SchizophreniaPhase 3Switch ExtNCT01143090
A Study of Subjects Switched to Lurasidone for the Treatment of Schizophrenia or Schizoaffective Disorder
A Phase 3 study testing Lurasidone HCl in people with Schizophrenia and Schizoaffective Disorder, run by Sumitomo Pharma America, Inc. at 27 sites in United States.
Trial summary
Lurasidone (lurasidone HCl) is a novel psychotropic agent that is being developed as a potential new antipsychotic treatment for patients with schizophrenia. Switching between antipsychotic medications is common in the treatment of schizophrenia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder
- What is being tested?
- Lurasidone HCl
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- 27 sitesUnited States
- Study dates
- Aug 2010to Nov 2011
- 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 completed 6 weeks of treatment and all required assessments on the final study visit (Visit 8) of Study D1050289 (NCT01143077).
Who cannot join
- Subject is considered by the investigator to be at imminent risk of suicide or harm to self, others, or damage to property.
- Subject has a body mass index (BMI) greater than 40 or less than 18 kg/m2 (see Appendix 3 for BMI determination).
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
United States27 sites
Comprehensive NeuroScience, Inc.
Atlanta, Georgia, 30328
Medical College of Georgia
Augusta, Georgia, 30912
FutureSearch Clinical Trials, LP
Austin, Texas, 78731
Neurobehavioral Research, Inc.
Cedarhurst, New York, 11516
University of Illinois at Chicago
Chicago, Illinois, 60612
FutureSearch Trials of Dallas
Dallas, Texas, 75231
Pillar Clinical Research, LLC
Dallas, Texas, 75243
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Western Affiliated Research Institute
Denver, Colorado, 80204
Duke University Dept. of Psychiatry
Durham, North Carolina, 27710
Synergy Clinical Research of Escondido
Escondido, California, 92025
Collaborative Neuroscience Network, Inc.
Garden Grove, California, 92845
The Zucker Hillside Hospital
Glen Oaks, New York, 11004
Lake Charles Clinical Trials
Lake Charles, Louisiana, 70601
K and S Professional Research Services
Little Rock, Arkansas, 72201
Pacific Research Partners, LLC
Oakland, California, 94612
California Clinical Trials
Paramount, California, 90723
Pasadena Research Institute
Pasadena, California, 91107
CRI Worldwide - Kirkbride Center
Philadelphia, Pennsylvania, 19139
California Neuropsychopharmacology Clinical Research Institute (CNRI), LLC
Pico Rivera, California, 90660
St. Charles Psychiatric Associates - Midwest Research
Saint Charles, Missouri, 63301
University of Utah School of Medicine
Salt Lake City, Utah, 84132
California Neuropsychopharmacology Clinical Research Institute (CNRI)
San Diego, California, 92102
University of California San Diego Medical Center
San Diego, California, 92103-8218
Collaborative Neuroscience Network, South Bay
Torrance, California, 90502
Wharton Research Center
Wharton, Texas, 77488
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, 27157
About this study
Official title: A 24-Week, Flexible-Dose, Open-label Extension Study of Subjects Switched to Lurasidone for the Treatment of Schizophrenia or Schizoaffective Disorder (Protocol No. D1050290)
Lurasidone (lurasidone HCl) is a novel psychotropic agent that is being developed as a potential new antipsychotic treatment for patients with schizophrenia. Switching between antipsychotic medications is common in the treatment of schizophrenia. The purpose of this study is to characterize the long-term safety and tolerability of lurasidone in subjects with schizophrenia or schizoaffective disorder and to allow for continued treatment for subjects completing the core study (D1050289-NCT01143077).
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Being tested
- Lurasidone HCl
- Keywords
- Schizophrenia, Lurasidone, 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 mg Lurasidone tablets, 40 - 120 mg per day for up to 6 months
| Study group | Role | What they receive |
|---|---|---|
| Open Label | Experimental | Subjects will continue on treatment with the same dose of lurasidone flexible dosing - 40 mg to 12 mg once daily taken orallay at endpoint of the D1050289 ( NCT01143077) core study. Receives: Drug: Lurasidone HCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Proportions of subjects with AEs, SAEs, and discontinuations due to AEs.
Measured: 6 months
Secondary outcomes (1)
Efficacy
Long-term efficacy of lurasidone in subjects with schizophrenia or schizoaffective disorder who have completed Study D1050289
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2010 (estimated)
- Study startAug 2010
- Primary completionNov 2011
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 (2)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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 149 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
- NCT01143090
- Sponsor's protocol ID
- D1050290
- Acronym
- Switch Ext
- Status last verified
- May 2015
- First submitted
- 10 Jun 2010
- Last updated
- 12 Jun 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Citrome L, Weiden PJ, McEvoy JP, Correll CU, Cucchiaro J, Hsu J, Loebel A. Effectiveness of lurasidone in schizophrenia or schizoaffective patients switched from other antipsychotics: a 6-month, open-label, extension study. CNS Spectr. 2014 Aug;19(4):330-9. doi: 10.1017/S109285291300093X. Epub 2013 Dec 16.
PubMed 24330868Awad G, Ng-Mak D, Rajagopalan K, Hsu J, Pikalov A, Loebel A. Long-term health-related quality of life improvements among patients treated with lurasidone: results from the open-label extension of a switch trial in schizophrenia. BMC Psychiatry. 2016 Jun 1;16:176. doi: 10.1186/s12888-016-0879-5.
PubMed 27245981
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 24-Week, Flexible-Dose, Open-label Extension Study of Subjects Switched to Lurasidone for the Treatment of Schizophrenia or Schizoaffective Disorder (Protocol No. D1050290)
- ClinicalTrials.gov ID
- NCT01143090
- Acronym / sponsor ID
- Switch Ext / D1050290
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Keywords
- Schizophrenia, Lurasidone, Latuda
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Sumitomo Pharma America, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Nov 2011 (actual)
- First posted
- 14 Jun 2010 (estimated)
- Results
- Posted 17 Dec 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Lurasidone (lurasidone HCl) is a novel psychotropic agent that is being developed as a potential new antipsychotic treatment for patients with schizophrenia. Switching between antipsychotic medications is common in the treatment of schizophrenia. The purpose of this study is to characterize the long-term safety and tolerability of lurasidone in subjects with schizophrenia or schizoaffective disorder and to allow for continued treatment for subjects completing the core study (D1050289-NCT01143077).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open Label | Experimental | Drug: Lurasidone HClSubjects will continue on treatment with the same dose of lurasidone flexible dosing - 40 mg to 12 mg once daily taken orallay at endpoint of the D1050289 ( NCT01143077) core study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subject has completed 6 weeks of treatment and all required assessments on the final study visit (Visit 8) of Study D1050289 (NCT01143077).
Key exclusion criteria (2 listed)
- Subject is considered by the investigator to be at imminent risk of suicide or harm to self, others, or damage to property.
- Subject has a body mass index (BMI) greater than 40 or less than 18 kg/m2 (see Appendix 3 for BMI determination).
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 mg Lurasidone tablets, 40 - 120 mg per day for up to 6 months | Drug | Open Label |
Primary outcome
Adverse Events
Time frame: 6 months
Proportions of subjects with AEs, SAEs, and discontinuations due to AEs.
1 secondary outcome
Efficacy
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24330868Citrome L, Weiden PJ, McEvoy JP, Correll CU, Cucchiaro J, Hsu J, Loebel A. Effectiveness of lurasidone in schizophrenia or schizoaffective patients switched from other antipsychotics: a 6-month, open-label, extension study. CNS Spectr. 2014 Aug;19(4):330-9. doi: 10.1017/S109285291300093X. Epub 2013 Dec 16.
- Derived from this study: PubMed 27245981Awad G, Ng-Mak D, Rajagopalan K, Hsu J, Pikalov A, Loebel A. Long-term health-related quality of life improvements among patients treated with lurasidone: results from the open-label extension of a switch trial in schizophrenia. BMC Psychiatry. 2016 Jun 1;16:176. doi: 10.1186/s12888-016-0879-5.
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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.
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lurasidone HCl in people with Schizophrenia and Schizoaffective Disorder, run by Sumitomo Pharma America, Inc. at 27 sites in United States.
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 1 inclusion and 2 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 12 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 27 sites in United States. 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 17 Dec 2012). 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?
Adverse Events (time frame: 6 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 NCT01143090, which also lists 2 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 12 Jun 2015.