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Managing Acute Schizophrenia, a Comparison Between Two Atypical Antipsychotics

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ClinicalTrials.gov Identifier: NCT00485498
Recruitment Status : Completed
First Posted : June 13, 2007
Last Update Posted : June 13, 2007
Sponsor:
Information provided by:
Eli Lilly and Company

Brief Summary:
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 or disease Intervention/treatment Phase
Schizophrenia Drug: Olanzapine Hydrochloride Drug: Risperidone Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 122 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Managing Acute Schizophrenia, a Double Blind Comparison Between Two Atypical Antipsychotics - Olanzapine and Risperidone
Study Start Date : April 2003
Actual Study Completion Date : December 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources




Primary Outcome Measures :
  1. 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 :
  1. 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.
  2. 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
  3. To assess the efficacy of olanzapine compared with risperidone, in reduction of scores from baseline to 6 weeks of acute treatment in the PANSS
  4. 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
  5. To compare the change of severity of extrapyramidal symptoms within the 6 week treatment with olanzapine and risperidone, as measured by the SAS


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
ClinicalTrials.gov Identifier: NCT00485498     History of Changes
Other Study ID Numbers: 6704
F1D-GH-S036
First Posted: June 13, 2007    Key Record Dates
Last Update Posted: June 13, 2007
Last Verified: June 2007

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Risperidone
Antipsychotic Agents
Olanzapine
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators