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Efficacy of High Dose Olanzapine for the Treatment of Schizophrenia and Schizoaffective Disorder

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Lilly

Status and phase

Completed
Phase 4

Conditions

Schizophrenia
Schizoaffective Disorder

Treatments

Drug: Olanzapine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00100776
F1D-US-HGLF
8333

Details and patient eligibility

About

The purposes of this study are to assess the efficacy, safety, and side effects among doses approved by the Food and Drug Administration and higher (not FDA approved) doses of olanzapine in patients with schizophrenia or schizoaffective disorder.

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • You must be 18 to 60 years old
  • You must have been diagnosed with schizophrenia or schizoaffective disorder
  • You must be able to visit the doctor's office 8 times over a 9 week period
  • You must agree to participate with all tests and examinations that are required for this study

Exclusion criteria

  • You are a woman and are pregnant or breastfeeding
  • You presently have an acute or unstable medical illness
  • You have a history of an allergic reaction to olanzapine
  • You are taking medications that are not permitted in this study. Your physician will discuss these with you
  • You have taken part in another clinical research trial within the last 30 days or you have received treatment with a drug in the last 30 days that has not received regulatory approval.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

33

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Data sourced from clinicaltrials.gov

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