Comparison of Intramuscular Olanzapine and Intramuscular Haloperidol in Patients With Schizophrenia - Full Text View

Sponsor:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00485901

Purpose

The purpose of this study is to compare intramuscular Olanzapine and intramuscular Haloperidol in changing of agitation in patients with schizophrenia

Condition	Intervention	Phase
Schizophrenia	Drug: Olanzapine Hydrochloride Drug: Haloperidol	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Double-Blind Randomized Comparison of the Efficacy and Safety of Intramuscular Olanzapine and Intramuscular Haloperidol in Acutely Agitated Patients With Schizophrenia

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia

Drug Information available for: Haloperidol Haloperidol decanoate Haloperidol lactate Olanzapine

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

Assess the efficacy of IM olanzapine compared with IM haloperidol in changing of agitation from baseline to 2 hours post-first IM injection

Secondary Outcome Measures:

Assess treatment-emergent adverse events, change in vital signs and extrapyramidal symptoms of IM olanzapine versus IM haloperidol during the study
Assess the efficacy of IM olanzapine compared with IM haloperidol from baseline to 15 min, 30 min, 60 min and 120 minutes post-first IM injection
Compare the response rates and time to response during the 2 hours post-first IM injection.

Enrollment:	50
Study Start Date:	July 2004
Study Completion Date:	January 2005

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female patients, between the ages of 18 and 65
Patients must have diagnosis of schizophrenia that meets disease diagnostic criteria as defined in DSM-IV
Patients must be considered, by the investigator, to be clinically agitated and appropriate candidates for treatment with IM medication. Investigator must believe that it is safe to administer IM olanzapine and IM comparator to the patients with respect to the safety profile of these drugs (including the anticholinergic properties of Olanzapine IM or the comparator agent)
Subjects' illness must not, in the opinion of the investigator, be caused by substance abuse
Patient must be hospitalized during the study

Exclusion Criteria:

Previous participation (treatment with study drug) in a Lilly sponsored intra-muscular olanzapine clinical trial
Serious, unstable illnesses such that death is anticipated within 1 year or intensive care unit hospitalization for the disease is anticipated within 6 months
Have a known diagnosis of dementia of any type, as defined in the DSM-IV or DSM-IV-TR
Documented history of allergic reaction to study medication(s)
Treatment with an injectable depot neuroleptic within 1 injection interval prior to study drug administration

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00485901

Locations

Taiwan
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.
Taipei, Taiwan

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:	6409, F1D-TW-S025
Study First Received:	June 11, 2007
Last Updated:	June 11, 2007
ClinicalTrials.gov Identifier:	NCT00485901 History of Changes
Health Authority:	Taiwan: Institutional Review Board

Additional relevant MeSH terms:

Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Olanzapine
Psychotropic Drugs
Antiemetics
Haloperidol
Schizophrenia
Mental Disorders
Therapeutic Uses
Schizophrenia and Disorders with Psychotic Features

Tranquilizing Agents
Gastrointestinal Agents
Central Nervous System Depressants
Dopamine Antagonists
Antipsychotic Agents
Serotonin Uptake Inhibitors
Pharmacologic Actions
Haloperidol decanoate
Serotonin Agents
Autonomic Agents
Dopamine Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 27, 2009