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Bipolar DepressionPhase 3NCT00868959

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

A Phase 3 study testing lurasidone in people with Bipolar Depression, run by Sumitomo Pharma America, Inc. at 151 sites in 15 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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 Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Bipolar Depression
What is being tested?
lurasidone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
817 participants
Where
151 sitesin 15 countries
Study dates
Apr 2009to Feb 2013
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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, NCT#00868452 or Study D1050236, NCT#008668699.

Who cannot join

  • 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, NCT#00868452 or D1050236, NCT#008688699).

Trial locations and contacts

151 sites in 15 countries.

151 sites in 15 countries

United States58 sites

  • Albuquerque Neuroscience Inc.

    Albuquerque, New Mexico, 87109

  • Lehigh Valley Hospital

    Allentown, Pennsylvania, 18103

  • South Coast Clinical Trials Inc.

    Anaheim, California, 92804

  • University of Colorado

    Aurora, Colorado, 80045

  • FutureSearch Clinical Trials LP

    Austin, Texas, 78756

  • Quest Therapeutics

    Avon Lake, Ohio, 44012

  • Sheppard Pratt Health System

    Baltimore, Maryland, 21285

  • Florida Clinical Research Center LLC

    Bradenton, Florida, 34208

  • Social Psychiatry Research Institute

    Brooklyn, New York, 11235

  • Neurobehavioral Research, Inc

    Cedarhurst, New York

  • Catalina Research Institute

    Chino, California, 91710

  • Psychiatric Professional Services Inc

    Cincinnati, Ohio, 45267

  • Mood Disorders Program-UHCMC

    Cleveland, Ohio, 44106

  • MetroHealth System

    Cleveland, Ohio, 44122

  • MCB Clinical Research Centers-Colorado Springs

    Colorado Springs, Colorado, 80917

  • Clinical Innovations Inc.

    Costa Mesa, California, 92626

  • FutureSearch Trials

    Dallas, Texas, 75231

  • Pillar Clinical Research LLC

    Dallas, Texas, 75243

  • Midwest Clinical Research Center

    Dayton, Ohio, 45408

  • Synergy Escondido

    Escondido, California, 92025

  • Precise Research Centers

    Flowood, Mississippi, 39232

  • Florida Clinical Research Center LLC

    Fruitland Park, Florida, 34731

  • Collaborative Neuroscience Network Inc

    Garden Grove, California, 92645

  • Red Oak Psychiatry Associates, PA

    Houston, Texas, 77090

  • Accurate Clinical Trials

    Kissimmee, Florida, 34741

  • Lake Charles Clinical Trials LLC

    Lake Charles, Louisiana, 70601

  • Woodland International Research Inc

    Little Rock, Arkansas, 72211

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • Florida Clinical Research Center LLC

    Maitland, California, 32751

  • Clinical Neuroscience Solutions Inc.

    Memphis, Tennessee, 38119

  • Village Clinical Research Inc.

    New York, New York, 10003

  • Medical & Behavioral Health Research PC

    New York, New York, 10023

  • American Medical Research

    Oak Brook, Illinois, 60523

  • Excell Research, Inc

    Oceanside, California, 92056

  • University of California at Irvine Medical Center

    Orange, California, 92868

  • Clinical Neuroscience Solutions INc.

    Orlando, Florida, 32806

  • CNRI - Los Angeles LLC

    Pico Rivera, California, 90660

  • Summit Research Network (Oregon) Inc.

    Portland, Oregon, 97210

  • Zarzar Psychiatric Associates PLLC

    Raleigh, North Carolina, 27607

  • Richard H. Weisler & Associates

    Raleigh, North Carolina, 27609

  • Clinical Innovations Inc.

    Riverside, California, 92506

  • Finger Lakes Clinical Research

    Rochester, New York, 14618

  • Capitol Clinical Research

    Rockville, Maryland, 20852

  • Northwest Behavioral Research Center

    Rosewekk, Georgia, 30076

  • Midwest Research Group

    Saint Charles, Missouri, 63301

  • California Neuropsychopharmacology Clinical Research Instit

    San Diego, California, 92102

  • Artemis Institute for Clinical Research LLC

    San Diego, California, 92123

  • Sharp Mesa Vista Hospital

    San Diego, California, 92123

  • Clinical Innovations Inc.

    Santa Ana, California, 92705

  • Summit Research Network (Seattle) LLC

    Seattle, Washington, 98104

  • Booker, J. Gary, MD. APMC

    Shreveport, Louisiana, 71104

  • Institute for Behavioral Medicine LLC

    Smyrna, Georgia, 30080

  • Stanford University School of Medicine

    Stanford, California, 94305

  • University of South Florida Institute - Tampa

    Tampa, Florida, 33613

  • Collaborative Neuroscience Network Inc.

    Torrance, California, 90502

  • Janus Center for Psychiatric Research

    West Palm Beach, Florida, 33407

  • Wharton Research Center

    Wharton, Texas, 77488

  • CRI Worldwide, LLC

    Willingboro, New Jersey, 08046

Other trials in United States

India21 sites

  • Seth K M School of P G Medicine & Research

    Ahmedabad, Gujarat, 380006

  • Mental Illness Treatment Rehabilitation Foundation (MITR)

    Ahmedabad, Gujarat, 380013

  • Spandana Nursing Home

    Bangalore, Karna, 560010

  • Abhava Hospital

    Bangalore, Karna, 560027

  • Shanti Nursing Home

    Chhatrapati Sambhajinagar, Mahara, 431001

  • Cosmos Hospitals-Delhi Psychiatry Center-Dept. of Psychiatry

    Delhi, National Capital Territory of Delhi, 110092

  • Shree Hatkesh Health Foundation

    Gujarat, 362002

  • Samvedna Hospitals

    Gujarat, 380006

  • Dr. Tambi's Neuropsychiatry Center

    Jaipur, Rajaasthan, 302017

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

    Jaipur, Rajasthan, 302021

  • Mahendru Psychiatric Centre

    Kanpur, Uttar Prad, 208005

  • Manobal Med. Research Centre

    Lucknow, Uttar Prad, 226006

  • Chhatrapati Shahuji Maharaj

    Lucknow, 22603

  • Sujata Dirla Hospital & Research Centre

    Mahara, 422101

  • K.S. Hegde Medical Academy

    Mangalore, Karna, 575018

  • Poona Hospital & Research Center

    Pune, Mahara, 411 030

  • S V Medical College

    Tirupati, Andh Prad, 517507

  • Brij Psychiatry Hospital & Muskaan Research Centre

    Vadodara, Gujarat, 390001

  • Vijayawada Institute of Mental Health and Neurosciences, Psychiatry

    Vijaywada, Andh Prad, 520002

  • Brain Mind Behaviour Neurosciences Research Institute

    Visakhapatnam, Andh Prad, 530002

  • Mahatma Gandhi Institute of Medical Sciences

    Wardha, Mahara, 442001

Other trials in India

Ukraine13 sites

  • Regional Clinical Hospital n.a.l.l.

    Dnipropetrovsk, 49005

  • Com. Inst. "Dnipropetrovsk Reg. Cl. Psych. Hosp." DSMA

    Dnipropetrovsk, 49115

  • Reg. Clin. Psychiatric Hosp. DSMU n.af.M.Gorkiy

    Donetsk, 83037

  • St.In."Inst. of Neurol., Psych. and Narcol. of the AMSU"

    Kharkiv, 61068

  • Kherson Regional Psychiatric Hospital

    Kherson, 73488

  • Kyiv City Psychoneurological Hospital #2

    Kviv, 02660

  • Lviv Reg.St.Cl.Psych.Hosp.Dept.#20, LNMU n.a.D. Halytskiy Chair of Psychiatry, Psychology and Sexololgy

    Lviv, 79021

  • Odesa SMU, based on Odessa Reg. Psychiatric Hosp.#1

    Odesa, 65006

  • Reg. Ci.Ps.H.n.a.O.F.Maltsev, Fem.Ac.Gen.Ps. D.5B,HESIU UM

    Poltava, 36006

  • Crimean republican Clinical Psychiatric Hospital

    Simferopol

  • Ternopil Regional Municipal Dispensary, Narcology Dept., Ch. of Neurol. Psych. Narcol. & Med. Psychol.

    Ternopil, 46020

  • Reg. Psych. Hosp.n.a. O.Yuschenko, Dept. #121 VNMI

    Vinnitsia, 21018

  • Zapor Reg. Cl. Hosp., Zaporizhzhia SMU, ENT Dept.

    Zaporizhzhya, 69032

Other trials in Ukraine

Slovakia8 sites

  • Nemocnica s poliklinikou Prievidza so sidlom v Bojniciach Psychiatricke oddelenie

    Bojnice, 92701

  • Psychiatricka ambulancia Mentum, s.r.o.

    Bratislava, 82007

  • Univerzitna nemocnica Bratislava, Nemocnica Ruzinov Psychiatricka klinika

    Bratislava, 82606

  • Nemocnica s poliklinikou Liptovsky Mikulas Psychiatricke oddelenie

    Liptovský Mikuláš, 03123

  • PsychoLine s.r.o. Psychiatricka ambulancia

    Rimavská Sobota, 97901

  • Nemocnica s poliklinikou sv Barbory Roznava a.s. Psychiatricke oddelenie

    Rožňava, 048 01

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

    Svidník, 08901

  • Pro mente sana s.r.o. Psychiaricka ambulancia

    Trenčín, 91101

Other trials in Slovakia

Czechia7 sites

  • Saint Anne, s.r.o., Psychiatricke oddeleni

    Brno - Mesto, 602 00

  • BIALBI s.r.o. Psychiatricke oddeleni

    Litoměřice, 412 01

  • Psychiatricka ambulance Prosek

    Lovosicka

  • Vojenska nemocnice Olomouc

    Olomouc, 779 00

  • Clintrial, s.r.o.

    Prague, 10 100 00

  • Psychiatry Trial s.r.o.

    Prague, 158 00

  • Medical Services Prague s.r.o.

    Prague, 6 160 00

Other trials in Czechia

Japan6 sites

  • Ongata Hospital

    Hachioji-shi, 192-0153

  • Kohnodai Hp., National Center for Global Health and Medicine

    Ichikawa-sha, 272-8516

  • NHO Hizen Psychiatric Center

    Kanzaki-gun, 842-0192

  • National Center of Neurology and Psychiatry

    Kodaira-shi, 187-8551

  • Asakayama General Hospital

    Sakaishi, 590-0018

  • Osaka Institute of Clinical Psychiatry Shin-abuyama Hospital

    Takatsuki-shi, 569-1041

Other trials in Japan

Romania6 sites

  • Spitalul Clinic de Urgenta Militar Central

    Bucharest, 010825

  • Spitalul Clinic de Psihaiatrie Prof. Dr. Alexandru Obregia

    Bucharest, 041914

  • Spitalul Clinic Judetean de Urgenta Cluj

    Cluj-Napoca, 400012

  • Spitalul Clinic de Neuropsihiatrie Craiova

    Craiova, 200620

  • Centrul de Recuperare si Reabilitare Gura Ocnitei

    Gura Ocniței, 130083

  • Spitalul Clinic de Neurologie si Psihiatrie Oradea

    Oradea, 410154

Other trials in Romania

Russia6 sites

  • Russian State Medical University of RosZdrav

    Moscow, 117997

  • Moscow Medical Academy name I.M. Sechenov

    Moscow, 11935

  • City Psychiatric Hospital #2 of St. Nikolay Chudotvorets

    Saint Petersburg, 190121

  • Bekhterev Scientific Research Psychoneurological Institute

    Saint Petersburg, 193019

  • Psychoneurology Dispensary #4

    Saint Petersburg, 197110

  • LLC International Medical Centre "SOGAZ"

    Saint Petersburg, 198035

Other trials in Russia

South Africa6 sites

  • Groote Schuur Hospital

    Cape Town, 7925

  • Cape Trial Centre

    Cape Town, W. Cape, 7530

  • Paarl Medical Centre

    Paarl, W. Cape, 7646

  • Clinika, Murray and Roberts Building

    Port Elizabeth, 6000

  • Dey Clinic

    Pretoria, Gauteng, 0181

  • Vereeniging Medi-Clinic

    Vereeniging, Free State, 1941

Other trials in South Africa

Lithuania5 sites

  • Neuromeda, JSC

    Kaunas, 50185

  • Kaunas Hospital Division Marui Hospital, Public Institution

    Kaunas, 53136

  • Silutes Mental Health and Psychotherapy Center, JSC

    Šilutė, 99142

  • Seskines Outpatient Clinic, Public Institution

    Vilnius, 07156

  • Zirmunai Mental Health Center, Public Institution

    Vilnius, 09112

Other trials in Lithuania

Canada4 sites

  • Clinical Research Group Edmonton

    Edmonton, Alberta, T6L 6W6

  • Pierre-Janet Hospital

    Gatineau, Quebec, J9A 1K7

  • Okanagan Clinical Trials

    Kelowna, British Columbia, V1Y 2H4

  • Hopital Louis-H Lafontaine

    Montreal, Quebec, H1N 3M5

Other trials in Canada

Colombia4 sites

  • Centro de Investigaciones y Proyectos en Neurociencias CIPNA Investigations

    Barranquilla

  • E.S.E. Hospital Mental de Antioquia

    Bello

  • Centro de Investigacion y Atencion para la Salud Mental

    Bogotá

  • Centro de Investigaciones del Sistema Nerviosa Limitada-Gr

    Bogotá

Other trials in Colombia

Peru3 sites

  • Hospital Nacional Hipolito Unanue

    Lima, 10

  • Hospital Nacional Arzobispo Loayza

    Lima, 1

  • Clinica Vesalio

    Lima, 41

Other trials in Peru

France2 sites

  • Hopital Caremeau, Service de Psychiatrie A

    Nîmes, 30 30029

  • Zans Ritter, Marcel

    Orvault, 44700

Other trials in France

Poland2 sites

  • ZOZ Poradnia Zdrowia Psychicznego

    Chełmno, 86-200

  • Praktyka Lekarska Sensorium S.M.O.

    Skorzewo, 60-185

Other trials in Poland

About this study

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

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

Being tested
lurasidone
Keywords
Bipolar, Depression, Lurasidone, Latuda
Medical subject headings
Bipolar Disorder, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • lurasidoneDrug

    Lurasidone 20-120 mg/d Flexibly Dosed - 24 weeks

Study groups in NCT00868959
Study groupRoleWhat they receive
lurasidoneExperimentalNot described
Receives: Drug: lurasidone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: 24 weeks

Secondary outcomes (2)

  1. 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.

    Measured: 24 weeks

  2. 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.

    Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2009 (estimated)
  2. Study startApr 2009
  3. Primary completionFeb 2013
  4. Study completionFeb 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
817 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00868959
Sponsor's protocol ID
D1050256
Other IDs
EUDRACT No. 2008-007483-42
Status last verified
Mar 2016
First submitted
23 Mar 2009
Last updated
14 Apr 2016
Data monitoring committee
Yes

Publications

  • Forester BP, Sajatovic M, Tsai J, Pikalov A, Cucchiaro J, Loebel A. Safety and Effectiveness of Long-Term Treatment with Lurasidone in Older Adults with Bipolar Depression: Post-Hoc Analysis of a 6-Month, Open-Label Study. Am J Geriatr Psychiatry. 2018 Feb;26(2):150-159. doi: 10.1016/j.jagp.2017.08.013. Epub 2017 Oct 10.

    PubMed 29146409

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing lurasidone in people with Bipolar Depression, run by Sumitomo Pharma America, Inc. at 151 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 151 sites in United States, India, Ukraine, Slovakia, Czechia and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Serious and Non-serious Treatment-emergent Adverse Events Who Have Completed 24 Weeks of Extension Study Treatment (time frame: 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00868959, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2016.

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