SchizophreniaPhase 3NCT01566162
A Twelve Week, Open Label Extension Study in Patients With Schizophrenia
A Phase 3 study testing Lurasidone in people with Schizophrenia, run by Sumitomo Pharma America, Inc. at 63 sites in 7 countries.
Trial summary
This is a 12-week, multi-center, open-label extension study designed to evaluate the longer-term safety, tolerability and effectiveness of lurasidone for the treatment of subjects with schizophrenia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia
- 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
- 191 participants
- Where
- 63 sitesin 7 countries
- Study dates
- Apr 2012to Nov 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has agreed to participate by providing written informed consent.
- Subject will be eligible to participate if one of the following criteria is met:
- Subject has completed the 28-week double-blind phase of study D1050238
- Subject has experienced a protocol-defined relapse event during the double- blind phase in study D1050238
- Subject is participating in the open-label or double-blind phase of study D1050238 if/when study D1050238 is terminated by the sponsor.
- Subject has completed all required assessments on the final study visit (Study Visit Number 42) in study D1050238.
- Subject is judged by the Investigator to be suitable for participation in a 12-week clinical trial involving open-label lurasidone treatment and is able to comply with the protocol in the opinion of the Investigator.
Who cannot join
- Subject is considered by the investigator to be at imminent risk of suicide or injury to self, others, or property.
- Subject answers "yes" to "Suicidal Ideation" item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) on the C-SSRS at the extension baseline visit (Study Visit Number 42 in study D1050238). Subjects who answer "yes" to this question must be referred by the Investigator for appropriate follow-up evaluation and treatment.
- Subject tests positive for drugs of abuse or is suspected of current alcohol abuse at the extension baseline visit (Study Visit Number 42 in study D1050238). In the event a subject tests positive for cannabinoids, the Investigator will evaluate the subject's ability to abstain from cannabis during the study.
Trial locations and contacts
63 sites in 7 countries.
63 sites in 7 countries
United States38 sites
Atlanta Center for Medical Research
Atlanta, Georgia, 30308
Comprehensive NeuroScience Inc.
Atlanta, Georgia, 30328
Community Clinical Research, Inc.
Austin, Texas, 78754
FutureSearch Clinical Trials LP
Austin, Texas, 78756
Florida Clinical Research Center, LLC
Bradenton, Florida, 34208
Erie County Medical Center, Corp
Buffalo, New York, 14215
Neurobehavioral Research Inc.
Cedarhurst, New York, 11516
Comprehensive Clinical Development Inc.
Cerritos, California, 90703
FutureSearch Clinical Trials, LP
Dallas, Texas, 75231
Pillar Clinical Research, LLC
Dallas, Texas, 75243
Diligent Clinical Trials
Downey, California, 90241
Synergy Clinical Research Center
Escondido, California, 92025
Comprehensive Clinical Development, Inc
Fresh Meadows, New York, 11366
CNS Network
Garden Grove, California, 92845
Accurate Clinical Trials
Kissimmee, Florida, 34742
Lake Charles Clinical Trials, LLC
Lake Charles, Louisiana, 70601
Robert Lynn Horne, MD
Las Vegas, Nevada, 89102
Lincoln Research
Lincoln, Rhode Island, 02865
K and S Professional Research Services
Little Rock, Arkansas, 72201
Woodland International Research Inc.
Little Rock, Arkansas, 72211
AXIS Clinical Trials
Los Angeles, California, 90036
Galiz Research
Miami Springs, Florida, 33166
Synergy Clinical Research Center
National City, California, 91950
Psychiatric Care and Research Center
O'Fallon, Missouri, 63368
Excell Research, Inc.
Oceanside, California, 92056
Oklahoma Clinical Research
Oklahoma City, Oklahoma, 73116
Medical Research Group of Central Florida
Orange City, Florida, 32763
CRI Worldwide LLC at Kirkbride
Philadelphia, Pennsylvania, 19139
CNRI-Los Angeles. LLC
Pico Rivera, California, 90660
Finger Lakes Clinical Research
Rochester, New York, 14618
Center for Behavioral Health, LLC
Rockville, Maryland, 20850
Department of Psychiatry, University of Utah Health Sciences Center
Salt Lake City, Utah, 84132
California Neuropsychopharmacolgoy Clinical Research Insitute
San Diego, California, 92126
Neuropsychiatric Research Center of Orange County
Santa Ana, California, 92701
Lousiana Clinical Research, LLC
Shreveport, Louisiana, 71104
Psych Care Consultants Research
St Louis, Missouri, 63128
Collaborative Neuroscience Network
Torrance, California, 90502
CRI Worldwide LLC
Willingboro, New Jersey, 08046
Russia6 sites
Regional Government Institution (RGI) 'Lipetsk Regional Psychoneurology Hospital'
Lipetsk, 398007
Limited Liability Company (LLC) 'Research Center For Treatment and rehabilitation 'Phoenix'
Rostov-on-Don, 344000
St. Petersburg State Healthcare Institution (SPbSHI) "City Psychiatric Hospital #6"
Saint Peterburg, 191167
St. Petersburg State Budgetary Healthcare Institution 'City Psychoneurology Dispensary #7 (with In-Patient Department)', (SPb SBHI "CPNDD-7")
Saint Petersburg, 190005
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
Serbia6 sites
Military Medical Academy, Clnic for Psychiatry
Belgrade, 11000
Institute of Mental Health
Dusica, 11000
Clinical Centre Kragujevac, Clinic for psychiatry
Kragujevac, 34000
Clinical Centre Nis, Clinic for mental health protection
Niš, 18000
Specialized hospital for psychiatric diseases "Sveti Vracevi"
Novi Kneževac, 23330
Clinical Centre Vojvodine, Clinic for Psychiatry
Novi Sad, 21000
Slovakia6 sites
Nemocnica s poliklinikou v Prievidzi so sidlom v Bojniciach, Psychiatricke oddelenie
Bojnice, 972 01
Psychiatricka ambulancia Mentum s.r.o.
Bratislava, 82007
Psychiatricka nemocnica Michalovce n.o.
Michalovce, 071 01
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., spol. s.r.o.
Svidník, 089 01
South Africa3 sites
Research Unit, Department of Psychiatry Free State Psychiatric Complex
Bloemfontein, 9300
Denmar Hospital Consulting Rooms
Pretoria, 0081
Cape Trial Centre
Tygervalley, Western Cape, 7530
France2 sites
Centre Hospitalier Spécialisé (CHS) du Jura - Centre Médico Psychiatrique (CMP)
Dole, 39100
Hôpital Chalucet, Centre hospitalier intercommunal de Toulon la Seyne sur mer (CHITS)
Toulon, 83000
Italy2 sites
Dipartimento Salute Mentale ASL 1
Massa, 54100
A.O.U. Santa Chiara, U.O di Psichiatria 1 building n.4
Pisa, 56100
About this study
Official title: A Twelve Week, Multicenter, Open Label Extension Study in Subjects With Schizophrenia
This is a 12-week, multi-center, open-label extension study designed to evaluate the longer-term safety, tolerability and effectiveness of lurasidone for the treatment of subjects with schizophrenia.
Read the detailed description
This is a 12-week, multi-center, open-label extension study designed to evaluate the longer-term safety, tolerability and effectiveness of lurasidone for the treatment of subjects with schizophrenia who have participated in Study D1050238, a double-blind, placebo-controlled, randomized withdrawal study of lurasidone for the maintenance treatment of subjects with schizophrenia. Subjects who have completed the 28-week double-blind phase or who have experienced a protocol-defined relapse event during the double-blind phase of study D1050238 will have the option to participate in this study. In addition, if/when the study is discontinued by the sponsor, all subjects participating in the open-label phase and the double-blind phase of study D1050238 will have the option to participate in this extension study
- Conditions
- Schizophrenia
- Being tested
- Lurasidone
- Keywords
- Lurasidone, Latuda, Schizophrenia
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LurasidoneDrug
Lurasidone 40-80 mg taken orally taken once daily
| Study group | Role | What they receive |
|---|---|---|
| Lurasidone | Experimental | Lurasidone 40 - 80mg flexible dose Receives: Drug: Lurasidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety - Treatment-emergent Adverse Events (TEAEs), TEAEs Leading to Discontinuation, and Serious AEs (SAEs)
Number of subjects with treatment-emergent adverse events (TEAEs), TEAEs leading to discontinuation, and serious AEs (SAEs)
Measured: 12 weeks
Efficacy - Change in Positive and Negative Syndrome Scale (PANSS) Total Score
The PANSS is an interview-based measure of the severity of psychopathology in adults with psychotic disorders. The measure is comprised of 30 items. An anchored Likert scale from 1-7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. The PANSS total score is the sum of all 30 items and ranges from 30 through 210. A higher score is associated with greater illness severity.
Measured: Baseline to week 12 LOCF endpoint
Efficacy - Change From Baseline in Clinical Global Impression-Severity of Illness (CGI-S) Score.
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: Baseline to week 12 LOCF endpoint
Secondary outcomes (6)
Change From Baseline in Montgomery -Asberg Depression Rating Scale Total Score
The MADRS consists of 10 items, each rated on a Likert scale, from 0="Normal" to 6="Most Severe". The MADRS total score is calculated as the sum of the 10 items. The MADRS total score ranges from 0 to 60. Higher scores are associated with greater severity.
Measured: Baseline to week 12 LOCF endpoint
Short Form-12 Health Survey (SF-12)
The SF-12v2 is a self-administered, multipurpose short-form (SF) generic measure of health status. It was developed to be a shorter, yet valid, alternative to the SF-36 for use in large surveys of general and specific populations as well as in large longitudinal studies of health outcomes. The 12 items in the SF-12v2 are a subset of those in the SF-36; SF-12v2 includes one or two items from each of the eight health concepts with higher scores indicative of higher functioning and better health. The Physical Component Score is a composite of the Physical Functioning, Role Functioning, Bodily Pain and General Health scales. Physical Composite Scores (PCS) is computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.
Measured: Baseline to week 12 LOCF endpoint
Modified Specific Levels of Functioning (SLOF) Total Score.
The modified SLOF scale is designed to measure directly observable behavioral functioning and daily living skills of patients with chronic mental illness. The modified SLOF consists of 24 items, each item is rated on a 5-point scale and mapped to 0 to 4. The total score will be the sum of all 24 items and ranges from 0 to 96. A higher score indicates worse condition.
Measured: 12 weeks
Brief Adherence Rating Scale (BARS)
The Brief Adherence Rating Scale (BARS) is a clinician-administered adherence assessment instrument that consists of four items including three questions and a visual analog rating scale (VAS) to assess the percentage (0 100%) of doses taken by the subject in the previous month.
Measured: 12 weeks
Smoking Questionnaire
Smoking questionnaire - average number of cigarettes per day at week 12 (LOCF).
Measured: 12 weeks
Intent to Attend Assessment
The ITA assessment will be administered by a research staff member. The response is recorded on a 10-point scale, with 0 = "Not at all" and 9 = "Extremely". The ITA allowed the site to capture data regarding dropout risk. The following question was completed at the baseline visit: "How likely is it that you will complete the study?"
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2012 (estimated)
- Study startApr 2012
- Primary completionNov 2013
- Study completionNov 2013
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
- 191 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sumitomo Pharma America, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lurasidone Medical Director, MD, Study director, Sumitomo Pharma America, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01566162
- Sponsor's protocol ID
- D1050307
- Other IDs
- 2011-004790-90
- Status last verified
- Apr 2019
- First submitted
- 27 Mar 2012
- Last updated
- 9 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Twelve Week, Multicenter, Open Label Extension Study in Subjects With Schizophrenia
- ClinicalTrials.gov ID
- NCT01566162
- Acronym / sponsor ID
- D1050307
- Conditions
- Schizophrenia
- Keywords
- Lurasidone, Latuda, Schizophrenia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 191 participants (actual)
- Lead sponsor
- Sumitomo Pharma America, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 29 Mar 2012 (estimated)
- Results
- Posted 20 Nov 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a 12-week, multi-center, open-label extension study designed to evaluate the longer-term safety, tolerability and effectiveness of lurasidone for the treatment of subjects with schizophrenia.
Detailed description
This is a 12-week, multi-center, open-label extension study designed to evaluate the longer-term safety, tolerability and effectiveness of lurasidone for the treatment of subjects with schizophrenia who have participated in Study D1050238, a double-blind, placebo-controlled, randomized withdrawal study of lurasidone for the maintenance treatment of subjects with schizophrenia. Subjects who have completed the 28-week double-blind phase or who have experienced a protocol-defined relapse event during the double-blind phase of study D1050238 will have the option to participate in this study. In addition, if/when the study is discontinued by the sponsor, all subjects participating in the open-label phase and the double-blind phase of study D1050238 will have the option to participate in this extension study
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 40 - 80mg flexible dose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subject has agreed to participate by providing written informed consent.
- Subject will be eligible to participate if one of the following criteria is met:
- Subject has completed the 28-week double-blind phase of study D1050238
- Subject has experienced a protocol-defined relapse event during the double- blind phase in study D1050238
- Subject is participating in the open-label or double-blind phase of study D1050238 if/when study D1050238 is terminated by the sponsor.
Key exclusion criteria (3 listed)
- Subject is considered by the investigator to be at imminent risk of suicide or injury to self, others, or property.
- Subject answers "yes" to "Suicidal Ideation" item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) on the C-SSRS at the extension baseline visit (Study Visit Number 42 in study D1050238). Subjects who answer "yes" to this question must be referred by the Investigator for appropriate follow-up evaluation and treatment.
- Subject tests positive for drugs of abuse or is suspected of current alcohol abuse at the extension baseline visit (Study Visit Number 42 in study D1050238). In the event a subject tests positive for cannabinoids, the Investigator will evaluate the subject's ability to abstain from cannabis during the study.
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 40-80 mg taken orally taken once daily | Drug | Lurasidone |
Primary outcome
Safety - Treatment-emergent Adverse Events (TEAEs), TEAEs Leading to Discontinuation, and Serious AEs (SAEs)
Time frame: 12 weeks
Number of subjects with treatment-emergent adverse events (TEAEs), TEAEs leading to discontinuation, and serious AEs (SAEs)
Efficacy - Change in Positive and Negative Syndrome Scale (PANSS) Total Score
Time frame: Baseline to week 12 LOCF endpoint
The PANSS is an interview-based measure of the severity of psychopathology in adults with psychotic disorders. The measure is comprised of 30 items. An anchored Likert scale from 1-7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. The PANSS total score is the sum of all 30 items and ranges from 30 through 210. A higher score is associated with greater illness severity.
Efficacy - Change From Baseline in Clinical Global Impression-Severity of Illness (CGI-S) Score.
Time frame: Baseline to week 12 LOCF endpoint
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.
6 secondary outcomes
Change From Baseline in Montgomery -Asberg Depression Rating Scale Total Score
Time frame: Baseline to week 12 LOCF endpoint
Short Form-12 Health Survey (SF-12)
Time frame: Baseline to week 12 LOCF endpoint
Modified Specific Levels of Functioning (SLOF) Total Score.
Time frame: 12 weeks
Brief Adherence Rating Scale (BARS)
Time frame: 12 weeks
Smoking Questionnaire
Time frame: 12 weeks
Intent to Attend Assessment
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2019.
- 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.
Lurasidone Medical Director, MD study director
Sumitomo Pharma America, Inc.
63 sites in 7 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, run by Sumitomo Pharma America, Inc. at 63 sites in 7 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 7 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 9 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 63 sites in United States, Russia, Serbia, Slovakia, South Africa and 2 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 20 Nov 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?
Safety - Treatment-emergent Adverse Events (TEAEs), TEAEs Leading to Discontinuation, and Serious AEs (SAEs) (time frame: 12 weeks). The study lists 3 primary outcomes in all. 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 9 Apr 2019.