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OpenTrials
Completed

NCT Number: NCT00088049

Study of Olanzapine vs. Aripiprazole in the Treatment of Schizophrenia

The purpose of the protocol is to evaluate the efficacy of olanzapine compared with Aripiprazole in patients with schizophrenia.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. test, Little Rock, Arkansas, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female inpatient or outpatients, ages 18-65

Exclusion criteria

  • Participation in a clinical trial of another drug including olanzapine or aripiprazole within 30 days prior to study entry (visit 1).
  • Treatment with clozapine within the past 12 months.
  • Have known uncorrected narrow-angle glaucoma.
  • Have a diagnosis of Parkinson's disease, dementia or related disorder

Treatment and study plan

Olanzapine

Drug

Aripiprazole

Drug

Primary outcomes

  1. To determine the long-term effectiveness and tolerability as measured by time to all-cause treatment discontinuation of olanzapine and aripiprazole relative to each other in patients with schizophrenia during 28 weeks of double-blind therapy

Secondary outcomes

  1. To assess olanzapine versus aripiprazole in the following:

  2. improvement in psychopathology of schizophrenia as measured by PANSS change

  3. change in CGI-S and PGI-I scores

  4. level of activation as measured by PANSS change

  5. depressive symptoms as measured by MADRS score

  6. response rates

  7. time to failure to maintain response

  8. quality of life as measured by the SWN-S and SF-36

  9. cognitive functioning as measured by the MOS

  10. sexual functioning as measured by the GISF

  11. health resource utilization and resource utilization costs

  12. hospitalization time

  13. treatment emergent adverse events

  14. EPS as measured by the Simpson-Angus, Barnes, and AIMS

  15. laboratory values

  16. vital signs

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Randomized Double-Blind Study of Olanzapine Versus Aripiprazole in the Treatment of Schizophrenia

Important dates

Study start
2003
Study completion
2007
First posted
Jul 21, 2004
Registry last updated
Jul 18, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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