Status:
COMPLETED
Efficacy Study of Early Onset of Antipsychotic Drug Action in Schizophrenia
Lead Sponsor:
Eli Lilly and Company
Conditions:
Schizophrenia
Schizoaffective Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
The current study has been designed to address the significance of early onset of response prospectively in patients treated with an atypical antipsychotic.
Eligibility Criteria
Inclusion
- Patients must demonstrate acute psychopathologic severity criteria and be at least moderately ill.
- Patients must have experienced an exacerbation of their illness within the previous 2 weeks.
- Patients in whom a switch to another antipsychotic medication is acutely indicated.
Exclusion
- Patients who are deemed nonresponsive to risperidone or olanzapine.
- Patients who have been hospitalized for greater than 2 weeks immediately prior to Visit 1.
- Patients having received olanzapine or risperidone in the past 30 days.
- Treatment with clozapine within 1 year prior to Visit 1.
- Diagnosis of substance-induced psychosis by Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria within 7 days of Visit 1 (or at any time during the study), or confirmed on clinical grounds within 72 hours subsequent to Visit 1 (or at any time during the study).
- A diagnosis of Parkinson's disease, dementia-related psychosis, or related disorders.
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
628 Patients enrolled
Trial Details
Trial ID
NCT00337662
Start Date
May 1 2006
End Date
December 1 2007
Last Update
February 17 2010
Active Locations (34)
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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.
Little Rock, Arkansas, United States, 72201
2
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.
Escondido, California, United States, 92025
3
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.
Garden Grove, California, United States, 92845
4
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.
Glendale, California, United States, 91206