Olanzapine Versus Aripiprazole in the Treatment of Acutely Ill Patients With Schizophrenia
This study has been completed.
Sponsor:
Eli Lilly and Company
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00103571
First received: February 10, 2005
Last updated: November 5, 2007
Last verified: November 2007
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Schizophrenia |
Drug: Olanzapine Drug: Aripiprazole |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Olanzapine Versus Aripiprazole in the Treatment of Acutely Ill Patients With Schizophrenia |
Resource links provided by NLM:
Further study details as provided by Eli Lilly and Company:
Primary Outcome Measures:
- 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
- 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
- aripiprazole in reducing agitation.
Secondary Outcome Measures:
- The reduction in positive symptoms as measured by the Brief Psychiatric Rating Scale Positive subscale (PBRS Positive);
- The reduction of symptoms of agitation as measured by Overt Agitation Severity Scale (OASS);
- The proportion of patients responding to treatment and the time to response based on varying levels in the percent reduction of
- the PANSS_EC from baseline;
- The reduction in overall severity of psychiatric illness as measured by the Clinical Global Impression-Severity Scale (CGI-S);
- The intensity of nursing intervention (e.g. seclusion, restraint, special nursing watch), as measured by the Global Assessment
- of Nursing Intervention
- The proportion of patients using pm lorazepam and the time-course of usage.
- The proportion of patients discontinuing from the study due to lack of efficacy or due to adverse events related to worsening
- of psychiatric illness.
- Patient satisfaction with their medication, as measured by Drug Attitude Inventory (DA1-10).
- A sensitivity analysis will be performed on two randomly chosen subsamples of the overall patient population by analyzing the
- primary objective respectively.
- Additional secondary objectives of the study are to compare the safety of olanzapine versus aripiprazole over the course of 5
- days in the treatment of acutely ill patients with schizophrenia as assessed by:
- Relative degree of sedation as measured by the Agitation Calmness Evalution Scale (ACES);
- Review of spontaneous (unsolicited) treatment emergent adverse events;
- Development of extrapyramidal symptoms as assessed by daily Modified Simpson-Angus and Barnes Akathisia scale scores.
| Estimated Enrollment: | 600 |
| Study Start Date: | July 2004 |
| Study Completion Date: | August 2006 |
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00103571
Locations
| United States, Missouri | |
| 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 | |
| St Charles, Missouri, United States, 63301 | |
| United States, Ohio | |
| 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 | |
| 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 | |
| Canton, Ohio, United States, 44708 | |
| United States, Tennessee | |
| 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 | |
| Memphis, Tennessee, United States, 38117 | |
| Puerto Rico | |
| 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 | |
| Rio Piedras, Puerto Rico, 00926 | |
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 - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00103571 History of Changes |
| Other Study ID Numbers: | 8928, F1D-US-HGLS |
| Study First Received: | February 10, 2005 |
| Last Updated: | November 5, 2007 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Schizophrenia Schizophrenia and Disorders with Psychotic Features Mental Disorders Olanzapine Aripiprazole Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents |
Therapeutic Uses Psychotropic Drugs Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Serotonin Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Gastrointestinal Agents |
ClinicalTrials.gov processed this record on May 19, 2013