SchizophreniaPhase 3NCT00549718

Lurasidone HCl: A Phase 3 Study of Patients With Acute Schizophrenia

A Phase 3 study testing Lurasidone HCl in people with Schizophrenia, run by Sumitomo Pharma America, Inc. at 48 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

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 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 HCl
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 489 participants
Where: 48 sitesin 7 countries
Study dates: Oct 2007to Oct 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

To be eligible to enter the study, each patient must comply with the following inclusion criteria:
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

48 sites in 7 countries.

Country

City, postcode or hospital

48 sites in 7 countries

United States21 sites

Atlanta Center for Medical Research
Atlanta, Georgia, 30308
Future Search Trials of Neurology
Austin, Texas, 78756
Florida Clinical Research Center, LLC
Bradenton, Florida, 34208
SUNY Downstate Medical Center
Brooklyn, New York, 11203
Erie County Medical Center, Corp
Buffalo, New York, 14215
Comprehensive Neuroscience, Inc
Cerritos, California, 90703
Clinical Innovations, Inc.
Costa Mesa, California, 92647
Collaborative Neuroscience Network Inc.,12772 Valley View Street,Suite 3
Garden Grove, California, 92645
Alexian Brothers Health System
Hoffman Estates, Illinois, 60169
Lake Charles Clinical Trials LLC
Lake Charles, Louisiana, 70601
K&S Professional Research Services, LLC.
Little Rock, Arkansas, 72201
Research Strategies of Memphis, LLC.
Memphis, Tennessee, 38119
Segal Institute for Clinical Research, Fidelity Clinical Research, Inc.
North Miami, Florida, 33161
California Clinical Trials
Paramount, California, 90723
Pasadena Research Institute
Pasadena, California, 91107
CRI Worldwide LLC at Kirkbride
Philadelphia, Pennsylvania, 19139
California Neuropsychopharmacology,CNRI - Los Angeles LLC,8309 Telegraph Road
Pico Rivera, California, 90660
Center for Behavioral Health, LLC
Rockville, Maryland, 20850
Sharp Mesa Vista Hospital
San Diego, California, 92123
Booker, J. Gary, MD. APMC
Shreveport, Louisiana, 71104
Comprehensive Neuroscience, Inc.
Washington D.C., District of Columbia, 20016

Other trials in United States

Russia7 sites

North State Medical University
Arkhangelsk, 163060
Republic Psychiatric Hospital
Karelia, 111111
City Psychoneurological Dispensary #7 (with Hospital)
Saint Petersburg, 190005
City Psyhiatric Hospital #2 of St. Nikolay Chudotvorets
Saint Petersburg, 190121
City Psychiatric Hospital #4
Saint Petersburg, 191119
Bekhterev Psychoneurological Research Institute
Saint Petersburg, 193019
City Psychiatric Hospital #3 of Skvortsov-Stepanov
Saint Petersburg, 197341

Other trials in Russia

India6 sites

Sheth Vadilal Sarabhai General Hospital
Ahmedabad, Gujarat, 380006
Shanti Nursing Home
Aurangabad, Mahara, 431005
Madras Medical College & Government General Hospital
Chennai, Tamil Nadu, 600003
S V Medical College
Tirupati, Andh Prad, 517507
Deva Mental Health Care
Varanasi, Uttar Prad, 221005
Government Hospital for Mental Care
Visakhapatnam, Andh Prad, 530017

Other trials in India

Ukraine6 sites

Dnipropetrovsk Regional Clinical Hospital named Mechnikov
Dnipropetrovsk, 49005
Reg. Clin. Psychiatric Hosp. DSMU n.af.M.Gorkiy
Donetsk, 83037
Kyiv City Clin. Psychoneurolog. Hosp.#1
Kyiv, 04080
Lv. St. Med. Univ. n. af. D. Halytskiy Oblast Clin. Psychon. Hosp
Lviv, 79021
Odesa SMU, based on Odessa Reg. Psychiatric Hosp.#1
Odesa, 65006
Kherson Regional Psychiatric Hospital
Vil. Stepanovka, Kherson, 73488

Other trials in Ukraine

Romania5 sites

Spitalul Clinic Judetean de Urgenta Arad
Arad, 310022
Spitalul de Psihiatrie Titan "Dr. Constantin Gorgos"
Bucharest, 030442
Spitalul Clinic de Psihiatrie Prof. Dr. Alexandru Obregia
Bucharest, 041914
Centrul de Recuperare si Reabilitare Gura Ocnitei
Gura Ocniței, 130083
Spitalul Judetean Arges
Piteşti, 110069

Other trials in Romania

Malaysia2 sites

Hospital Permai
Johor Bahru, Johor, 81200
University Malaya Medical Centre
Kuala Lumpur, 59100

Other trials in Malaysia

France1 site

Hospital Caremeau
Nîmes, 30000

Other trials in France

About this study

Official title: A Phase 3 Randomized, Placebo-Controlled, CLinical Trial to Study the Safety and Efficacy of Three Doses of Lurasidone HCl in Acutely Psychotic Patients With Schizophrenia

Conditions: Schizophrenia
Being tested: Lurasidone HCl
Keywords: Schizophrenia, SM-13496, 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.

Lurasidone HClDrug
Once daily

Study groups in NCT00549718
Study group	Role	What they receive
Lurasidone 40mg	Experimental	Not described Receives: Drug: Lurasidone HCl
Lurasidone 80mg	Experimental	Not described Receives: Drug: Lurasidone HCl
Lurasidone 120mg	Experimental	Not described Receives: Drug: Lurasidone HCl
Sugar Pill	Placebo comparator	Not described Receives: Drug: Lurasidone HCl

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Total PANSS Score From Baseline to the End of the Double Blind Phase
The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.
Measured: 6 weeks

Secondary outcomes (1)

CGI-S From Baseline to the End of the Double-blind Treatment
Clinical Global Impression of Severity 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. The scale has a single item measured on a 7 point scale from 1 ('normal', not ill) to 7 (extremely ill).
Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2007Oct 2010

First posted26 Oct 2007 (estimated)
Study startOct 2007
Primary completionOct 2010
Study completionOct 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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 489 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00549718
Sponsor's protocol ID: D1050229
Other IDs: 2007-003819-31
Status last verified: Jun 2014
First submitted: 24 Oct 2007
Last updated: 11 Jun 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Nasrallah HA, Silva R, Phillips D, Cucchiaro J, Hsu J, Xu J, Loebel A. Lurasidone for the treatment of acutely psychotic patients with schizophrenia: a 6-week, randomized, placebo-controlled study. J Psychiatr Res. 2013 May;47(5):670-7. doi: 10.1016/j.jpsychires.2013.01.020. Epub 2013 Feb 17.
PubMed 23421963
Hopkins 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 39144777
Hopkins 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 34751928
Correll CU, Cucchiaro J, Silva R, Hsu J, Pikalov A, Loebel A. Long-term safety and effectiveness of lurasidone in schizophrenia: a 22-month, open-label extension study. CNS Spectr. 2016 Oct;21(5):393-402. doi: 10.1017/S1092852915000917. Epub 2016 Apr 6.
PubMed 27048911
Nasrallah 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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 11 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3 Randomized, Placebo-Controlled, CLinical Trial to Study the Safety and Efficacy of Three Doses of Lurasidone HCl in Acutely Psychotic Patients With Schizophrenia
ClinicalTrials.gov ID: NCT00549718
Acronym / sponsor ID: D1050229
Conditions: Schizophrenia
Keywords: Schizophrenia, SM-13496, Latuda, Lurasidone
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 489 participants (actual)
Lead sponsor: Sumitomo Pharma America, Inc.Industry (pharma, biotech, devices)
Study start: Oct 2007
Primary completion: Oct 2010 (actual)
Study completion: Oct 2010 (actual)
First posted: 26 Oct 2007 (estimated)
Results: Posted 14 Dec 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Lurasidone 40mg	Experimental	Drug: Lurasidone HCl
Lurasidone 80mg	Experimental	Drug: Lurasidone HCl
Lurasidone 120mg	Experimental	Drug: Lurasidone HCl
Sugar Pill	Placebo comparator	Drug: Lurasidone HCl

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

To be eligible to enter the study, each patient must comply with the following inclusion criteria:
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.

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
Lurasidone HClOnce daily	Drug	Lurasidone 120mg, Lurasidone 40mg, Lurasidone 80mg, Sugar Pill

Primary outcome

Change in Total PANSS Score From Baseline to the End of the Double Blind Phase
Time frame: 6 weeks
The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.

1 secondary outcome

CGI-S From Baseline to the End of the Double-blind Treatment
Time frame: 6 weeks

Results and safety

Results posted to the registry on 14 Dec 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Lurasidone 40mg	125	84
Lurasidone 80mg	123	86
Lurasidone 120mg	124	85
Placebo	128	73

Primary outcome: Change in Total PANSS Score From Baseline to the End of the Double Blind Phase

Time frame: 6 weeks. Least squares mean (95% Confidence Interval). Unit: scores on a scale

Measure	Lurasidone 40mg n = 121	Lurasidone 80mg n = 118	Lurasidone 120mg n = 123	Placebo n = 124
Value	-19.2 (-22.6 to -15.7)	-23.4 (-26.9 to -19.9)	-20.5 (-24.0 to -17.1)	-17.0 (-20.5 to -13.6)

Lurasidone 40mg vs Lurasidone 80mg vs Lurasidone 120mg vs Placebo: p <0.05, Mixed Models Analysis

Population analysed: The primary population for the efficacy analysis was the Intent-to-Treat (ITT) population. All subjects who were randomized, received at least one dose of study medication, and have a Baseline efficacy measurement and at least one post-Baseline efficacy measurement, were in the efficacy analysis in the treatment group to which they were randomized.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 14 days post study therapy. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lurasidone 40mg	2 of 124 (1.6%)	96 of 124 (77.4%)	Not reported
Lurasidone 80mg	3 of 121 (2.5%)	90 of 121 (74.4%)	Not reported
Lurasidone 120mg	6 of 124 (4.8%)	106 of 124 (85.5%)	Not reported
Placebo	5 of 127 (3.9%)	85 of 127 (66.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 23421963Nasrallah HA, Silva R, Phillips D, Cucchiaro J, Hsu J, Xu J, Loebel A. Lurasidone for the treatment of acutely psychotic patients with schizophrenia: a 6-week, randomized, placebo-controlled study. J Psychiatr Res. 2013 May;47(5):670-7. doi: 10.1016/j.jpsychires.2013.01.020. Epub 2013 Feb 17.
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 27048911Correll CU, Cucchiaro J, Silva R, Hsu J, Pikalov A, Loebel A. Long-term safety and effectiveness of lurasidone in schizophrenia: a 22-month, open-label extension study. CNS Spectr. 2016 Oct;21(5):393-402. doi: 10.1017/S1092852915000917. Epub 2016 Apr 6.
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.

48 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 HCl in people with Schizophrenia, run by Sumitomo Pharma America, Inc. at 48 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 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 11 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 48 sites in United States, Russia, India, Ukraine, Romania 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. 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 Dec 2010). 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 Score From Baseline to the End of the Double Blind Phase (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 NCT00549718, 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 11 Jun 2014; AzTrials last refreshed its copy on 7 Nov 2026.