Lurasidone Extended Use Study

NCT01485640 | Completed Phase 3 Results

• 2 other identifiers: D10502982011-000682-12
• Study Type: interventional
• Target: 162
• Locations: 12 countries
• Sites: 46

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.

Conditions

Schizophrenia; Bipolar Disorder

Keywords

Schizophrenia; bipolar disorder; Lurasidone; Latuda

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

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

  18 months

Study Arms (1)

Lurasidone

EXPERIMENTAL

Lurasidone flexibly dosed

Drug: Lurasidone

Interventions

Lurasidone DRUG

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

Lurasidone

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Sumitomo Pharma America, Inc.: lead

Study Sites (46)

Okanagan Clinical Trials

Kelowna, British Columbia, V1Y 1Z9, Canada

Location

Centro de Investigaciones y Proyectos en Neurociencias CIPNA Investigations

Barranquilla, Colombia

Location

E.S.E. Hospital Mental de Antioquia

Bello, Colombia

Location

CISNE - UIC Campo Abierto

Bogotá, Colombia

Location

Psychiatricka ambulance

Brno-mesto, 602 00, Czechia

Location

Vojenska nemocnice Olomouc

Olomouc, 711 11, Czechia

Location

Clintrial, s.r.o.

Prague, 10 100 00, Czechia

Location

Psychiatry Trial s.r.o.

Prague, 158 00, Czechia

Location

Medical Services Prague s.r.o.

Prague, 6 160 00, Czechia

Location

Zans Ritter, Marcel

Orvault, 44700, France

Location

Hôpital Chalucet, Centre hospitalier intercommunal de Toulon la Seyne sur mer (CHITS)

Toulun, 83000, France

Location

Brain Mind Behavior Neuroscience Research Institute

Visakhapatnam, Andh Prad, 530002, India

Location

Vijayawada Institute of Mental Health and Neurosciences

Vijayawada, Andhra Pradesh, 520002, India

Location

Samvedna Hospitals

Ahmedabad, Gujarat, 380006, India

Location

Seth K M School of P G Medicine & Research

Ahmedabad, Gujarat, 380006, India

Location

Mental Health Treatment Rehabililitation Foundation Dept. of Psychiatry

Ahmedabad, Gujarat, 380013, India

Location

Hatkesh Healthcare Foundation

Jūnāgadh, Gujarat, 362001, India

Location

Brij Psychiatry Hospital & Muskaan Research Centre

Vadodara, Gujarat, 390001, India

Location

Shanti Nursing Home

Aurangabad, Maharashtra, 431005, India

Location

Dr. Tambi's Neuropsychiatry Center

Jaipur, Rajaasthan, 302017, India

Location

R.K. Yadav Memorial Mental Health & De-Addiction Hospital Psychiatry

Jaipur, Rajasthan, 302021, India

Location

Mahendru Psychiatric Centre

Kanpur, 208005, India

Location

Neuromeda JSC

Kaunas, 50185, Lithuania

Location

JSC Neuromeda

Kaunas, LT-50185, Lithuania

Location

Seskines Outpatient Clinic, Public Institution

Vilnius, 07156, Lithuania

Location

Spitalul Clinic Judetean de Urgenta Cluj

Cluj-Napoca, 400012, Romania

Location

Spitalul Clinic de Neuropsihiatrie Craiova

Craiova, 200620, Romania

Location

Regional Government Institution (RGI) 'Lipetsk Regional Psychoneurology Hospital'

Lipetsk, 398007, Russia

Location

St. Petersburg State Budgetary Healthcare Institution 'City Psychoneurology Dispensary #7 (with In-Patient Department)', (SPb SBHI "CPNDD-7"), at Daycare Facility #1

Saint Petersburg, 19005, Russia

Location

St. Petersburg State Government Healthcare Institution "City Psychiatric Hospital #4" (St. Petersburg Insane Asylum Distributor)

Saint Petersburg, 191119, Russia

Location

St. Petersburg State Healthcare Institution (SPbSHI) "City Psychiatric Hospital #6"

Saint Petersburg, 191167, Russia

Location

Institute of Mental Health

Belgrade, 11000, Serbia

Location

Clinical Centre Nis, Clinic for mental health protection

Niš, 18000, Serbia

Location

Psychiatricka ambulancia Mentum s.r.o.

Bratislava, 82007, Slovakia

Location

PsychoLine s.r.o. Psychiatricka ambulancia

Rimavská Sobota, 97901, Slovakia

Location

Centrum zdravia R.B.K. s.r.o. Psychiatricka ambulancia

Svidník, 08901, Slovakia

Location

Pro mente sana s.r.o. Psychiaricka ambulancia

Trenčín, 91101, Slovakia

Location

Dey Clinic

Pretoria, Gauteng, 181, South Africa

Location

Cape Trial Centre

Tygervalley, Western Cape, 7530, South Africa

Location

Denmar Hospital Consulting Rooms

Pretoria, 0081, South Africa

Location

Kherson Regional Psychiatric Hospital

Kherson, Vil Stepanivka, 73488, Ukraine

Location

Dnipropetrovsk Regional Clinical Hospital named Mechnikov

Dnipropetrovsk, 49005, Ukraine

Location

Regional Clinical Psychiatric Hospital, Dept #11

Donetsk, 83037, Ukraine

Location

Institute of Neurology, Psychiatry and Narcology, NAMS of Ukraine

Khardov, 61068, Ukraine

Location

Crimean republican Clinical Psychiatric Hospital

Simferopol, Ukraine

Location

Reg. Psych. Hosp.n.a.O.Yuschenko, Dept #21

Vinnitsia, 21018, Ukraine

Location

MeSH Terms

Conditions

Schizophrenia; Bipolar Disorder

Interventions

Lurasidone Hydrochloride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Medical Director
• Organization: Sunovion

clinicaltrialdisclosure@sunvion.com

1-866-503-6351

Study Officials

• Medical Director, MD

  Sumitomo Pharma America, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2011
• First Posted: December 5, 2011
• Study Start: June 1, 2011
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: November 4, 2016
• Results First Posted: March 11, 2015

Record last verified: 2016-09

Locations

RU (4); ZA (3); UA (6); CZ (5); LI (3); RO (2); CA (1); SE (2); SL (4); CO (3); IN (11); FR (2)