Lurasidone Extended Use Study

Schizophrenia Clinical Trial

Official title:

A Long-term, Multicenter, Open-Label, Flexible Dose Continuation Study in Subjects Who Have Completed a Prior Lurasidone Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01485640
• Other study ID #: D1050298
• Secondary ID: 2011-000682-12
• Status: Completed
• Phase: Phase 3
• First received: December 1, 2011
• Last updated: March 12, 2015
• Start date: June 2011
• Est. completion date: February 2014

Study information

• Verified date: March 2015
• Source: Sunovion
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationIndia: Drugs Controller General of IndiaCzech Republic: State Institute for Drug ControlUkraine: Ministry of HealthLithuania: State Medicine Control Agency - Ministry of HealthFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Russia: Ministry of Health of the Russian FederationRomania: National Medicines AgencyColombia: National Institutes of HealthPeru: Ministry of HealthCanada: Health CanadaSouth Africa: Medicines Control CouncilSlovakia: State Institute for Drug Control
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder
• Schizophrenia

Intervention

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

Locations

Country	Name	City	State
Canada	Okanagan Clinical Trials	Kelowna	British Columbia
Colombia	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
Czech Republic	Psychiatricka ambulance	Brno-mesto
Czech Republic	Vojenska nemocnice Olomouc	Olomouc
Czech Republic	Clintrial, s.r.o.	Praha
Czech Republic	Medical Services Prague s.r.o.	Praha
Czech Republic	Psychiatry Trial s.r.o.	Praha
France	Zans Ritter, Marcel	Orvault
France	Hôpital Chalucet, Centre hospitalier intercommunal de Toulon la Seyne sur mer (CHITS)	Toulun
India	Mental Health Treatment Rehabililitation Foundation Dept. of Psychiatry	Ahmedabad	Gujarat
India	Samvedna Hospitals	Ahmedabad	Gujarat
India	Seth K M School of P G Medicine & Research	Ahmedabad	Gujarat
India	Shanti Nursing Home	Aurangabad	Maharashtra
India	Dr. Tambi's Neuropsychiatry Center	Jaipur	Rajaasthan
India	R.K. Yadav Memorial Mental Health & De-Addiction Hospital Psychiatry	Jaipur	Rajasthan
India	Hatkesh Healthcare Foundation	Junagadh	Gujarat
India	Mahendru Psychiatric Centre	Kanpur
India	Brij Psychiatry Hospital & Muskaan Research Centre	Vadodara	Gujarat
India	Vijayawada Institute of Mental Health and Neurosciences	Vijayawada	Andhra Pradesh
India	Brain Mind Behavior Neuroscience Research Institute	Vishakhapatnam	Andh Prad
Lithuania	JSC Neuromeda	Kaunas
Lithuania	Neuromeda JSC	Kaunas
Lithuania	Seskines Outpatient Clinic, Public Institution	Vilnius
Romania	Spitalul Clinic Judetean de Urgenta Cluj	Cluj-Napoca
Romania	Spitalul Clinic de Neuropsihiatrie Craiova	Craiova
Russian Federation	Regional Government Institution (RGI) 'Lipetsk Regional Psychoneurology Hospital'	Lipetsk
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	St. Petersburg State Government Healthcare Institution "City Psychiatric Hospital #4" (St. Petersburg Insane Asylum Distributor)	St. Petersburg
Russian Federation	St. Petersburg State Healthcare Institution (SPbSHI) "City Psychiatric Hospital #6"	St. Petersburg
Serbia	Institute of Mental Health	Belgrade
Serbia	Clinical Centre Nis, Clinic for mental health protection	Nis
Slovakia	Psychiatricka ambulancia Mentum s.r.o.	Bratislava
Slovakia	PsychoLine s.r.o. Psychiatricka ambulancia	Rimavska Sobota
Slovakia	Centrum zdravia R.B.K. s.r.o. Psychiatricka ambulancia	Svidnik
Slovakia	Pro mente sana s.r.o. Psychiaricka ambulancia	Trencin
South Africa	Denmar Hospital Consulting Rooms	Pretoria
South Africa	Dey Clinic	Pretoria	Gauteng
South Africa	Cape Trial Centre	Tygervalley	Western Cape
Ukraine	Dnipropetrovsk Regional Clinical Hospital named Mechnikov	Dnipropetrovsk
Ukraine	Regional Clinical Psychiatric Hospital, Dept #11	Donetsk
Ukraine	Institute of Neurology, Psychiatry and Narcology, NAMS of Ukraine	Khardov
Ukraine	Kherson Regional Psychiatric Hospital	Kherson	Vil Stepanivka
Ukraine	Crimean republican Clinical Psychiatric Hospital	Simferopol
Ukraine	Reg. Psych. Hosp.n.a.O.Yuschenko, Dept #21	Vinnitsia

Sponsors (1)

Lead Sponsor	Collaborator
Sunovion

Countries where clinical trial is conducted

Canada,  Colombia,  Czech Republic,  France,  India,  Lithuania,  Romania,  Russian Federation,  Serbia,  Slovakia,  South Africa,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects With Treatment Emergent AEs, SAEs or Who Discontinued Due to AEs	Primary Safety assessments included spontaneous adverse event (AE) and serious adverse events (SAEs) monitoring.	18 months	Yes
Secondary	Change From Baseline to Month 18 (LOCF) in the Clinical Global Impression Severity Score (CGI-S	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.	18 months	No