Comparison of Intramuscular Olanzapine and Intramuscular Haloperidol in Patients With Schizophrenia

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00485901
First received: June 11, 2007
Last updated: NA
Last verified: June 2007
History: No changes posted
  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 3

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


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
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: 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:
No publications provided

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

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Haloperidol
Olanzapine
Haloperidol decanoate
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents

ClinicalTrials.gov processed this record on July 20, 2014