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Completed

NCT Number: NCT01485640

Lurasidone Extended Use Study

This is an open-label continuation study designed to monitor the safety, tolerability and effectiveness of lurasidone in subjects who have completed participation in a lurasidone extension study (NCT00868959 and NCT01566162) and who may benefit from continued treatment with lurasidone.

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Key information

Conditions

Schizophrenia Bipolar Disorder Bipolar and Related Disorders Mental Disorders Mood Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Okanagan Clinical Trials, Kelowna, British Columbia, Canada

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • The subject or legal guardian provides written informed consent. For eligible subjects under age 18, verbal assent is also required.
  • The subject has completed the extension phase of a prior lurasidone clinical study. Eligible subjects may enroll into this continuation study directly (or within 10 days) after completing the extension phase of a prior lurasidone clinical study. Subjects that have completed an extension study prior to the initiation of this protocol at the study site, may participate in this study up to 3 months after completion of the extension phase of the prior lurasidone study.
  • The subject is judged by the Investigator to be suitable for participation in a clinical study involving open-label lurasidone treatment and is able to comply with the protocol.
  • The subject, in the Investigator's judgment, may benefit from continued treatment with lurasidone

Exclusion criteria

  • The subject is considered by the Investigator, to be at imminent risk for homicidal or suicidal behavior.
  • The subject resides in a country where lurasidone has been approved for any indication.
  • The subject is currently enrolled in any other investigational study.
  • The subject answers "yes" to "Suicidal Ideation" Items 4 or 5 on the Columbia Suicide Severity Rating Scale (C-SSRS).

Treatment and study plan

Lurasidone

Drug

Lurasidone flexibly dosed; doses of 20, 40, 60 or 80 mg/day will be taken orally with food

Primary outcomes

  1. Number of Subjects With Treatment Emergent AEs, SAEs or Who Discontinued Due to AEs

    Time frame: 18 months

    Primary Safety assessments included spontaneous adverse event (AE) and serious adverse events (SAEs) monitoring.

Secondary outcomes

  1. Change From Baseline to Month 18 (LOCF) in the Clinical Global Impression Severity Score (CGI-S

    Time frame: 18 months

    The CGI-S score is a single value, clinician-rated assessment of illness severity and ranges from 1= 'Normal, not at all ill' to 7= 'Among the most extremely ill patients'. 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 Long-term, Multicenter, Open-Label, Flexible Dose Continuation Study in Subjects Who Have Completed a Prior Lurasidone Study

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Dec 5, 2011
Registry last updated
Nov 4, 2016

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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