Lurasidone - A 24-week Extension Study of Patients With Bipolar I Depression

Bipolar Depression Clinical Trial

Official title:

A 24-Week, Flexible-Dose, Open-Label Extension Study of Lurasidone for the Treatment of Bipolar I Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00868959
• Other study ID #: D1050256
• Secondary ID: EUDRACT No. 2008
• Status: Completed
• Phase: Phase 3
• First received: March 23, 2009
• Last updated: April 9, 2014
• Start date: April 2009
• Est. completion date: February 2013

Study information

• Verified date: April 2014
• Source: Sunovion
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCzech Republic: State Institute for Drug ControlFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)India: Drugs Controller General of IndiaPoland: Ministry of HealthRomania: National Medicines AgencyRussia: Ministry of Health of the Russian FederationSouth Africa: Medicines Control CouncilUkraine: Ministry of HealthCanada: Health CanadaColombia: National Institutes of HealthPeru: Ministry of HealthLithuania: State Medicine Control Agency - Ministry of HealthJapan: Pharmaceuticals and Medical Devices AgencySlovakia: State Institute for Drug ControlGermany: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

This clinical study is designed to test the hypothesis that lurasidone is effective, tolerable, and safe for the treatment of patients with bipolar I depression

Recruitment information / eligibility

• Status: Completed
• Enrollment: 813
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Subject is judged by the investigator to be suitable for participation in a 24-week clinical trial involving open-label lurasidone treatment

• Subject has completed the 6-week treatment period and all required assessments on the final study visit (Day 42, Visit 8) of either Study D1050235 or Study D1050236

Exclusion Criteria:

• Imminent risk of suicide, injury to self or to others, or damage to property

• Subject has evidence of severe movement disorders.

• Subject tests positive for drugs of abuse (at Visit 8 in Study D1050235 or D1050236)

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Depression
• Depression
• Depressive Disorder

Intervention

Drug:
• lurasidone
Lurasidone 20-120 mg/d Flexibly Dosed - 24 weeks

Locations

Country	Name	City	State
Canada	Clinical Research Group Edmonton	Edmonton	Alberta
Canada	Pierre-Janet Hospital	Gatineau	Quebec
Canada	Okanagan Clinical Trials	Kelowna	British Columbia
Canada	Hopital Louis-H Lafontaine	Montreal	Quebec
Colombia	Centro de Investigaciones y Proyectos en Neurociencias CIPNA Investigations	Barranquilla
Colombia	E.S.E. Hospital Mental de Antioquia	Bello
Colombia	Centro de Investigacion y Atencion para la Salud Mental	Bogota
Colombia	Centro de Investigaciones del Sistema Nerviosa Limitada-Gr	Bogota
Czech Republic	Saint Anne, s.r.o., Psychiatricke oddeleni	Brno - mesto
Czech Republic	BIALBI s.r.o. Psychiatricke oddeleni	Litomerice
Czech Republic	Psychiatricka ambulance Prosek	Lovosicka
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	Hopital Caremeau, Service de Psychiatrie A	Nimes Cedex
France	Zans Ritter, Marcel	Orvault
India	Mental Illness Treatment Rehabilitation Foundation (MITR)	Ahmedabad	Gujarat
India	Seth K M School of P G Medicine & Research	Ahmedabad	Gujarat
India	Shanti Nursing Home	Aurangabad	Mahara
India	Abhava Hospital	Bangalore	Karna
India	Spandana Nursing Home	Bangalore	Karna
India	Cosmos Hospitals-Delhi Psychiatry Center-Dept. of Psychiatry	Delhi
India	Samvedna Hospitals	Gujarat
India	Shree Hatkesh Health Foundation	Gujarat
India	Dr. Tambi's Neuropsychiatry Center	Jaipur	Rajaasthan
India	R.K. Yadav Memorial Mental Health & De-Addiction Hospital Psychiatry	Jaipur	Rajasthan
India	Mahendru Psychiatric Centre	Kanpur	Uttar Prad
India	Chhatrapati Shahuji Maharaj	Lucknow
India	Manobal Med. Research Centre	Lucknow	Uttar Prad
India	Sujata Dirla Hospital & Research Centre	Mahara
India	K.S. Hegde Medical Academy	Mangalore	Karna
India	Poona Hospital & Research Center	Pune	Mahara
India	S V Medical College	Tirupati	Andh Prad
India	Brij Psychiatry Hospital & Muskaan Research Centre	Vadodara	Gujarat
India	Vijayawada Institute of Mental Health and Neurosciences, Psychiatry	Vijaywada	Andh Prad
India	Brain Mind Behaviour Neurosciences Research Institute	Vishakhapatnam	Andh Prad
India	Mahatma Gandhi Institute of Medical Sciences	Wardha	Mahara
Japan	Ongata Hospital	Hachioji-shi
Japan	Kohnodai Hp., National Center for Global Health and Medicine	Ichikawa-sha
Japan	NHO Hizen Psychiatric Center	Kanzaki-gun
Japan	National Center of Neurology and Psychiatry	Kodaira-shi
Japan	Asakayama General Hospital	Sakai-shi
Japan	Osaka Institute of Clinical Psychiatry Shin-abuyama Hospital	Takatsuki-shi
Lithuania	Kaunas Hospital Division Marui Hospital, Public Institution	Kaunas
Lithuania	Neuromeda, JSC	Kaunas
Lithuania	Silutes Mental Health and Psychotherapy Center, JSC	Silute
Lithuania	Seskines Outpatient Clinic, Public Institution	Vilnius
Lithuania	Zirmunai Mental Health Center, Public Institution	Vilnius
Peru	Clinica Vesalio	Lima
Peru	Hospital Nacional Arzobispo Loayza	Lima
Peru	Hospital Nacional Hipolito Unanue	Lima
Poland	ZOZ Poradnia Zdrowia Psychicznego	Chelmno
Poland	Praktyka Lekarska Sensorium S.M.O.	Skorzewo
Romania	Spitalul Clinic de Psihaiatrie Prof. Dr. Alexandru Obregia	Bucuresti
Romania	Spitalul Clinic de Urgenta Militar Central	Bucuresti
Romania	Spitalul Clinic Judetean de Urgenta Cluj	Cluj-Napoca
Romania	Spitalul Clinic de Neuropsihiatrie Craiova	Craiova
Romania	Centrul de Recuperare si Reabilitare Gura Ocnitei	Gura Ocnitei
Romania	Spitalul Clinic de Neurologie si Psihiatrie Oradea	Oradea
Russian Federation	Moscow Medical Academy name I.M. Sechenov	Moscow
Russian Federation	Russian State Medical University of RosZdrav	Moscow
Russian Federation	Bekhterev Scientific Research Psychoneurological Institute	St. Petersburg
Russian Federation	City Psychiatric Hospital #2 of St. Nikolay Chudotvorets	St. Petersburg
Russian Federation	LLC International Medical Centre "SOGAZ"	St. Petersburg
Russian Federation	Psychoneurology Dispensary #4	St. Petersburg
Slovakia	Nemocnica s poliklinikou Prievidza so sidlom v Bojniciach Psychiatricke oddelenie	Bojnice
Slovakia	Psychiatricka ambulancia Mentum, s.r.o.	Bratislava
Slovakia	Univerzitna nemocnica Bratislava, Nemocnica Ruzinov Psychiatricka klinika	Bratislava
Slovakia	Nemocnica s poliklinikou Liptovsky Mikulas Psychiatricke oddelenie	Liptovsky Mikulas
Slovakia	PsychoLine s.r.o. Psychiatricka ambulancia	Rimavska Sobota
Slovakia	Nemocnica s poliklinikou sv Barbory Roznava a.s. Psychiatricke oddelenie	Roznava
Slovakia	Centrum zdravia R. B.K. s.r.o. Psychiatricka ambulancia	Svidnik
Slovakia	Pro mente sana s.r.o. Psychiaricka ambulancia	Trencin
South Africa	Groote Schuur Hospital	Cape Town
South Africa	Cape Trial Centre	Cape Town, W. Cape
South Africa	Paarl Medical Centre	Paarl, W. Cape
South Africa	Clinika, Murray and Roberts Building	Port Elizabeth
South Africa	Dey Clinic	Pretoria, Gauteng
South Africa	Vereeniging Medi-Clinic	Vereeniging, Free State
Ukraine	Com. Inst. "Dnipropetrovsk Reg. Cl. Psych. Hosp." DSMA	Dnipropetrovsk
Ukraine	Regional Clinical Hospital n.a.l.l.	Dnipropetrovsk
Ukraine	Reg. Clin. Psychiatric Hosp. DSMU n.af.M.Gorkiy	Donetsk
Ukraine	St.In."Inst. of Neurol., Psych. and Narcol. of the AMSU"	Kharkiv
Ukraine	Kherson Regional Psychiatric Hospital	Kherson
Ukraine	Kyiv City Psychoneurological Hospital #2	Kviv
Ukraine	Lviv Reg.St.Cl.Psych.Hosp.Dept.#20, LNMU n.a.D. Halytskiy Chair of Psychiatry, Psychology and Sexololgy	Lviv
Ukraine	Odesa SMU, based on Odessa Reg. Psychiatric Hosp.#1	Odessa
Ukraine	Reg. Ci.Ps.H.n.a.O.F.Maltsev, Fem.Ac.Gen.Ps. D.5B,HESIU UM	Poltava
Ukraine	Crimean republican Clinical Psychiatric Hospital	Simferopol
Ukraine	Ternopil Regional Municipal Dispensary, Narcology Dept., Ch. of Neurol. Psych. Narcol. & Med. Psychol.	Ternopil
Ukraine	Reg. Psych. Hosp.n.a. O.Yuschenko, Dept. #121 VNMI	Vinnitsia
Ukraine	Zapor Reg. Cl. Hosp., Zaporizhzhia SMU, ENT Dept.	Zaporizhzhia
United States	Albuquerque Neuroscience Inc.	Albuquerque	New Mexico
United States	Lehigh Valley Hospital	Allentown	Pennsylvania
United States	South Coast Clinical Trials Inc.	Anaheim	California
United States	University of Colorado	Aurora	Colorado
United States	FutureSearch Clinical Trials LP	Austin	Texas
United States	Quest Therapeutics	Avon Lake	Ohio
United States	Sheppard Pratt Health System	Baltimore	Maryland
United States	Florida Clinical Research Center LLC	Bradenton	Florida
United States	Social Psychiatry Research Institute	Brooklyn	New York
United States	Neurobehavioral Research, Inc	Cedarhurst	New York
United States	Catalina Research Institute	Chino	California
United States	Psychiatric Professional Services Inc	Cincinnati	Ohio
United States	MetroHealth System	Cleveland	Ohio
United States	Mood Disorders Program-UHCMC	Cleveland	Ohio
United States	MCB Clinical Research Centers-Colorado Springs	Colorado Springs	Colorado
United States	Clinical Innovations Inc.	Costa Mesa	California
United States	FutureSearch Trials	Dallas	Texas
United States	Pillar Clinical Research LLC	Dallas	Texas
United States	Midwest Clinical Research Center	Dayton	Ohio
United States	Synergy Escondido	Escondido	California
United States	Precise Research Centers	Flowood	Mississippi
United States	Florida Clinical Research Center LLC	Fruitland park	Florida
United States	Collaborative Neuroscience Network Inc	Garden Grove	California
United States	Red Oak Psychiatry Associates, PA	Houston	Texas
United States	Accurate Clinical Trials	Kissimmee	Florida
United States	Lake Charles Clinical Trials LLC	Lake Charles	Louisiana
United States	Woodland International Research Inc	Little Rock	Arkansas
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	Florida Clinical Research Center LLC	Maitland	California
United States	Clinical Neuroscience Solutions Inc.	Memphis	Tennessee
United States	Medical & Behavioral Health Research PC	New York	New York
United States	Village Clinical Research Inc.	New York	New York
United States	American Medical Research	Oak Brook	Illinois
United States	Excell Research, Inc	Oceanside	California
United States	University of California at Irvine Medical Center	Orange	California
United States	Clinical Neuroscience Solutions INc.	Orlando	Florida
United States	CNRI - Los Angeles LLC	Pico Rivera	California
United States	Summit Research Network (Oregon) Inc.	Portland	Oregon
United States	Richard H. Weisler & Associates	Raleigh	North Carolina
United States	Zarzar Psychiatric Associates PLLC	Raleigh	North Carolina
United States	Clinical Innovations Inc.	Riverside	California
United States	Finger Lakes Clinical Research	Rochester	New York
United States	Capitol Clinical Research	Rockville	Maryland
United States	Northwest Behavioral Research Center	Rosewekk	Georgia
United States	Artemis Institute for Clinical Research LLC	San Diego	California
United States	California Neuropsychopharmacology Clinical Research Instit	San Diego	California
United States	Sharp Mesa Vista Hospital	San Diego	California
United States	Clinical Innovations Inc.	Santa Ana	California
United States	Summit Research Network (Seattle) LLC	Seattle	Washington
United States	Booker, J. Gary, MD. APMC	Shreveport	Louisiana
United States	Institute for Behavioral Medicine LLC	Smyrna	Georgia
United States	Midwest Research Group	St. Charles	Missouri
United States	Stanford University School of Medicine	Stanford	California
United States	University of South Florida Institute - Tampa	Tampa	Florida
United States	Collaborative Neuroscience Network Inc.	Torrance	California
United States	Janus Center for Psychiatric Research	West Palm Beach	Florida
United States	Wharton Research Center	Wharton	Texas
United States	CRI Worldwide, LLC	Willingboro	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Sunovion

Countries where clinical trial is conducted

United States,  Canada,  Colombia,  Czech Republic,  France,  India,  Japan,  Lithuania,  Peru,  Poland,  Romania,  Russian Federation,  Slovakia,  South Africa,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Serious and Non-serious Treatment-emergent Adverse Events Who Have Completed 24 Weeks of Extension Study Treatment	Rate of treatment-emergent adverse events in subjects who have completed (ie, reached 6-week endpoint) of Study D1050235 (NCT00868452), Study D1050236 (NCT00868699) or Study D1050292 (NCT01284517)	24 weeks	Yes
Secondary	Change From Open-label Extension Baseline to Week 24 (Month 6/LOCF Endpoint) in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score	The MADRS is a clinician-rated assessment of the subject's level of depression. Ten items are rated on a Likert scale, from 0="Normal" to 6="Most Severe". The MADRS total score is calculated as the sum of ten items: reported sadness, apparent sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. The MADRS total score ranges from 0 to 60. Higher scores are associated with greater severity.	24 weeks	No
Secondary	Change From Open-label Extension Baseline to Week 24 (Month 6/LOCF Endpoint) in Clinical Global Impressions Bipolar Version, Severity of Illness (CGI-BP-S) Score (Depression)	This CGI-BP-S is a clinician-rated assessment of the subjects current severity of depression and ranges from 1="Normal, not ill" to 7="Very severly ill". Higher scores are associated with greater severity.	24 weeks	No