Lurasidone Extended Use Study

Phase 3

Completed

• Conditions: Schizophrenia; Bipolar Disorder
• Interventions: Drug: Lurasidone

• Registration Number: NCT01485640
• Lead Sponsor: Sumitomo Pharma America, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-12-01
• Study First Submitted QC: 2011-12-02
• Study First Posted: 2011-12-05
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Results First Submitted: 2015-02-26
• Results First Submitted QC: 2015-02-26
• Results First Posted: 2015-03-11
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-29
• Last Update Posted: 2016-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 162

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lurasidone	Lurasidone	Lurasidone flexibly dosed

Primary Outcome Measures

Name	Time	Method
Number of Subjects With Treatment Emergent AEs, SAEs or Who Discontinued Due to AEs	18 months	Primary Safety assessments included spontaneous adverse event (AE) and serious adverse events (SAEs) monitoring.

Secondary Outcome Measures

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

Trial Locations

Locations (46)

Okanagan Clinical Trials; 🇨🇦 Kelowna, British Columbia, Canada

Centro de Investigaciones y Proyectos en Neurociencias CIPNA Investigations; 🇨🇴 Barranquilla, Colombia

E.S.E. Hospital Mental de Antioquia; 🇨🇴 Bello, Colombia

CISNE - UIC Campo Abierto; 🇨🇴 Bogota, Colombia

Psychiatricka ambulance; 🇨🇿 Brno-mesto, Czech Republic

Vojenska nemocnice Olomouc; 🇨🇿 Olomouc, Czech Republic

Clintrial, s.r.o.; 🇨🇿 Praha, Czech Republic

Psychiatry Trial s.r.o.; 🇨🇿 Praha, Czech Republic

Medical Services Prague s.r.o.; 🇨🇿 Praha, Czech Republic

Zans Ritter, Marcel; 🇫🇷 Orvault, France

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