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

March 15, 2016 updated by: Sunovion

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

817

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6L 6W6
        • Clinical Research Group Edmonton
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 2H4
        • Okanagan Clinical Trials
    • Quebec
      • Gatineau, Quebec, Canada, J9A 1K7
        • Pierre-Janet Hospital
      • Montreal, Quebec, Canada, H1N 3M5
        • Hopital Louis-H Lafontaine
  • Colombia
      • Barranquilla, Colombia
        • Centro de Investigaciones y Proyectos en Neurociencias CIPNA Investigations
      • Bello, Colombia
        • E.S.E. Hospital Mental de Antioquia
      • Bogota, Colombia
        • Centro de Investigación y Atención para la Salud Mental
      • Bogota, Colombia
        • Centro de Investigaciones del Sistema Nerviosa Limitada-Gr
  • Czech Republic
      • Brno - mesto, Czech Republic, 602 00
        • Saint Anne, s.r.o., Psychiatricke oddeleni
      • Litomerice, Czech Republic, 412 01
        • BIALBI s.r.o. Psychiatricke oddeleni
      • Lovosicka, Czech Republic
        • Psychiatricka ambulance Prosek
      • Olomouc, Czech Republic, 779 00
        • Vojenska nemocnice Olomouc
      • Praha, Czech Republic, 10 100 00
        • CLINTRIAL, s.r.o.
      • Praha, Czech Republic, 158 00
        • Psychiatry Trial s.r.o.
      • Praha, Czech Republic, 6 160 00
        • Medical Services Prague s.r.o.
  • France
      • Nimes Cedex, France, 30 30029
        • Hopital Caremeau, Service de Psychiatrie A
      • Orvault, France, 44700
        • Zans Ritter, Marcel
  • India
      • Delhi, India, 110092
        • Cosmos Hospitals-Delhi Psychiatry Center-Dept. of Psychiatry
      • Gujarat, India, 362002
        • Shree Hatkesh Health Foundation
      • Gujarat, India, 380006
        • Samvedna Hospitals
      • Lucknow, India, 22603
        • Chhatrapati Shahuji Maharaj
      • Mahara, India, 422101
        • Sujata Dirla Hospital & Research Centre
    • Andh Prad
      • Tirupati, Andh Prad, India, 517507
        • S V Medical College
      • Vijaywada, Andh Prad, India, 520002
        • Vijayawada Institute of Mental Health and Neurosciences, Psychiatry
      • Vishakhapatnam, Andh Prad, India, 530002
        • Brain Mind Behaviour Neurosciences Research Institute
    • Gujarat
      • Ahmedabad, Gujarat, India, 380013
        • Mental Illness Treatment Rehabilitation Foundation (MITR)
      • Ahmedabad, Gujarat, India, 380006
        • Seth K M School of P G Medicine & Research
      • Vadodara, Gujarat, India, 390001
        • Brij Psychiatry Hospital & Muskaan Research Centre
    • Karna
      • Bangalore, Karna, India, 560010
        • Spandana Nursing Home
      • Bangalore, Karna, India, 560027
        • Abhava Hospital
      • Mangalore, Karna, India, 575018
        • K.S. Hegde Medical Academy
    • Mahara
      • Aurangabad, Mahara, India, 431001
        • Shanti Nursing Home
      • Pune, Mahara, India, 411 030
        • Poona Hospital & Research Center
      • Wardha, Mahara, India, 442001
        • Mahatma Gandhi Institute of Medical Sciences
    • Rajaasthan
      • Jaipur, Rajaasthan, India, 302017
        • Dr. Tambi's Neuropsychiatry Center
    • Rajasthan
      • Jaipur, Rajasthan, India, 302021
        • R.K. Yadav Memorial Mental Health & De-Addiction Hospital Psychiatry
    • Uttar Prad
      • Kanpur, Uttar Prad, India, 208005
        • Mahendru Psychiatric Centre
      • Lucknow, Uttar Prad, India, 226006
        • Manobal Med. Research Centre
  • Japan
      • Hachioji-shi, Japan, 192-0153
        • Ongata Hospital
      • Ichikawa-sha, Japan, 272-8516
        • Kohnodai Hp., National Center for Global Health and Medicine
      • Kanzaki-gun, Japan, 842-0192
        • NHO Hizen Psychiatric Center
      • Kodaira-shi, Japan, 187-8551
        • National Center of Neurology and Psychiatry
      • Sakai-shi, Japan, 590-0018
        • Asakayama General Hospital
      • Takatsuki-shi, Japan, 569-1041
        • Osaka Institute of Clinical Psychiatry Shin-Abuyama Hospital
  • Lithuania
      • Kaunas, Lithuania, 50185
        • Neuromeda, JSC
      • Kaunas, Lithuania, 53136
        • Kaunas Hospital Division Marui Hospital, Public Institution
      • Silute, Lithuania, 99142
        • Silutes Mental Health and Psychotherapy Center, JSC
      • Vilnius, Lithuania, 07156
        • Seskines Outpatient Clinic, Public Institution
      • Vilnius, Lithuania, 09112
        • Zirmunai Mental Health Center, Public Institution
  • Peru
      • Lima, Peru, 41
        • Clinica Vesalio
      • Lima, Peru, 10
        • Hospital Nacional Hipólito Unanue
      • Lima, Peru, 1
        • Hospital Nacional Arzobispo Loayza
  • Poland
      • Chelmno, Poland, 86-200
        • ZOZ Poradnia Zdrowia Psychicznego
      • Skorzewo, Poland, 60-185
        • Praktyka Lekarska Sensorium S.M.O.
  • Romania
      • Bucuresti, Romania, 041914
        • Spitalul Clinic de Psihaiatrie Prof. Dr. Alexandru Obregia
      • Bucuresti, Romania, 010825
        • Spitalul Clinic de Urgenta Militar Central
      • Cluj-Napoca, Romania, 400012
        • Spitalul Clinic Judetean de Urgenta Cluj
      • Craiova, Romania, 200620
        • Spitalul Clinic de Neuropsihiatrie Craiova
      • Gura Ocnitei, Romania, 130083
        • Centrul de Recuperare si Reabilitare Gura Ocnitei
      • Oradea, Romania, 410154
        • Spitalul Clinic de Neurologie si Psihiatrie Oradea
  • Russian Federation
      • Moscow, Russian Federation, 117997
        • Russian State Medical University of RosZdrav
      • Moscow, Russian Federation, 11935
        • Moscow Medical Academy name I.M. Sechenov
      • St. Petersburg, Russian Federation, 190121
        • City Psychiatric Hospital #2 of St. Nikolay Chudotvorets
      • St. Petersburg, Russian Federation, 193019
        • Bekhterev Scientific Research Psychoneurological Institute
      • St. Petersburg, Russian Federation, 197110
        • Psychoneurology Dispensary #4
      • St. Petersburg, Russian Federation, 198035
        • LLC International Medical Centre "SOGAZ"
  • Slovakia
      • Bojnice, Slovakia, 92701
        • Nemocnica s poliklinikou Prievidza so sidlom v Bojniciach Psychiatricke oddelenie
      • Bratislava, Slovakia, 82007
        • Psychiatricka ambulancia Mentum, s.r.o.
      • Bratislava, Slovakia, 82606
        • Univerzitna nemocnica Bratislava, Nemocnica Ruzinov Psychiatricka klinika
      • Liptovsky Mikulas, Slovakia, 03123
        • Nemocnica s poliklinikou Liptovsky Mikulas Psychiatricke oddelenie
      • Rimavska Sobota, Slovakia, 97901
        • PsychoLine s.r.o. Psychiatricka ambulancia
      • Roznava, Slovakia, 048 01
        • Nemocnica s poliklinikou sv Barbory Roznava a.s. Psychiatricke oddelenie
      • Svidnik, Slovakia, 08901
        • Centrum zdravia R. B.K. s.r.o. Psychiatricka ambulancia
      • Trencin, Slovakia, 91101
        • Pro mente sana s.r.o. Psychiaricka ambulancia
  • South Africa
      • Cape Town, South Africa, 7925
        • Groote Schuur Hospital
      • Cape Town, W. Cape, South Africa, 7530
        • Cape Trial Centre
      • Paarl, W. Cape, South Africa, 7646
        • Paarl Medical Centre
      • Port Elizabeth, South Africa, 6000
        • Clinika, Murray and Roberts Building
      • Pretoria, Gauteng, South Africa, 0181
        • Dey Clinic
      • Vereeniging, Free State, South Africa, 1941
        • Vereeniging Medi-Clinic
  • Ukraine
      • Dnipropetrovsk, Ukraine, 49005
        • Regional Clinical Hospital n.a.l.l.
      • Dnipropetrovsk, Ukraine, 49115
        • Com. Inst. "Dnipropetrovsk Reg. Cl. Psych. Hosp." DSMA
      • Donetsk, Ukraine, 83037
        • Reg. Clin. Psychiatric Hosp. DSMU n.af.M.Gorkiy
      • Kharkiv, Ukraine, 61068
        • St.In."Inst. of Neurol., Psych. and Narcol. of the AMSU"
      • Kherson, Ukraine, 73488
        • Kherson Regional Psychiatric Hospital
      • Kviv, Ukraine, 02660
        • Kyiv City Psychoneurological Hospital #2
      • Lviv, Ukraine, 79021
        • Lviv Reg.St.Cl.Psych.Hosp.Dept.#20, LNMU n.a.D. Halytskiy Chair of Psychiatry, Psychology and Sexololgy
      • Odessa, Ukraine, 65006
        • Odesa SMU, based on Odessa Reg. Psychiatric Hosp.#1
      • Poltava, Ukraine, 36006
        • Reg. Ci.Ps.H.n.a.O.F.Maltsev, Fem.Ac.Gen.Ps. D.5B,HESIU UM
      • Simferopol, Ukraine
        • Crimean republican Clinical Psychiatric Hospital
      • Ternopil, Ukraine, 46020
        • Ternopil Regional Municipal Dispensary, Narcology Dept., Ch. of Neurol. Psych. Narcol. & Med. Psychol.
      • Vinnitsia, Ukraine, 21018
        • Reg. Psych. Hosp.n.a. O.Yuschenko, Dept. #121 VNMI
      • Zaporizhzhia, Ukraine, 69032
        • Zapor Reg. Cl. Hosp., Zaporizhzhia SMU, ENT Dept.
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Woodland International Research Inc
    • California
      • Anaheim, California, United States, 92804
        • South Coast Clinical Trials Inc.
      • Chino, California, United States, 91710
        • Catalina Research Institute
      • Costa Mesa, California, United States, 92626
        • Clinical Innovations Inc.
      • Escondido, California, United States, 92025
        • Synergy Escondido
      • Garden Grove, California, United States, 92645
        • Collaborative Neuroscience Network Inc
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center
      • Maitland, California, United States, 32751
        • Florida Clinical Research Center LLC
      • Oceanside, California, United States, 92056
        • Excell Research, Inc
      • Orange, California, United States, 92868
        • University of California at Irvine Medical Center
      • Pico Rivera, California, United States, 90660
        • CNRI - Los Angeles LLC
      • Riverside, California, United States, 92506
        • Clinical Innovations Inc.
      • San Diego, California, United States, 92123
        • Sharp Mesa Vista Hospital
      • San Diego, California, United States, 92102
        • California Neuropsychopharmacology Clinical Research Instit
      • San Diego, California, United States, 92123
        • Artemis Institute For Clinical Research LLC
      • Santa Ana, California, United States, 92705
        • Clinical Innovations Inc.
      • Stanford, California, United States, 94305
        • Stanford University School of Medicine
      • Torrance, California, United States, 90502
        • Collaborative Neuroscience Network Inc.
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado
      • Colorado Springs, Colorado, United States, 80917
        • MCB Clinical Research Centers-Colorado Springs
    • Florida
      • Bradenton, Florida, United States, 34208
        • Florida Clinical Research Center LLC
      • Fruitland park, Florida, United States, 34731
        • Florida Clinical Research Center LLC
      • Kissimmee, Florida, United States, 34741
        • Accurate Clinical Trials
      • Orlando, Florida, United States, 32806
        • Clinical Neuroscience Solutions Inc.
      • Tampa, Florida, United States, 33613
        • University of South Florida Institute - Tampa
      • West Palm Beach, Florida, United States, 33407
        • Janus Center For Psychiatric Research
    • Georgia
      • Rosewekk, Georgia, United States, 30076
        • Northwest Behavioral Research Center
      • Smyrna, Georgia, United States, 30080
        • Institute for Behavioral Medicine LLC
    • Illinois
      • Oak Brook, Illinois, United States, 60523
        • American Medical Research
    • Louisiana
      • Lake Charles, Louisiana, United States, 70601
        • Lake Charles Clinical Trials LLC
      • Shreveport, Louisiana, United States, 71104
        • Booker, J. Gary, MD. APMC
    • Maryland
      • Baltimore, Maryland, United States, 21285
        • Sheppard Pratt Health System
      • Rockville, Maryland, United States, 20852
        • Capitol Clinical Research
    • Mississippi
      • Flowood, Mississippi, United States, 39232
        • Precise Research Centers
    • Missouri
      • St. Charles, Missouri, United States, 63301
        • Midwest Research Group
    • New Jersey
      • Willingboro, New Jersey, United States, 08046
        • CRI Worldwide, LLC
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • Albuquerque Neuroscience Inc.
    • New York
      • Brooklyn, New York, United States, 11235
        • Social Psychiatry Research Institute
      • Cedarhurst, New York, United States
        • Neurobehavioral Research, Inc
      • New York, New York, United States, 10003
        • Village Clinical Research Inc.
      • New York, New York, United States, 10023
        • Medical & Behavioral Health Research PC
      • Rochester, New York, United States, 14618
        • Finger Lakes Clinical Research
    • North Carolina
      • Raleigh, North Carolina, United States, 27607
        • Zarzar Psychiatric Associates PLLC
      • Raleigh, North Carolina, United States, 27609
        • Richard H. Weisler & Associates
    • Ohio
      • Avon Lake, Ohio, United States, 44012
        • Quest Therapeutics
      • Cincinnati, Ohio, United States, 45267
        • Psychiatric Professional Services Inc
      • Cleveland, Ohio, United States, 44106
        • Mood Disorders Program-UHCMC
      • Cleveland, Ohio, United States, 44122
        • MetroHealth System
      • Dayton, Ohio, United States, 45408
        • Midwest Clinical Research Center
    • Oregon
      • Portland, Oregon, United States, 97210
        • Summit Research Network (Oregon) Inc.
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Lehigh Valley Hospital
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Clinical Neuroscience Solutions Inc.
    • Texas
      • Austin, Texas, United States, 78756
        • FutureSearch Clinical Trials LP
      • Dallas, Texas, United States, 75231
        • FutureSearch Trials
      • Dallas, Texas, United States, 75243
        • Pillar Clinical Research LLC
      • Houston, Texas, United States, 77090
        • Red Oak Psychiatry Associates, PA
      • Wharton, Texas, United States, 77488
        • Wharton Research Center
    • Washington
      • Seattle, Washington, United States, 98104
        • Summit Research Network (Seattle) Llc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: lurasidone
Drug: lurasidone
Lurasidone 20-120 mg/d Flexibly Dosed - 24 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Open-label Extension Baseline to Week 24 (Month 6/LOCF Endpoint) in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Time Frame: 24 weeks
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
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)
Time Frame: 24 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sunovion

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

March 23, 2009

First Submitted That Met QC Criteria

March 24, 2009

First Posted (Estimate)

March 25, 2009

Study Record Updates

Last Update Posted (Estimate)

April 14, 2016

Last Update Submitted That Met QC Criteria

March 15, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D1050256
  • EUDRACT No. 2008-007483-42

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Bipolar Depression

Clinical Trials on lurasidone

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Norway

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe