A Study Using Rapid Acting Intramuscular Olanzapine in Agitated Patients With Schizophrenia - Full Text View

Sponsor:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00316238

Purpose

To investigate dose-response of Rapid Acting Intramuscular Olanzapine in Agitated Patients with Schizophrenia

Condition	Intervention	Phase
Schizophrenia	Drug: olanzapine-RAIM Drug: placebo	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Double-Blind Dose-Response Study Comparing Rapid Acting Intramuscular Olanzapine and Intramuscular Placebo in Agitated Patients With Schizophrenia

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia

Drug Information available for: Olanzapine

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

To evaluate dose-response relationship and to confirm the efficacy of IM olanzapine by sequentially comparing each of IM olanzapine groups and IM placebo group with respect to the changes from baseline to 2 hours post first IM injection of agitation.

Secondary Outcome Measures:

To determine if the efficacy of IM olanzapine is greater than IM placebo by evaluating sequentially comparing changes at 30 min, 60 min, 90 min post first IM injection of agitation, as measured by the PANSS-EC in schizophrenia patients.
To determine if the efficacy of IM olanzapine groups are greater than the IM placebo by evaluating sequentially changes from baseline to 2 hours post first IM injection in the rate of responder, CGI-I, and ACES.
To examine whether a dose-response relationship exists for IM olanzapine in higher agitation, by using mean changes of PANSS-EC total score from baseline to 2 hours post first IM injection as measured by PANSS-EC (Score total no less than 20).
To compare the efficacy of IM olanzapine(2.5, 5, 7.5, or 10 mg) to IM placebo by evaluating sequentially changes from baseline to 24 hours post first IM injection in the PANSS-EC, CGI-S, Clinical Global Impression-Improvement of Illness (CGI-), and ACES.
To compare efficacy of IM olanzapine(2.5, 5, 7.5, or 10 mg)to IM placebo in the frequency of patients who need second injection and time to second injection.
To compare the safety of IM olanzapine groups to IM placebo group over a 24 hours period in terms of ACES, TEAE, changes in laboratory values, pulse, blood pressure, ECG, DIEPSS.

Estimated Enrollment:	160
Study Start Date:	April 2006
Study Completion Date:	May 2007

Eligibility

Ages Eligible for Study:	20 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients must have schizophrenia that meets disease diagnostic criteria in DSM-IV-TR
Patients must be inpatients during the study
Patients must have a minimum total score of no less than 14 on the five items of the PANSS-EC and at least one individual item score of no less than 4 using the 1-7 scoring system prior to the first injection of study drug

Exclusion Criteria:

Patients who have a known history of diabetes mellitus.
Patients who have received treatment with antipsychotics or other prohibited concomitant medicines within 2 hours prior to the first IM study drug administration
Patients who have had treatment with benzodiazepines within 4 hours prior to first IM study drug administration.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00316238

Locations

Japan
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.
Okayama, Japan, 719-3141
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.
Kagoshima, Japan, 899-5652
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.
Akita, Japan, 010-1654
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.
Fukushima, Japan, 966-0902
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.
Tottori, Japan, 682-0023
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.
Tokyo, Japan, 187-8551
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.
Nagano, Japan, 384-8540
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.
Fukuoka, Japan, 832-0077
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.
Hiroshima, Japan, 723-0003
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.
Yamagata, Japan, 999-2221
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.
Hokkaido, Japan, 004-0841
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.
Gunma, Japan, 377-0055
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.
Osaka, Japan, 561-0803
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.
Okinawa, Japan, 904-2222
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.
Kumamoto, Japan, 861-0002

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

Study ID Numbers:	5294, F1D-JE-RA02
Study First Received:	April 18, 2006
Last Updated:	June 6, 2007
ClinicalTrials.gov Identifier:	NCT00316238 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:

Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Gastrointestinal Agents
Olanzapine
Psychotropic Drugs
Antiemetics
Central Nervous System Depressants
Antipsychotic Agents

Serotonin Uptake Inhibitors
Pharmacologic Actions
Schizophrenia
Serotonin Agents
Autonomic Agents
Mental Disorders
Therapeutic Uses
Peripheral Nervous System Agents
Central Nervous System Agents
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on February 08, 2010