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OpenTrials
Completed

NCT Number: NCT00044005

Safety and Tolerability Study of Drug to Treat Schizophrenia

The purpose of this study is to evaluate the long-term safety of SM-13496 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 2

Primary location

Birmingham Psychiatry Pharmaceutical, Birmingham, Alabama, 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

  • Successful completion of participation in protocol #D1050049

Exclusion criteria

  • Substance abuse
  • Prolactin level of ≥200ng/mL at baseline
  • Pregnancy

Treatment and study plan

Lurasidone 20 mg

Drug

Lurasidone 20mg oral tablet taken once daily for 6-months

Lurasidone 40 mg

Drug

Lurasidone 40mg oral tablets taken once daily

Lurasidone 80mg

Drug

Lurasidone 80mg oral tablet taken once daily

Primary outcomes

  1. Number of Participants With Adverse Events

    Time frame: 6-months

    The primary objective of this 6-month open-label study was to evaluate the safety of 3 doses of lurasidone.

Sponsors and collaborators

Lead sponsor

Sumitomo Pharma America, Inc.

Industry

Registry information

Official study title

A Randomized, Open-Label, Dose-Blinded, Multicenter, 6-Month Study of Safety and Tolerability of 3 Dose Levels of SM-13496 (Lurasidone) in Patients With Schizophrenia

Important dates

Study start
2002
Primary completion
2003
Study completion
2003
First posted
Aug 20, 2002
Registry last updated
Apr 17, 2014

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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