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

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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

130 participants in 2 patient groups

Olanzapine
Experimental group
Treatment:
Drug: olanzapine
Risperidone
Active Comparator group
Treatment:
Drug: risperidone

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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