Trial intelligence / Profile preview

Olanzapine vs Risperidone in Acute Schizophrenia

NCT00485498Phase 4

Key facts

Status: Completed
Start: Apr 2003
Countries: 1
Sponsor: Eli Lilly and Company
Modality: Small Molecules

Drugs: olanzapine
Conditions: schizophrenia

Overview

Phase 4, randomised, double-blind trial of olanzapine in schizophrenia (2 arms), sponsored by Eli Lilly and Company. Primary endpoint: Change in agitation at 3 days. Started Apr 2003; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

Olanzapine
Oral Olanzapine
Risperidone
Oral Risperidone

Who it enrols

Adult patients with acute schizophrenia, schizophreniform disorder, or schizoaffective disorder exhibiting significant agitation (PANSS-EC >= 14) and overall symptom severity (BPRS >= 36).

Endpoints

Primary

Change in agitation3 days

Secondary

Brief Psychiatric Rating Scale - Total6 weeks
Positive and Negative Syndrome Scale - Positive3 days
Agitation-Calmness Evaluation Scale3 days
Clinical Global Impressions - Improvement3 days
Clinical Global Impressions - Severity3 days
Positive and Negative Syndrome Scale6 weeks
Severity of akathisia (BAS)6 weeks
Severity of extrapyramidal symptoms (SAS)6 weeks

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