Overview

Efficacy Study of Early Onset of Antipsychotic Drug Action in Schizophrenia

Status:
Completed
Trial end date:
2007-12-01
Target enrollment:
0
Participant gender:
All
Summary
The current study has been designed to address the significance of early onset of response prospectively in patients treated with an atypical antipsychotic.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Eli Lilly and Company
Treatments:
Antipsychotic Agents
Olanzapine
Risperidone
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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.