Clinical trial NCT01485640: Lurasidone Extended Use Study
Official title: A Long-term, Multicenter, Open-Label, Flexible Dose Continuation Study in Subjects Who Have Completed a Prior Lurasidone Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Bipolar Disorder
Keywords: Schizophrenia
bipolar disorder
Lurasidone
Latuda
Lead sponsor: Sumitomo Pharma America, Inc.
Sponsor class: INDUSTRY
First posted: 2011-12-05
Enrollment: 162
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Number of Subjects With Treatment Emergent AEs, SAEs or Who Discontinued Due to AEs
timeFrame: 18 months
Secondary outcomes:
measure: Change From Baseline to Month 18 (LOCF) in the Clinical Global Impression Severity Score (CGI-S
timeFrame: 18 months
Other outcomes:
Locations:
city: Kelowna
country: Canada
facility: Okanagan Clinical Trials
state: British Columbia
city: Barranquilla
country: Colombia
facility: Centro de Investigaciones y Proyectos en Neurociencias CIPNA Investigations
city: Bello
country: Colombia
facility: E.S.E. Hospital Mental de Antioquia
city: Bogota
country: Colombia
facility: CISNE - UIC Campo Abierto
city: Brno-mesto
country: Czech Republic
facility: Psychiatricka ambulance
city: Olomouc
country: Czech Republic
facility: Vojenska nemocnice Olomouc
city: Praha
country: Czech Republic
facility: Clintrial, s.r.o.
city: Praha
country: Czech Republic
facility: Psychiatry Trial s.r.o.
city: Praha
country: Czech Republic
facility: Medical Services Prague s.r.o.
city: Orvault
country: France
facility: Zans Ritter, Marcel
city: Toulun
country: France
facility: Hôpital Chalucet, Centre hospitalier intercommunal de Toulon la Seyne sur mer (CHITS)
city: Vishakhapatnam
country: India
facility: Brain Mind Behavior Neuroscience Research Institute
state: Andh Prad
city: Vijayawada
country: India
facility: Vijayawada Institute of Mental Health and Neurosciences
state: Andhra Pradesh
city: Ahmedabad
country: India
facility: Samvedna Hospitals
state: Gujarat
city: Ahmedabad
country: India
facility: Seth K M School of P G Medicine & Research
state: Gujarat
city: Ahmedabad
country: India
facility: Mental Health Treatment Rehabililitation Foundation Dept. of Psychiatry
state: Gujarat
city: Junagadh
country: India
facility: Hatkesh Healthcare Foundation
state: Gujarat
city: Vadodara
country: India
facility: Brij Psychiatry Hospital & Muskaan Research Centre
state: Gujarat
city: Aurangabad
country: India
facility: Shanti Nursing Home
state: Maharashtra
city: Jaipur
country: India
facility: Dr. Tambi's Neuropsychiatry Center
state: Rajaasthan
city: Jaipur
country: India
facility: R.K. Yadav Memorial Mental Health & De-Addiction Hospital Psychiatry
state: Rajasthan
city: Kanpur
country: India
facility: Mahendru Psychiatric Centre
city: Kaunas
country: Lithuania
facility: Neuromeda JSC
city: Kaunas
country: Lithuania
facility: JSC Neuromeda
city: Vilnius
country: Lithuania
facility: Seskines Outpatient Clinic, Public Institution
city: Cluj-Napoca
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Cluj
city: Craiova
country: Romania
facility: Spitalul Clinic de Neuropsihiatrie Craiova
city: Lipetsk
country: Russian Federation
facility: Regional Government Institution (RGI) 'Lipetsk Regional Psychoneurology Hospital'
city: St. Petersburg
country: Russian Federation
facility: St. Petersburg State Budgetary Healthcare Institution 'City Psychoneurology Dispensary #7 (with In-Patient Department)', (SPb SBHI "CPNDD-7"), at Daycare Facility #1
city: St. Petersburg
country: Russian Federation
facility: St. Petersburg State Government Healthcare Institution "City Psychiatric Hospital #4" (St. Petersburg Insane Asylum Distributor)
city: St. Petersburg
country: Russian Federation
facility: St. Petersburg State Healthcare Institution (SPbSHI) "City Psychiatric Hospital #6"
city: Belgrade
country: Serbia
facility: Institute of Mental Health
city: Nis
country: Serbia
facility: Clinical Centre Nis, Clinic for mental health protection
city: Bratislava
country: Slovakia
facility: Psychiatricka ambulancia Mentum s.r.o.
city: Rimavska Sobota
country: Slovakia
facility: PsychoLine s.r.o. Psychiatricka ambulancia
city: Svidnik
country: Slovakia
facility: Centrum zdravia R.B.K. s.r.o. Psychiatricka ambulancia
city: Trencin
country: Slovakia
facility: Pro mente sana s.r.o. Psychiaricka ambulancia
city: Pretoria
country: South Africa
facility: Dey Clinic
state: Gauteng
city: Tygervalley
country: South Africa
facility: Cape Trial Centre
state: Western Cape
city: Pretoria
country: South Africa
facility: Denmar Hospital Consulting Rooms
city: Kherson
country: Ukraine
facility: Kherson Regional Psychiatric Hospital
state: Vil Stepanivka
city: Dnipropetrovsk
country: Ukraine
facility: Dnipropetrovsk Regional Clinical Hospital named Mechnikov
city: Donetsk
country: Ukraine
facility: Regional Clinical Psychiatric Hospital, Dept #11
city: Khardov
country: Ukraine
facility: Institute of Neurology, Psychiatry and Narcology, NAMS of Ukraine
city: Simferopol
country: Ukraine
facility: Crimean republican Clinical Psychiatric Hospital
city: Vinnitsia
country: Ukraine
facility: Reg. Psych. Hosp.n.a.O.Yuschenko, Dept #21
Study officials:
affiliation: Sumitomo Pharma America, Inc.
name: Medical Director, MD
role: STUDY_DIRECTOR
References: