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NCT Number: NCT00615433

Lurasidone HCl A Phase 3 Study of Patients With Acute Schizophrenia

Lurasidone HCl is a compound developed for the treatment of schizophrenia. This clinical study is designed to test the hypothesis that lurasidone is more efficacious than placebo. The study will also evaluate the safety and tolerability of lurasidone as compared to placebo.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Instituto Colombiano del Sistema Nervioso Clinica Montserrat, Cundinamarca, Bogota D.C., Colombia

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Provide written informed consent and aged between 18 and 75 years of age.
  • Meets DSM-IV criteria for a primary diagnosis of schizophrenia.
  • Not pregnant, if of reproductive potential agrees to remain abstinent or use adequate and reliable contraception for duration of study.
  • Able and agrees to remain off prior antipsychotic medication for the duration of study.
  • Good physical health on the basis of medical history, physical examination, and laboratory screening.
  • Willing and able to comply with the protocol, including the inpatient requirements and outpatient visits.

Exclusion criteria

  • Considered by the investigator to be at imminent risk of suicide or injury to self, others or property.
  • Any chronic organic disease of the CNS (other than schizophrenia).
  • Used investigational compound within 30 days.
  • Clinically significant or history of alcohol abuse/alcoholism or drug abuse/dependence within the last 6 months

Treatment and study plan

Lurasidone

Drug

120mg/day

Olanzapine

Drug

15mg/day

placebo comparator

Drug

Placebor Comparator

Lurasidone 40 mg tablets

Drug

Lurasidone 40 mg tablets

Primary outcomes

  1. Change in Total PANSS (Positive and Negative Syndrome Scale)Score From Baseline to the End of the Double Blind Treatment Period.

    Time frame: Baseline and 6 weeks

    The PANSS is a 30-item rating instrument evaluating the presence/absence and severity of positive, negative and general psychopathology of schizophrenia. The scale was developed from the BPRS and the Psychopathology Rating Scale. All 30 items are rated on a 7-point scale (1=absent; 7=extreme). The total score can range from 30 to 210. Lower scores represent less severity of illness.

Secondary outcomes

  1. CGI-S (Clinical Global Impression - Severity) Change From Baseline to the End of the Double-blind Treatment.

    Time frame: 6 weeks

    The CGI-S is a clinician-rated assessment of the subject's current illness state on a 7-point scale, where a higher score is associated with greater illness severity.

Sponsors and collaborators

Lead sponsor

Sumitomo Pharma America, Inc.

Industry

Registry information

Official study title

A Phase 3 Randomized, Placebo-and Active Comparator Controlled, Clinical Trial to Study the Safety and Efficacy of Two Doses of Lurasidone HCl in Acutely Psychotic Patients With Schizophrenia.

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
Feb 14, 2008
Registry last updated
Jun 12, 2015

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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