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

This study has been completed.
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014