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Olanzapine Versus Aripiprazole in the Treatment of Acutely Ill Patients With Schizophrenia

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Olanzapine
Aripiprazole
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • 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
  • 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
  • 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
  • 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
  • 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

Outcomes

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.

Full Information

First Posted
February 10, 2005
Last Updated
November 5, 2007
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT00103571
Brief Title
Olanzapine Versus Aripiprazole in the Treatment of Acutely Ill Patients With Schizophrenia
Official Title
Olanzapine Versus Aripiprazole in the Treatment of Acutely Ill Patients With Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
November 2007
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Eli Lilly and Company

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
600 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Olanzapine
Intervention Type
Drug
Intervention Name(s)
Aripiprazole
Primary Outcome Measure Information:
Title
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
Title
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
Title
aripiprazole in reducing agitation.
Secondary Outcome Measure Information:
Title
The reduction in positive symptoms as measured by the Brief Psychiatric Rating Scale Positive subscale (PBRS Positive);
Title
The reduction of symptoms of agitation as measured by Overt Agitation Severity Scale (OASS);
Title
The proportion of patients responding to treatment and the time to response based on varying levels in the percent reduction of
Title
the PANSS_EC from baseline;
Title
The reduction in overall severity of psychiatric illness as measured by the Clinical Global Impression-Severity Scale (CGI-S);
Title
The intensity of nursing intervention (e.g. seclusion, restraint, special nursing watch), as measured by the Global Assessment
Title
of Nursing Intervention
Title
The proportion of patients using pm lorazepam and the time-course of usage.
Title
The proportion of patients discontinuing from the study due to lack of efficacy or due to adverse events related to worsening
Title
of psychiatric illness.
Title
Patient satisfaction with their medication, as measured by Drug Attitude Inventory (DA1-10).
Title
A sensitivity analysis will be performed on two randomly chosen subsamples of the overall patient population by analyzing the
Title
primary objective respectively.
Title
Additional secondary objectives of the study are to compare the safety of olanzapine versus aripiprazole over the course of 5
Title
days in the treatment of acutely ill patients with schizophrenia as assessed by:
Title
Relative degree of sedation as measured by the Agitation Calmness Evalution Scale (ACES);
Title
Review of spontaneous (unsolicited) treatment emergent adverse events;
Title
Development of extrapyramidal symptoms as assessed by daily Modified Simpson-Angus and Barnes Akathisia scale scores.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
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
City
St Charles
State/Province
Missouri
ZIP/Postal Code
63301
Country
United States
Facility Name
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
City
Beachwood
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
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
City
Canton
State/Province
Ohio
ZIP/Postal Code
44708
Country
United States
Facility Name
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
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38117
Country
United States
Facility Name
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
City
Rio Piedras
ZIP/Postal Code
00926
Country
Puerto Rico

12. IPD Sharing Statement

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Olanzapine Versus Aripiprazole in the Treatment of Acutely Ill Patients With Schizophrenia

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