SchizophreniaPhase 3NCT00641745
Lurasidone HCl - A Long Term Safety Phase 3 Study of Patients With Clinically Stable Schizophrenia
A Phase 3 study testing Lurasidone HCl and Risperidone in people with Schizophrenia and Schizoaffective Disorder, run by Sumitomo Pharma America, Inc. at 73 sites in 8 countries.
Trial summary
Lurasidone HCl is a compound being developed for the treatment of schizophrenia. This clinical study is designed to test the hypothesis that lurasidone is safe and tolerable long term among clinically stable patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder
- What is being tested?
- Lurasidone HCl and Risperidone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 629 participants
- Where
- 73 sitesin 8 countries
- Study dates
- Mar 2008to Jul 2010
- 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
Main Inclusion Criteria:
To be eligible to enter the study, each patient must comply with the following inclusion criteria:
- Subject is 18 to 75 years on the day of signing the consent form (age parameters may be restricted further per local requirements without protocol amendment).
- Subject meets Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria for a primary diagnosis of schizophrenia (including disorganized (295.10), paranoid (295.30), undifferentiated (295.90), catatonic (295.20), or residual (295.60) or schizoaffective disorder (295.70) subtypes.
- Subject is not pregnant or nursing, and is not planning pregnancy within the projected duration of the study.
- Subject will comply with the study procedures and outpatient visit requirements in the opinion of the investigator.
- Subject voluntarily agrees to participate in the study by giving written informed consent.
Main Exclusion Criteria:
To be excluded from entering this study if they fulfil any of the criteria below:
- Subject has a chronic organic disease of the central nervous system (other than schizophrenia).
- Subject has current clinically significant or history of, alcohol abuse/alcoholism or drug abuse/dependence within the last 6 months.
- In the opinion of the investigator, the subject has any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study, or interfere with the subject's participation for the full duration of the study.
- Subject has participated in a study with an investigational compound or device within 30 days of signing informed consent.
Trial locations and contacts
73 sites in 8 countries.
73 sites in 8 countries
United States41 sites
South Coast Clinical Trials, Inc.
Anaheim, California, 92804
Atlanta Center for Medical Research
Atlanta, Georgia, 30308
Community Clinical Research, Inc.
Austin, Texas, 78754
Sheppard Pratt Health System
Baltimore, Maryland, 21285
SUNY Downstate University
Brooklyn, New York, 11203
Neurobehavioral Research Inc.
Cedarhurst, New York, 11516
Comprehensive NeuroScience, Inc. - Cerritos
Cerritos, California, 90703
Clinical Innovations Inc.
Costa Mesa, California, 92626
Pillar Clinical Research LLC
Dallas, Texas, 75243
Precise Research Center
Flowood, Mississippi, 39232
Collaborative Neuroscience Network Inc
Garden Grove, California, 92845
Alexian Brothers Medical Center
Hoffman Estates, Illinois, 60169
Claghorn-Lesem Research Clinic, Inc.
Houston, Texas, 77008
Lake Charles Clinical Trials
Lake Charles, Louisiana, 70601
K&S Professional Research Services LLC
Little Rock, Arkansas, 72201
Woodland International Research Group, LLC
Little Rock, Arkansas, 72211
University of Southern California
Los Angeles, California, 90033
Research Strategies of Memphis LLC
Memphis, Tennessee, 38119
Manhattan Psychiatric Center
New York, New York, 10035
Social Psychiatry Research Institute
New York, New York, 10454
Keystone Clinical Studies, LLC
Norristown, Pennsylvania, 19403
Fidelity Clinical Research Inc., c/o Segal Institute for Clinical Research
North Miami, Florida, 33161
Fidelity Clinical Research Inc.
North Miami, Florida, 33161
Excell Research
Oceanside, California, 92056
Creighton University
Omaha, Nebraska, 68131
University of California at Irvine Medical Center
Orange, California, 92868
Pasadena Research Institute
Pasadena, California, 91107
CRI Worldwide
Philadelphia, Pennsylvania, 19139
CNRI-Los Angeles, LLC
Pico Rivera, California, 90660
University of North Carolina at Chapel Hill
Raleigh, North Carolina, 27603
Alliance Research Group
Richmond, Virginia, 23230
Clinical Innovations Inc.
Riverside, California, 92506
St. Charles Psychiatric Associates - Midwest Research
Saint Charles, Missouri, 63301
CNRI-San Diego LLC
San Diego, California, 92102
UCSD, Outpatient Psychiatric Services
San Diego, California, 92103
Clinical Innovations Inc.
Santa Ana, California, 92705
St. Louis Clinical Trials
St Louis, Missouri, 63118
Collaborative Neuroscience Network Inc
Torrance, California, 90502
Northlake Medical Research Center
Tucker, Georgia, 30084
Comprehensive NeuroScience, Inc.
Washington D.C., District of Columbia, 20016
CRI Worldwide
Willingboro, New Jersey, 08046
South Africa7 sites
Oranje Hospital
Bloemfontein, Free State, 9301
Flexivest fourteen Research Centre
Cape Town, W Cape, 7535
Cape Trial Centre
Cape Town, 7530
Rand Clinic
Johannesburg, Gauteng, 2198
Crompton Medical Centre East
Natal, 3600
Private Practice
Pretoria, Gauteng, 0181
Weskoppies Hospital
Pretoria West, 0001
Argentina5 sites
Fundación para el Estudio y Tratamiento de las Enf. Mentales
Capital Federal, BUE, C1425AHP
Sanatorio 'Prof. Leon S. Morra' S.A.
Córdoba, X5009BIN
Clinica Privada Neuropsiquiatrica San Agustin
La Plata, BUE, 1900
Resolution Psychopharmacology Research Institute
Mendoza, MEN, M5502HLE
CIAP
Rosario, SFE, S2000QJI
Chile5 sites
Hospital Clincio Felix Bulnes
Quinta Normal, Santiago Metropolitan
Instituto Psiquiátrico Dr. José Horwitz Barak
Recoleta, Santiago Metropolitan
Hospital Barros Luco Trudeau
San Miguel, Santiago Metropolitan
CIPAM - Clínica Pedro Montt
Santiago, Santiago Metropolitan
Hospital Base Valdivia
Valdivia, Valdivia
Israel5 sites
Beer Ya'acov Mental Health Center
Beer Yaakov, Beer Yaakov, 70300
Rambam Health Care Campus
Haifa, Haifa District, 31096
Shalvata Mental Health Center
Hod HaSharon, Hod Hasharon, 45100
Shalvata Mental Health Center, Ward B
Hod HaSharon, 45100
Chaim Sheba Medical Center
Ramat Gan, Ramat Gan, 52621
Brazil4 sites
PAX Clinica Psiquiatrica Ltda
Aparecida de Goiânia, 74922-810
Hospital Espirita de Psiquiatria Bom Retiro
Curitiba, Paraná, 80520-000
Hospital Mario Kroeff
Rio de Janeiro, Rio de Janeiro, 21020-130
Sanatorio Sao Paulo
Salvador, Estado de Bahia, 40301-500
Croatia3 sites
Clinical Hospital Centre Rijeka
Rijeka, Rijeka, 51 000
Psychiatric Hospital Vrapce
Zagreb, City of Zagreb, 10 090
Croatian institute for brain research Neuron
Zagreb, City of Zagreb, 10000
Thailand3 sites
King Chulalongkorn Memorial Hospital
Chulalongkorn University, Bangkok
Somdet Chaopraya Institute of Psychiatry
Klongsan, Bangkok
Suan Prung Psychiatric Hospital
Muang, Chiang Mai
About this study
Official title: Long-Term Safety, Tolerability, and Effectiveness of Lurasidone in Subjects With Schizophrenia or Schizoaffective Disorder: A Randomized, Active Comparator-Controlled Trial
Lurasidone HCl is a compound being developed for the treatment of schizophrenia. This clinical study is designed to test the hypothesis that lurasidone is safe and tolerable long term among clinically stable patients. The study will also assess the long term effectiveness of lurasidone as compared to an active comparator.
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Being tested
- Lurasidone HCl, Risperidone
- Keywords
- Lurasidone, Schizophrenia, Latuda
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lurasidone HClDrug
40 - 120mg per day
RisperidoneDrug
Risperidone
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Lurasidone Receives: Drug: Lurasidone HCl |
| 2 | Active comparator | Risperidone Receives: Drug: Risperidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2008 (estimated)
- Study startMar 2008
- Primary completionJul 2010
- Study completionJul 2010
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.
- Publications (5)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 629 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
- NCT00641745
- Sponsor's protocol ID
- D1050237
- Status last verified
- Jun 2015
- First submitted
- 18 Mar 2008
- Last updated
- 22 Jun 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Keefe RS, Fox KH, Harvey PD, Cucchiaro J, Siu C, Loebel A. Characteristics of the MATRICS Consensus Cognitive Battery in a 29-site antipsychotic schizophrenia clinical trial. Schizophr Res. 2011 Feb;125(2-3):161-8. doi: 10.1016/j.schres.2010.09.015. Epub 2010 Dec 31.
PubMed 21075600Citrome L, Cucchiaro J, Sarma K, Phillips D, Silva R, Tsuchiya S, Loebel A. Long-term safety and tolerability of lurasidone in schizophrenia: a 12-month, double-blind, active-controlled study. Int Clin Psychopharmacol. 2012 May;27(3):165-76. doi: 10.1097/YIC.0b013e32835281ef.
PubMed 22395527Patel PJ, Weidenfeller C, Jones AP, Nilsson J, Hsu J. Long-Term Assessment of Lurasidone in Schizophrenia: Post Hoc Analysis of a 12-Month, Double Blind, Active-Controlled Trial and 6-Month Open-Label Extension Study. Neurol Ther. 2021 Jun;10(1):121-147. doi: 10.1007/s40120-020-00221-4. Epub 2020 Oct 24.
PubMed 33098548Mattingly GW, Haddad PM, Tocco M, Xu J, Phillips D, Pikalov A, Loebel A. Switching to Lurasidone following 12 months of treatment with Risperidone: results of a 6-month, open-label study. BMC Psychiatry. 2020 May 5;20(1):199. doi: 10.1186/s12888-020-02523-1.
PubMed 32370778Georgiades A, Davis VG, Atkins AS, Khan A, Walker TW, Loebel A, Haig G, Hilt DC, Dunayevich E, Umbricht D, Sand M, Keefe RSE. Psychometric characteristics of the MATRICS Consensus Cognitive Battery in a large pooled cohort of stable schizophrenia patients. Schizophr Res. 2017 Dec;190:172-179. doi: 10.1016/j.schres.2017.03.040. Epub 2017 Apr 20.
PubMed 28433500
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Safety, Tolerability, and Effectiveness of Lurasidone in Subjects With Schizophrenia or Schizoaffective Disorder: A Randomized, Active Comparator-Controlled Trial
- ClinicalTrials.gov ID
- NCT00641745
- Acronym / sponsor ID
- D1050237
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Keywords
- Lurasidone, Schizophrenia, Latuda
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 629 participants (actual)
- Lead sponsor
- Sumitomo Pharma America, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 24 Mar 2008 (estimated)
- Results
- Posted 6 Oct 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Lurasidone HCl is a compound being developed for the treatment of schizophrenia. This clinical study is designed to test the hypothesis that lurasidone is safe and tolerable long term among clinically stable patients. The study will also assess the long term effectiveness of lurasidone as compared to an active comparator.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Lurasidone HClLurasidone |
| 2 | Active comparator | Drug: RisperidoneRisperidone |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Lurasidone HCl40 - 120mg per day | Drug | 1 |
| RisperidoneRisperidone | Drug | 2 |
Primary outcome
Number of Participants With Adverse Events.
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21075600Keefe RS, Fox KH, Harvey PD, Cucchiaro J, Siu C, Loebel A. Characteristics of the MATRICS Consensus Cognitive Battery in a 29-site antipsychotic schizophrenia clinical trial. Schizophr Res. 2011 Feb;125(2-3):161-8. doi: 10.1016/j.schres.2010.09.015. Epub 2010 Dec 31.
- Results publication: PubMed 22395527Citrome L, Cucchiaro J, Sarma K, Phillips D, Silva R, Tsuchiya S, Loebel A. Long-term safety and tolerability of lurasidone in schizophrenia: a 12-month, double-blind, active-controlled study. Int Clin Psychopharmacol. 2012 May;27(3):165-76. doi: 10.1097/YIC.0b013e32835281ef.
- Derived from this study: PubMed 33098548Patel PJ, Weidenfeller C, Jones AP, Nilsson J, Hsu J. Long-Term Assessment of Lurasidone in Schizophrenia: Post Hoc Analysis of a 12-Month, Double Blind, Active-Controlled Trial and 6-Month Open-Label Extension Study. Neurol Ther. 2021 Jun;10(1):121-147. doi: 10.1007/s40120-020-00221-4. Epub 2020 Oct 24.
- Derived from this study: PubMed 32370778Mattingly GW, Haddad PM, Tocco M, Xu J, Phillips D, Pikalov A, Loebel A. Switching to Lurasidone following 12 months of treatment with Risperidone: results of a 6-month, open-label study. BMC Psychiatry. 2020 May 5;20(1):199. doi: 10.1186/s12888-020-02523-1.
- Derived from this study: PubMed 28433500Georgiades A, Davis VG, Atkins AS, Khan A, Walker TW, Loebel A, Haig G, Hilt DC, Dunayevich E, Umbricht D, Sand M, Keefe RSE. Psychometric characteristics of the MATRICS Consensus Cognitive Battery in a large pooled cohort of stable schizophrenia patients. Schizophr Res. 2017 Dec;190:172-179. doi: 10.1016/j.schres.2017.03.040. Epub 2017 Apr 20.
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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.
73 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lurasidone HCl and Risperidone in people with Schizophrenia and Schizoaffective Disorder, run by Sumitomo Pharma America, Inc. at 73 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 22 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 73 sites in United States, South Africa, Argentina, Chile, Israel and 3 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 6 Oct 2011). 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 Adverse Events. (time frame: 12 months). 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 NCT00641745, which also lists 5 linked publications.
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 22 Jun 2015; AzTrials last refreshed its copy on 3 Nov 2026.