive subscale (PBRS Positive);
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The reduction of symptoms of agitation as measured by Overt Agitation Severity Scale (OASS);
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The proportion of patients responding to treatment and the time to response based on varying levels in the percent reduction of
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the PANSS_EC from baseline;
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The reduction in overall severity of psychiatric illness as measured by the Clinical Global Impression-Severity Scale (CGI-S);
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The intensity of nursing intervention (e.g. seclusion, restraint, special nursing watch), as measured by the Global Assessment
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of Nursing Intervention
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The proportion of patients using pm lorazepam and the time-course of usage.
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The proportion of patients discontinuing from the study due to lack of efficacy or due to adverse events related to worsening
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of psychiatric illness.
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Patient satisfaction with their medication, as measured by Drug Attitude Inventory (DA1-10).
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A sensitivity analysis will be performed on two randomly chosen subsamples of the overall patient population by analyzing the
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primary objective respectively.
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Additional secondary objectives of the study are to compare the safety of olanzapine versus aripiprazole over the course of 5
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days in the treatment of acutely ill patients with schizophrenia as assessed by:
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Relative degree of sedation as measured by the Agitation Calmness Evalution Scale (ACES);
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Review of spontaneous (unsolicited) treatment emergent adverse events;
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Development of extrapyramidal symptoms as assessed by daily Modified Simpson-Angus and Barnes Akathisia scale scores.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Call 1-877-CTLILLY(1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2004
Primary Completion
December 6, 2022
Study Completion (Actual)
August 1, 2006
Study Registration Dates
First Submitted
February 10, 2005
First Submitted That Met QC Criteria
February 10, 2005
First Posted (Estimate)
February 11, 2005
Study Record Updates
Last Update Posted (Estimate)
November 6, 2007
Last Update Submitted That Met QC Criteria
November 5, 2007
Last Verified
November 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Schizophrenia Spectrum and Other Psychotic Disorders
- Schizophrenia
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Antiemetics
- Gastrointestinal Agents
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Uptake Inhibitors
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Antidepressive Agents
- Dopamine Agonists
- Dopamine Agents
- Serotonin 5-HT1 Receptor Agonists
- Serotonin Receptor Agonists
- Serotonin 5-HT2 Receptor Antagonists
- Serotonin Antagonists
- Dopamine D2 Receptor Antagonists
- Dopamine Antagonists
- Olanzapine
- Aripiprazole
Other Study ID Numbers
- 8928
- F1D-US-HGLS
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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