A Study Using Rapid Acting Intramuscular Olanzapine in Agitated Patients With Schizophrenia

Lilly

Status and phase: Completed; Phase 2

Conditions: Schizophrenia

Treatments: Drug: olanzapine-RAIM; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00316238

5294

F1D-JE-RA02

Details and patient eligibility

About

To investigate dose-response of Rapid Acting Intramuscular Olanzapine in Agitated Patients with Schizophrenia

Enrollment: 160 estimated patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients must have schizophrenia that meets disease diagnostic criteria in DSM-IV-TR
• Patients must be inpatients during the study
• Patients must have a minimum total score of no less than 14 on the five items of the PANSS-EC and at least one individual item score of no less than 4 using the 1-7 scoring system prior to the first injection of study drug

Exclusion criteria

• Patients who have a known history of diabetes mellitus.
• Patients who have received treatment with antipsychotics or other prohibited concomitant medicines within 2 hours prior to the first IM study drug administration
• Patients who have had treatment with benzodiazepines within 4 hours prior to first IM study drug administration.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind