Lurasidone Extended Use Study
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 162
- 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
- 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)
Spitalul Clinic de Neuropsihiatrie Craiova
🇷🇴Craiova, Romania
Psychiatricka ambulance
🇨🇿Brno-mesto, Czech Republic
Vojenska nemocnice Olomouc
🇨🇿Olomouc, Czech Republic
Mental Health Treatment Rehabililitation Foundation Dept. of Psychiatry
🇮🇳Ahmedabad, Gujarat, India
Kherson Regional Psychiatric Hospital
🇺🇦Kherson, Vil Stepanivka, Ukraine
R.K. Yadav Memorial Mental Health & De-Addiction Hospital Psychiatry
🇮🇳Jaipur, Rajasthan, India
E.S.E. Hospital Mental de Antioquia
🇨🇴Bello, Colombia
Okanagan Clinical Trials
🇨🇦Kelowna, British Columbia, Canada
Centro de Investigaciones y Proyectos en Neurociencias CIPNA Investigations
🇨🇴Barranquilla, Colombia
CISNE - UIC Campo Abierto
🇨🇴Bogota, Colombia
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
Vijayawada Institute of Mental Health and Neurosciences
🇮🇳Vijayawada, Andhra Pradesh, India
Brain Mind Behavior Neuroscience Research Institute
🇮🇳Vishakhapatnam, Andh Prad, India
Hôpital Chalucet, Centre hospitalier intercommunal de Toulon la Seyne sur mer (CHITS)
🇫🇷Toulun, France
Samvedna Hospitals
🇮🇳Ahmedabad, Gujarat, India
Seth K M School of P G Medicine & Research
🇮🇳Ahmedabad, Gujarat, India
Hatkesh Healthcare Foundation
🇮🇳Junagadh, Gujarat, India
Brij Psychiatry Hospital & Muskaan Research Centre
🇮🇳Vadodara, Gujarat, India
Shanti Nursing Home
🇮🇳Aurangabad, Maharashtra, India
Dr. Tambi's Neuropsychiatry Center
🇮🇳Jaipur, Rajaasthan, India
Neuromeda JSC
🇱🇹Kaunas, Lithuania
Mahendru Psychiatric Centre
🇮🇳Kanpur, India
JSC Neuromeda
🇱🇹Kaunas, Lithuania
Seskines Outpatient Clinic, Public Institution
🇱🇹Vilnius, Lithuania
Spitalul Clinic Judetean de Urgenta Cluj
🇷🇴Cluj-Napoca, Romania
Regional Government Institution (RGI) 'Lipetsk Regional Psychoneurology Hospital'
🇷🇺Lipetsk, Russian Federation
St. Petersburg State Government Healthcare Institution "City Psychiatric Hospital #4" (St. Petersburg Insane Asylum Distributor)
🇷🇺St. Petersburg, Russian Federation
St. Petersburg State Budgetary Healthcare Institution 'City Psychoneurology Dispensary #7 (with In-Patient Department)', (SPb SBHI "CPNDD-7"), at Daycare Facility #1
🇷🇺St. Petersburg, Russian Federation
Institute of Mental Health
🇷🇸Belgrade, Serbia
St. Petersburg State Healthcare Institution (SPbSHI) "City Psychiatric Hospital #6"
🇷🇺St. Petersburg, Russian Federation
Clinical Centre Nis, Clinic for mental health protection
🇷🇸Nis, Serbia
PsychoLine s.r.o. Psychiatricka ambulancia
🇸🇰Rimavska Sobota, Slovakia
Psychiatricka ambulancia Mentum s.r.o.
🇸🇰Bratislava, Slovakia
Dey Clinic
🇿🇦Pretoria, Gauteng, South Africa
Centrum zdravia R.B.K. s.r.o. Psychiatricka ambulancia
🇸🇰Svidnik, Slovakia
Pro mente sana s.r.o. Psychiaricka ambulancia
🇸🇰Trencin, Slovakia
Cape Trial Centre
🇿🇦Tygervalley, Western Cape, South Africa
Denmar Hospital Consulting Rooms
🇿🇦Pretoria, South Africa
Regional Clinical Psychiatric Hospital, Dept #11
🇺🇦Donetsk, Ukraine
Dnipropetrovsk Regional Clinical Hospital named Mechnikov
🇺🇦Dnipropetrovsk, Ukraine
Institute of Neurology, Psychiatry and Narcology, NAMS of Ukraine
🇺🇦Khardov, Ukraine
Crimean republican Clinical Psychiatric Hospital
🇺🇦Simferopol, Ukraine
Reg. Psych. Hosp.n.a.O.Yuschenko, Dept #21
🇺🇦Vinnitsia, Ukraine