Efficacy Study of Early Onset of Antipsychotic Drug Action in Schizophrenia

Lilly

Status and phase: Completed; Phase 4

Conditions: Schizophreniform Disorder; Schizophrenia; Schizoaffective Disorder

Treatments: Drug: risperidone; Drug: olanzapine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00337662

10769

F1D-US-HGMN (Other Identifier)

Details and patient eligibility

About

The current study has been designed to address the significance of early onset of response prospectively in patients treated with an atypical antipsychotic.

Enrollment: 628 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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628 participants in 3 patient groups

1

Experimental group

Description:

Olanzapine for Not Early Onset response (NEO) patients

Treatment:

Drug: olanzapine

2

Active Comparator group

Description:

Risperidone for Not Early Onset response (NEO) patients

Treatment:

Drug: risperidone

Drug: risperidone

3

Active Comparator group

Description:

Risperidone for Early Onset response (EO) patients

Treatment:

Drug: risperidone

Drug: risperidone