SchizophreniaPhase 3SWITCHCoreNCT01143077
A Study Evaluating Lurasidone for The Treatment of Schizophrenia or Schizoaffective Disorder in Subjects Switched From Other Antipsychotic Agents
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
- 244 participants
- Where
- 27 sitesUnited States
- Study dates
- Jun 2010to May 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 ≥ 18 years of age.
- Subject meets DSM-IV criteria for a primary diagnosis of schizophrenia or schizoaffective disorder.
- Subject must be judged by the investigator to be an appropriate candidate for switching current antipsychotic medication due to insufficient efficacy and/or safety or tolerability concerns.
Who cannot join
- Presence of an Axis I or Axis II disorder other than schizophrenia or schizoaffective disorder that is the primary focus of treatment prior to screening.
- Subject has experienced persistent lack of improvement in psychotic symptoms despite adequate trials (at least 6 weeks at standard doses), of two or more antipsychotic agents in the 12 months prior to screening.
- Subject is considered by the investigator to be at imminent risk of suicide or harm to self, others, or property. Subject has suicidal ideation at baseline or has attempted suicide within 90 days prior to randomization (even without hospitalization).
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, 75390-8828
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
Wharton Research Center
Houston, Texas, 77488
Lake Charles Clinical Trials, LLC
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, 19131
California Neuropsychopharmacology Clinical Research Institute (CNRI), LLC
Pico Rivera, California, 90660
Saint Charles Psychiatric Associates/Midwest Research Group
Saint Charles, Missouri, 63301
University of Utah Hospitals and Clinics
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
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: A Randomized, 6-week, Open-Label, Study Evaluating The Safety, Tolerability, and Efficacy of Lurasidone for The Treatment of Schizophrenia or Schizoaffective Disorder in Subjects Switched From Other Antipsychotic Agents
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 current study is designed to evaluate the effectiveness, safety, and tolerability of switching clinically stable, but symptomatic outpatients with schizophrenia or schizoaffective disorder from their preswitch antipsychotic medication to lurasidone, over a period of 6 weeks.
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Being tested
- Lurasidone HCl
- 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
Also called Latuda
Lurasidone tablets, 40 mg/daily, 80 mg/daily, 120 mg/daily for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Lurasidone Open-Label Arm A | Experimental | Not described Receives: Drug: Lurasidone HCl |
| Lurasidone Open-Label Arm B | Experimental | Not described Receives: Drug: Lurasidone HCl |
| Lurasidone Open-Label Arm C | Experimental | Not described Receives: Drug: Lurasidone HCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Relapse of Psychotic Symptoms During 6 Weeks
Relapse is defined as any occurrence of:
- Insufficient clinical response
- Exacerbation of underlying disease
- Discontinuation due to an adverse event
Measured: 6 Weeks
Secondary outcomes (1)
Tolerability and Safety
Number of participants with Treatment Emergent Adverse Events and Serious Adverse Events
Measured: 6 Weeks
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 startJun 2010
- Primary completionMay 2011
- Study completionMay 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 244 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
- NCT01143077
- Sponsor's protocol ID
- D1050289
- Acronym
- SWITCHCore
- Status last verified
- Apr 2013
- First submitted
- 10 Jun 2010
- Last updated
- 17 Apr 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
McEvoy JP, Citrome L, Hernandez D, Cucchiaro J, Hsu J, Pikalov A, Loebel A. Effectiveness of lurasidone in patients with schizophrenia or schizoaffective disorder switched from other antipsychotics: a randomized, 6-week, open-label study. J Clin Psychiatry. 2013 Feb;74(2):170-9. doi: 10.4088/JCP.12m07992.
PubMed 23473350Awad G, Hassan M, Loebel A, Hsu J, Pikalov A, Rajagopalan K. Health-related quality of life among patients treated with lurasidone: results from a switch trial in patients with schizophrenia. BMC Psychiatry. 2014 Feb 23;14:53. doi: 10.1186/1471-244X-14-53.
PubMed 24559217
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, 6-week, Open-Label, Study Evaluating The Safety, Tolerability, and Efficacy of Lurasidone for The Treatment of Schizophrenia or Schizoaffective Disorder in Subjects Switched From Other Antipsychotic Agents
- ClinicalTrials.gov ID
- NCT01143077
- Acronym / sponsor ID
- SWITCHCore / D1050289
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Keywords
- Lurasidone, Schizophrenia, Latuda
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 244 participants (actual)
- Lead sponsor
- Sumitomo Pharma America, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 14 Jun 2010 (estimated)
- Results
- Posted 16 Aug 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 current study is designed to evaluate the effectiveness, safety, and tolerability of switching clinically stable, but symptomatic outpatients with schizophrenia or schizoaffective disorder from their preswitch antipsychotic medication to lurasidone, over a period of 6 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lurasidone Open-Label Arm A | Experimental | Drug: Lurasidone HCl |
| Lurasidone Open-Label Arm B | Experimental | Drug: Lurasidone HCl |
| Lurasidone Open-Label Arm C | Experimental | Drug: Lurasidone HCl |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject ≥ 18 years of age.
- Subject meets DSM-IV criteria for a primary diagnosis of schizophrenia or schizoaffective disorder.
- Subject must be judged by the investigator to be an appropriate candidate for switching current antipsychotic medication due to insufficient efficacy and/or safety or tolerability concerns.
Key exclusion criteria (3 listed)
- Presence of an Axis I or Axis II disorder other than schizophrenia or schizoaffective disorder that is the primary focus of treatment prior to screening.
- Subject has experienced persistent lack of improvement in psychotic symptoms despite adequate trials (at least 6 weeks at standard doses), of two or more antipsychotic agents in the 12 months prior to screening.
- Subject is considered by the investigator to be at imminent risk of suicide or harm to self, others, or property. Subject has suicidal ideation at baseline or has attempted suicide within 90 days prior to randomization (even without hospitalization).
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 HClAlso: LatudaLurasidone tablets, 40 mg/daily, 80 mg/daily, 120 mg/daily for 6 weeks | Drug | Lurasidone Open-Label Arm A, Lurasidone Open-Label Arm B, Lurasidone Open-Label Arm C |
Primary outcome
Time to Relapse of Psychotic Symptoms During 6 Weeks
Time frame: 6 Weeks
Relapse is defined as any occurrence of: * Insufficient clinical response * Exacerbation of underlying disease * Discontinuation due to an adverse event
1 secondary outcome
Tolerability and Safety
Time frame: 6 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23473350McEvoy JP, Citrome L, Hernandez D, Cucchiaro J, Hsu J, Pikalov A, Loebel A. Effectiveness of lurasidone in patients with schizophrenia or schizoaffective disorder switched from other antipsychotics: a randomized, 6-week, open-label study. J Clin Psychiatry. 2013 Feb;74(2):170-9. doi: 10.4088/JCP.12m07992.
- Derived from this study: PubMed 24559217Awad G, Hassan M, Loebel A, Hsu J, Pikalov A, Rajagopalan K. Health-related quality of life among patients treated with lurasidone: results from a switch trial in patients with schizophrenia. BMC Psychiatry. 2014 Feb 23;14:53. doi: 10.1186/1471-244X-14-53.
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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.
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 3 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 17 Apr 2013. 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 16 Aug 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?
Time to Relapse of Psychotic Symptoms During 6 Weeks (time frame: 6 Weeks). 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 NCT01143077, 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 17 Apr 2013.