SchizophreniaPhase 3NCT01485640
Lurasidone Extended Use Study
A Phase 3 study testing Lurasidone in people with Schizophrenia and Bipolar Disorder, run by Sumitomo Pharma America, Inc. at 46 sites in 12 countries.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Schizophrenia, Bipolar Disorder
- What is being tested?
- Lurasidone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 46 sitesin 12 countries
- Study dates
- Jun 2011to Feb 2014
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
46 sites in 12 countries.
46 sites in 12 countries
India11 sites
Samvedna Hospitals
Ahmedabad, Gujarat, 380006
Seth K M School of P G Medicine & Research
Ahmedabad, Gujarat, 380006
Mental Health Treatment Rehabililitation Foundation Dept. of Psychiatry
Ahmedabad, Gujarat, 380013
Shanti Nursing Home
Aurangabad, Maharashtra, 431005
Dr. Tambi's Neuropsychiatry Center
Jaipur, Rajaasthan, 302017
R.K. Yadav Memorial Mental Health & De-Addiction Hospital Psychiatry
Jaipur, Rajasthan, 302021
Hatkesh Healthcare Foundation
Jūnāgadh, Gujarat, 362001
Mahendru Psychiatric Centre
Kanpur, 208005
Brij Psychiatry Hospital & Muskaan Research Centre
Vadodara, Gujarat, 390001
Vijayawada Institute of Mental Health and Neurosciences
Vijayawada, Andhra Pradesh, 520002
Brain Mind Behavior Neuroscience Research Institute
Visakhapatnam, Andh Prad, 530002
Ukraine6 sites
Dnipropetrovsk Regional Clinical Hospital named Mechnikov
Dnipropetrovsk, 49005
Regional Clinical Psychiatric Hospital, Dept #11
Donetsk, 83037
Institute of Neurology, Psychiatry and Narcology, NAMS of Ukraine
Khardov, 61068
Kherson Regional Psychiatric Hospital
Kherson, Vil Stepanivka, 73488
Crimean republican Clinical Psychiatric Hospital
Simferopol
Reg. Psych. Hosp.n.a.O.Yuschenko, Dept #21
Vinnitsia, 21018
Czechia5 sites
Psychiatricka ambulance
Brno-mesto, 602 00
Vojenska nemocnice Olomouc
Olomouc, 711 11
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
Russia4 sites
Regional Government Institution (RGI) 'Lipetsk Regional Psychoneurology Hospital'
Lipetsk, 398007
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
St. Petersburg State Government Healthcare Institution "City Psychiatric Hospital #4" (St. Petersburg Insane Asylum Distributor)
Saint Petersburg, 191119
St. Petersburg State Healthcare Institution (SPbSHI) "City Psychiatric Hospital #6"
Saint Petersburg, 191167
Slovakia4 sites
Psychiatricka ambulancia Mentum s.r.o.
Bratislava, 82007
PsychoLine s.r.o. Psychiatricka ambulancia
Rimavská Sobota, 97901
Centrum zdravia R.B.K. s.r.o. Psychiatricka ambulancia
Svidník, 08901
Pro mente sana s.r.o. Psychiaricka ambulancia
Trenčín, 91101
Colombia3 sites
Centro de Investigaciones y Proyectos en Neurociencias CIPNA Investigations
Barranquilla
E.S.E. Hospital Mental de Antioquia
Bello
CISNE - UIC Campo Abierto
Bogotá
Lithuania3 sites
Neuromeda JSC
Kaunas, 50185
JSC Neuromeda
Kaunas, LT-50185
Seskines Outpatient Clinic, Public Institution
Vilnius, 07156
South Africa3 sites
Dey Clinic
Pretoria, Gauteng, 181
Denmar Hospital Consulting Rooms
Pretoria, 0081
Cape Trial Centre
Tygervalley, Western Cape, 7530
France2 sites
Zans Ritter, Marcel
Orvault, 44700
Hôpital Chalucet, Centre hospitalier intercommunal de Toulon la Seyne sur mer (CHITS)
Toulun, 83000
Romania2 sites
Spitalul Clinic Judetean de Urgenta Cluj
Cluj-Napoca, 400012
Spitalul Clinic de Neuropsihiatrie Craiova
Craiova, 200620
Serbia2 sites
Institute of Mental Health
Belgrade, 11000
Clinical Centre Nis, Clinic for mental health protection
Niš, 18000
About this study
Official title: A Long-term, Multicenter, Open-Label, Flexible Dose Continuation Study in Subjects Who Have Completed a Prior Lurasidone Study
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
- Being tested
- Lurasidone
- Keywords
- Schizophrenia, bipolar disorder, Lurasidone, Latuda
- Medical subject headings
- Schizophrenia, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LurasidoneDrug
Lurasidone flexibly dosed; doses of 20, 40, 60 or 80 mg/day will be taken orally with food
| Study group | Role | What they receive |
|---|---|---|
| Lurasidone | Experimental | Lurasidone flexibly dosed Receives: Drug: Lurasidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 months
Secondary outcomes (1)
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.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2011 (estimated)
- Study startJun 2011
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sumitomo Pharma America, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, MD, Study director, Sumitomo Pharma America, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01485640
- Sponsor's protocol ID
- D1050298
- Other IDs
- 2011-000682-12
- Status last verified
- Sep 2016
- First submitted
- 1 Dec 2011
- Last updated
- 4 Nov 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Long-term, Multicenter, Open-Label, Flexible Dose Continuation Study in Subjects Who Have Completed a Prior Lurasidone Study
- ClinicalTrials.gov ID
- NCT01485640
- Acronym / sponsor ID
- D1050298
- Conditions
- Schizophrenia, Bipolar Disorder
- Keywords
- Schizophrenia, bipolar disorder, Lurasidone, Latuda
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Sumitomo Pharma America, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 5 Dec 2011 (estimated)
- Results
- Posted 11 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lurasidone | Experimental | Drug: LurasidoneLurasidone flexibly dosed |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LurasidoneLurasidone flexibly dosed; doses of 20, 40, 60 or 80 mg/day will be taken orally with food | Drug | Lurasidone |
Primary outcome
Number of Subjects With Treatment Emergent AEs, SAEs or Who Discontinued Due to AEs
Time frame: 18 months
Primary Safety assessments included spontaneous adverse event (AE) and serious adverse events (SAEs) monitoring.
1 secondary outcome
Change From Baseline to Month 18 (LOCF) in the Clinical Global Impression Severity Score (CGI-S
Time frame: 18 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director, MD study director
Sumitomo Pharma America, Inc.
46 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lurasidone in people with Schizophrenia and Bipolar Disorder, run by Sumitomo Pharma America, Inc. at 46 sites in 12 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 4 inclusion and 4 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 4 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 46 sites in India, Ukraine, Czechia, Russia, Slovakia and 7 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 11 Mar 2015). 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 Subjects With Treatment Emergent AEs, SAEs or Who Discontinued Due to AEs (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Nov 2016.