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

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00103571
• Other study ID #: 8928
• Secondary ID: F1D-US-HGLS
• Status: Completed
• Phase: Phase 4
• First received: February 10, 2005
• Last updated: November 5, 2007
• Start date: July 2004
• Est. completion date: August 2006

Study information

• Verified date: November 2007
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Olanzapine

• Aripiprazole

Locations

Country	Name	City	State
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
United States	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	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	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	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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

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

External Links

•   Lilly Clinical Trial Registry