Safety Study of Olanzapine and a Comparator in Patients With Schizophrenia and Schizoaffective Disorder

Lilly

Status and phase: Completed; Phase 4

Conditions: Schizophrenia; Schizoaffective Disorder

Treatments: Drug: risperidone; Drug: olanzapine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00190749

5296

F1D-MC-S014 (Other Identifier)

Details and patient eligibility

About

This study will assess whether olanzapine and/or risperidone affect the way the human body uses sugar in the blood.

Enrollment: 130 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18-65 years old
• Diagnosed with Schizophrenia or Schizoaffective disorder
• Ability to visit the doctor's office for scheduled visits

Exclusion criteria

• Women who are pregnant or breastfeeding
• Have a body mass index (BMI) greater than 40
• Have diabetes, heart disease or any other unstable illness
• Have known positive human immunodeficiency virus (HIV)
• Are currently taking olanzapine, risperidone, clozapine, glucocorticoids, injectable antipsychotics

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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130 participants in 2 patient groups

Olanzapine

Experimental group

Treatment:

Drug: olanzapine

Risperidone

Active Comparator group

Treatment:

Drug: risperidone