Managing Acute Schizophrenia, a Comparison Between Two Atypical Antipsychotics
This study has been completed.
Sponsor:
Eli Lilly and Company
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00485498
First received: June 11, 2007
Last updated: NA
Last verified: June 2007
History: No changes posted
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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 4 |
| 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:
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:
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: 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 May 23, 2013