Managing Acute Schizophrenia, a Comparison Between Two Atypical Antipsychotics - Full Text View

Sponsor:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00485498

Purpose

The purpose of this study is to examine whether olanzapine, compared to risperidone, can provide more adequate and timely control of behavioral agitation in acutely ill subjects with schizophrenia.

Condition	Intervention	Phase
Schizophrenia	Drug: Olanzapine Hydrochloride Drug: Risperidone	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Managing Acute Schizophrenia, a Double Blind Comparison Between Two Atypical Antipsychotics - Olanzapine and Risperidone

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia

Drug Information available for: Risperidone Olanzapine

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

To determine if the efficacy of oral dose of olanzapine is greater than oral dose of risperidone in acute schizophrenia by comparing changes in agitation from baseline to 3 days post-first oral dose

Secondary Outcome Measures:

To assess the efficacy of olanzapine compared with risperidone, in reduction of scores from baseline to 3 days as measured by the BPRS-T, PANSS-P, ACES, CGI-I and CGI-S.
To assess the efficacy of olanzapine compared with risperidone, in reduction of scores from baseline to 6 weeks of acute treatment in the BPRS-T
To assess the efficacy of olanzapine compared with risperidone, in reduction of scores from baseline to 6 weeks of acute treatment in the PANSS
To compare the change in severity of akathasia in schizophrenic patients between olanzapine and risperidone as measured by the BAS within the 6-week treatment period
To compare the change of severity of extrapyramidal symptoms within the 6 week treatment with olanzapine and risperidone, as measured by the SAS

Enrollment:	122
Study Start Date:	April 2003
Study Completion Date:	December 2003

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female subjects, aged 18 - 60
Subjects must meet a clinical diagnosis of schizophrenia, schizophreniform disorder, or schizoaffective disorder according to DSM-IV
Subjects' illness must not, in the opinion of the investigator, be caused by substance abuse
BPRS total score (1 to 7 scale) of greater than or equal to 36 at visit 1
Subjects must have a minimum total score of greater than or equal to 14 on the five items of the PANSS-EC and at least one individual item score of greater than or equal to 4 using the 1-7 scoring system prior to first dose of double-blind medications

Exclusion Criteria:

Treatment with antipsychotics or benzodiazepines within 4 hours prior to the first study drug administration
Treatment with an injectable depot neuroleptic within 1 injection interval prior to study drug administration
Electroconvulsive therapy (ECT) within 1 month (90 days) prior to study entry (visit 1)
Treatment with remoxipride within 6 months (180 days) prior to visit 1
Documented history of allergic reaction to study medications

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00485498

Locations

China
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.
Beijing, China

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:

Lilly Clinical Trial Registry This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00485498 History of Changes
Other Study ID Numbers:	6704, F1D-GH-S036
Study First Received:	June 11, 2007
Last Updated:	June 11, 2007
Health Authority:	China: State Food and Drug Administration

Additional relevant MeSH terms:

Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Antipsychotic Agents
Risperidone
Olanzapine
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Dopamine Antagonists
Dopamine Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on February 09, 2012