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

Condition(s) targeted: Schizophrenia

Intervention: Olanzapine (Drug); Aripiprazole (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Eli Lilly and Company

Official(s) and/or principal investigator(s):
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), Study Director, Affiliation: 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.

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

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

Primary outcome:

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:

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.

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

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

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 00926, 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, St Charles, Missouri 63301, 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 44122, 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 44708, 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 38117, United States

Lilly Clinical Trial Registry

Starting date: July 2004
Last updated: November 5, 2007