Managing Acute Schizophrenia, a Comparison Between Two Atypical Antipsychotics

• Sponsor: Eli Lilly and Company (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00485498
• Collaborator: (none)
• Enrollment: 122
• Location: 1
• Duration (Months): 8
• Patients Per Site Per Month: 15.2

Study Details

Study Description

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 Design

• Study Type: Interventional
• 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: Apr 1, 2003
• Actual Study Completion Date: Dec 1, 2003

Outcome Measures

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 []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

• Treatment with remoxipride within 6 months (180 days) prior to visit 1

• Documented history of allergic reaction to study medications

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Lilly Clinical Trial Registry

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00485498
• Other Study ID Numbers: 6704; F1D-GH-S036
• First Posted: Jun 13, 2007
• Last Update Posted: Jun 13, 2007
• Last Verified: Jun 1, 2007

• Additional relevant MeSH terms: Schizophrenia; Olanzapine; Risperidone

Study Results

No Results Posted as of Jun 13, 2007