SchizophreniaPhase 3NCT00615433
Lurasidone HCl A Phase 3 Study of Patients With Acute Schizophrenia
A Phase 3 study testing Lurasidone, Olanzapine and Lurasidone 40 mg tablets in people with Schizophrenia, run by Sumitomo Pharma America, Inc. at 52 sites in 5 countries.
Trial summary
Lurasidone HCl is a compound developed for the treatment of schizophrenia. This clinical study is designed to test the hypothesis that lurasidone is more efficacious than placebo. The study will also evaluate the safety and tolerability of lurasidone as compared to placebo. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Lurasidone, Olanzapine and Lurasidone 40 mg tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 478 participants
- Where
- 52 sitesin 5 countries
- Study dates
- Jan 2008to Jan 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
Who may be able to join
- Provide written informed consent and aged between 18 and 75 years of age.
- Meets DSM-IV criteria for a primary diagnosis of schizophrenia.
- Not pregnant, if of reproductive potential agrees to remain abstinent or use adequate and reliable contraception for duration of study.
- Able and agrees to remain off prior antipsychotic medication for the duration of study.
- Good physical health on the basis of medical history, physical examination, and laboratory screening.
- Willing and able to comply with the protocol, including the inpatient requirements and outpatient visits.
Who cannot join
- Considered by the investigator to be at imminent risk of suicide or injury to self, others or property.
- Any chronic organic disease of the CNS (other than schizophrenia).
- Used investigational compound within 30 days.
- Clinically significant or history of alcohol abuse/alcoholism or drug abuse/dependence within the last 6 months
Trial locations and contacts
52 sites in 5 countries.
52 sites in 5 countries
United States25 sites
Atlanta Center for Medical Research
Atlanta, Georgia, 30308
Community Clinical Research, Inc.
Austin, Texas, 78754
Neurobehavioral Research Inc.
Cedarhurst, New York, 11516
Clinical Pharmacological Studies, Inc.
Cerritos, California, 90703
Uptown Research Institute, LLC
Chicago, Illinois, 60640
Precise Research Center
Flowood, Mississippi, 39232
Florida Clinical Research Center, LLC
Fruitland Park, Florida, 24731
Alexian Brothers Health System
Hoffman Estates, Illinois, 60169
Claghorn-Lesem Research Clinic, Inc.
Houston, Texas, 77008
K&S Professional Research Services LLC
Little Rock, Arkansas, 72201
Woodland International Research Group, LLC
Little Rock, Arkansas, 72211
Vanderbilt Heart and Vascular Institute
Nashville, Tennessee, 37212
Keystone Clinical Studies, LLC
Norristown, Pennsylvania, 19401
Segal Institute for Clinical Research
North Miami, Florida, 33161
Excell Research
Oceanside, California, 92056
University of California at Irvine Medical Center
Orange, California, 92868
California Clinical Trials
Paramount, California, 90723
University of North Carolina at Chapel Hill
Raleigh, North Carolina, 27603
St. Charles Psychiatric Associates-Midwest Research
Saint Charles, Missouri, 63301
CNRI - San Diego, LLC
San Diego, California, 92102
UCSD Medical Center
San Diego, California, 92103
Lousiana Clinical Research, LLC
Shreveport, Louisiana, 71104
St. Louis Clinical Trials
St Louis, Missouri, 63118
Collaborative Neuroscience Network Inc.
Torrance, California, 90502
CRI Worldwide @ Lourdes
Willingboro, New Jersey, 08046
India14 sites
Hospital for Mental Health - Dept of Psychiatry
Ahmedabad, Gujarat, 380004
Sheth Vadilal Sarabhai General Hospital
Ahmedabad, Gujarat, 380006
Victoria Hospital
Bangalore, Karna, 56002
Madras Medical College & Government General Hospital
Chennai, Tamil Nadu, 600003
Shanti Nursing Home
Chhatrapati Sambhajinagar, Mahara, 431005
Kasturba Medical College
Mangalore, Karna, 575001
Father Muller Institute of Medical Education and Research
Mangalore, Karna, 575002
Justice K.S. Hedge Charitable Hospital
Mangalore, Karna, 575018
Kasturba Hospital
Manipal, Karna, 576104
JSS Medical College and Hospital - Dept of Psychiatry
Mysore, Karna, 570004
Deenanath Mangeshkar Hospital
Pune, Mahara, 411004
SBKS Medical College and Brij Psychiatry Hospital
Vadodara, Gujarat, 390001
Vijayawada Institute of Mental Health and Neurosciences
Vijaywada, Andh Prad, 520002
Government Hospital for Mental Care
Visakhapatnam, Andh Prad, 530017
Colombia5 sites
CIPNA Centro de Investigaciones y Proyectos en Neurociencias
Barranquilla
Centro de Investigacion y Atencion para la Salud Mental
Bogotá
Centro de Investigaciones del Sistema Nervioso Limitada
Bogotá
Instituto Colombiano del Sistema Nervioso Clinica Montserrat
Cundinamarca, Bogota D.C.
Psynapsis Salud Mental, S.A.
Risaralda
Lithuania4 sites
Ziegzdriai Mental Hospital, Public Institution
Kaunas, 53136
Klaipeda Mental Hospital, Public Institution
Klaipėda, 91251
Siauliai Mental Hospital, Public Institution
Šiauliai, 76231
Republican Vilnius Psychiatry Hospital, Public Institution
Vilnius, 11205
Philippines4 sites
Davao Medical School Foundation Hospital
Davao City, 8000
Makati Medical Center
Makati City, 1227
National Center for Mental Health
Mandaluyong, 1553
Metro Psych Facility
Mandaue City, 6014
About this study
Official title: A Phase 3 Randomized, Placebo-and Active Comparator Controlled, Clinical Trial to Study the Safety and Efficacy of Two Doses of Lurasidone HCl in Acutely Psychotic Patients With Schizophrenia.
Lurasidone HCl is a compound developed for the treatment of schizophrenia. This clinical study is designed to test the hypothesis that lurasidone is more efficacious than placebo. The study will also evaluate the safety and tolerability of lurasidone as compared to placebo.
- Conditions
- Schizophrenia
- Being tested
- Lurasidone, Olanzapine, Placebo comparator, Lurasidone 40 mg tablets
- Keywords
- Schizophrenia, Latuda, Lurasidone
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LurasidoneDrug
120mg/day
OlanzapineDrug
15mg/day
Placebo comparatorDrug
Placebor Comparator
Lurasidone 40 mg tabletsDrug
Lurasidone 40 mg tablets
| Study group | Role | What they receive |
|---|---|---|
| Lurasdione 40mg tablets | Experimental | Not described Receives: Drug: Lurasidone 40 mg tablets |
| 120mg | Experimental | Not described Receives: Drug: Lurasidone |
| 15mg Olz | Active comparator | Not described Receives: Drug: Olanzapine |
| Sugar pill | Placebo comparator | Not described Receives: Drug: Placebo comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Total PANSS (Positive and Negative Syndrome Scale)Score From Baseline to the End of the Double Blind Treatment Period.
The PANSS is a 30-item rating instrument evaluating the presence/absence and severity of positive, negative and general psychopathology of schizophrenia. The scale was developed from the BPRS and the Psychopathology Rating Scale. All 30 items are rated on a 7-point scale (1=absent; 7=extreme). The total score can range from 30 to 210. Lower scores represent less severity of illness.
Measured: Baseline and 6 weeks
Secondary outcomes (1)
CGI-S (Clinical Global Impression - Severity) Change From Baseline to the End of the Double-blind Treatment.
The CGI-S is a clinician-rated assessment of the subject's current illness state on a 7-point scale, where a higher score is associated with greater illness severity.
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 Feb 2008 (estimated)
- Study startJan 2008
- Primary completionDec 2009
- Study completionJan 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 478 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
- NCT00615433
- Sponsor's protocol ID
- D1050231
- Status last verified
- May 2015
- First submitted
- 1 Feb 2008
- Last updated
- 12 Jun 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Meltzer HY, Cucchiaro J, Silva R, Ogasa M, Phillips D, Xu J, Kalali AH, Schweizer E, Pikalov A, Loebel A. Lurasidone in the treatment of schizophrenia: a randomized, double-blind, placebo- and olanzapine-controlled study. Am J Psychiatry. 2011 Sep;168(9):957-67. doi: 10.1176/appi.ajp.2011.10060907. Epub 2011 Jun 15.
PubMed 21676992Stahl SM, Cucchiaro J, Simonelli D, Hsu J, Pikalov A, Loebel A. Effectiveness of lurasidone for patients with schizophrenia following 6 weeks of acute treatment with lurasidone, olanzapine, or placebo: a 6-month, open-label, extension study. J Clin Psychiatry. 2013 May;74(5):507-15. doi: 10.4088/JCP.12m08084. Epub 2013 Mar 13.
PubMed 23541189Hopkins SC, Tomioka S, Ogirala A, Loebel A, Koblan KS, Marder SR. Assessment of Negative Symptoms in Clinical Trials of Acute Schizophrenia: Test of a Novel Enrichment Strategy. Schizophr Bull Open. 2022 Apr 7;3(1):sgac027. doi: 10.1093/schizbullopen/sgac027. eCollection 2022 Jan.
PubMed 39144777Hopkins SC, Ogirala A, Worden M, Koblan KS. Depicting Safety Profile of TAAR1 Agonist Ulotaront Relative to Reactions Anticipated for a Dopamine D2-Based Pharmacological Class in FAERS. Clin Drug Investig. 2021 Dec;41(12):1067-1073. doi: 10.1007/s40261-021-01094-7. Epub 2021 Nov 9.
PubMed 34751928Nasrallah HA, Cucchiaro JB, Mao Y, Pikalov AA, Loebel AD. Lurasidone for the treatment of depressive symptoms in schizophrenia: analysis of 4 pooled, 6-week, placebo-controlled studies. CNS Spectr. 2015 Apr;20(2):140-7. doi: 10.1017/S1092852914000285. Epub 2014 Jun 23.
PubMed 24955752
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 Phase 3 Randomized, Placebo-and Active Comparator Controlled, Clinical Trial to Study the Safety and Efficacy of Two Doses of Lurasidone HCl in Acutely Psychotic Patients With Schizophrenia.
- ClinicalTrials.gov ID
- NCT00615433
- Acronym / sponsor ID
- D1050231
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Latuda, Lurasidone
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 478 participants (actual)
- Lead sponsor
- Sumitomo Pharma America, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 14 Feb 2008 (estimated)
- Results
- Posted 14 Feb 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 developed for the treatment of schizophrenia. This clinical study is designed to test the hypothesis that lurasidone is more efficacious than placebo. The study will also evaluate the safety and tolerability of lurasidone as compared to placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Lurasdione 40mg tablets | Experimental | Drug: Lurasidone 40 mg tablets |
| 120mg | Experimental | Drug: Lurasidone |
| 15mg Olz | Active comparator | Drug: Olanzapine |
| Sugar pill | Placebo comparator | Drug: Placebo comparator |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Provide written informed consent and aged between 18 and 75 years of age.
- Meets DSM-IV criteria for a primary diagnosis of schizophrenia.
- Not pregnant, if of reproductive potential agrees to remain abstinent or use adequate and reliable contraception for duration of study.
- Able and agrees to remain off prior antipsychotic medication for the duration of study.
- Good physical health on the basis of medical history, physical examination, and laboratory screening.
Key exclusion criteria (4 listed)
- Considered by the investigator to be at imminent risk of suicide or injury to self, others or property.
- Any chronic organic disease of the CNS (other than schizophrenia).
- Used investigational compound within 30 days.
- Clinically significant or history of alcohol abuse/alcoholism or drug abuse/dependence within the last 6 months
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 |
|---|---|---|
| Lurasidone120mg/day | Drug | 120mg |
| Olanzapine15mg/day | Drug | 15mg Olz |
| Placebo comparatorPlacebor Comparator | Drug | Sugar pill |
| Lurasidone 40 mg tabletsLurasidone 40 mg tablets | Drug | Lurasdione 40mg tablets |
Primary outcome
Change in Total PANSS (Positive and Negative Syndrome Scale)Score From Baseline to the End of the Double Blind Treatment Period.
Time frame: Baseline and 6 weeks
The PANSS is a 30-item rating instrument evaluating the presence/absence and severity of positive, negative and general psychopathology of schizophrenia. The scale was developed from the BPRS and the Psychopathology Rating Scale. All 30 items are rated on a 7-point scale (1=absent; 7=extreme). The total score can range from 30 to 210. Lower scores represent less severity of illness.
1 secondary outcome
CGI-S (Clinical Global Impression - Severity) Change From Baseline to the End of the Double-blind Treatment.
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 12 Jun 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21676992Meltzer HY, Cucchiaro J, Silva R, Ogasa M, Phillips D, Xu J, Kalali AH, Schweizer E, Pikalov A, Loebel A. Lurasidone in the treatment of schizophrenia: a randomized, double-blind, placebo- and olanzapine-controlled study. Am J Psychiatry. 2011 Sep;168(9):957-67. doi: 10.1176/appi.ajp.2011.10060907. Epub 2011 Jun 15.
- Results publication: PubMed 23541189Stahl SM, Cucchiaro J, Simonelli D, Hsu J, Pikalov A, Loebel A. Effectiveness of lurasidone for patients with schizophrenia following 6 weeks of acute treatment with lurasidone, olanzapine, or placebo: a 6-month, open-label, extension study. J Clin Psychiatry. 2013 May;74(5):507-15. doi: 10.4088/JCP.12m08084. Epub 2013 Mar 13.
- Derived from this study: PubMed 39144777Hopkins SC, Tomioka S, Ogirala A, Loebel A, Koblan KS, Marder SR. Assessment of Negative Symptoms in Clinical Trials of Acute Schizophrenia: Test of a Novel Enrichment Strategy. Schizophr Bull Open. 2022 Apr 7;3(1):sgac027. doi: 10.1093/schizbullopen/sgac027. eCollection 2022 Jan.
- Derived from this study: PubMed 34751928Hopkins SC, Ogirala A, Worden M, Koblan KS. Depicting Safety Profile of TAAR1 Agonist Ulotaront Relative to Reactions Anticipated for a Dopamine D2-Based Pharmacological Class in FAERS. Clin Drug Investig. 2021 Dec;41(12):1067-1073. doi: 10.1007/s40261-021-01094-7. Epub 2021 Nov 9.
- Derived from this study: PubMed 24955752Nasrallah HA, Cucchiaro JB, Mao Y, Pikalov AA, Loebel AD. Lurasidone for the treatment of depressive symptoms in schizophrenia: analysis of 4 pooled, 6-week, placebo-controlled studies. CNS Spectr. 2015 Apr;20(2):140-7. doi: 10.1017/S1092852914000285. Epub 2014 Jun 23.
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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.
52 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lurasidone, Olanzapine and Lurasidone 40 mg tablets in people with Schizophrenia, run by Sumitomo Pharma America, Inc. at 52 sites in 5 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 6 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 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 52 sites in United States, India, Colombia, Lithuania, Philippines. 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. Some participants in this study may receive a placebo. 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 14 Feb 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?
Change in Total PANSS (Positive and Negative Syndrome Scale)Score From Baseline to the End of the Double Blind Treatment Period. (time frame: Baseline and 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 NCT00615433, 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 12 Jun 2015.