Chronic SchizophreniaPhase 3PEARL 3 ExtNCT00789698

Lurasidone HCl - A Long Term Phase 3 Study of Patients With Chronic Schizophrenia

A Phase 3 study testing Lurasidone HC1 and Quetiapine XR in people with Chronic Schizophrenia, run by Sumitomo Pharma America, Inc. at 65 sites in 6 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 effective, tolerable, and safe as compared with quetiapine XR long term among schizophrenic outpatients with chronic schizophrenia. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Chronic Schizophrenia
What is being tested?: Lurasidone HC1 and Quetiapine XR
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 240 participants
Where: 65 sitesin 6 countries
Study dates: Dec 2008to Jul 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 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Completed all required assessments on the final study visit in Study D1050233.
Suitable for treatment in an outpatient setting.

Who cannot join

Any chronic organic disease of the CNS (other than schizophrenia).
Considered by the investigator to be at imminent risk of suicide or injury to self, others, or property.

Trial locations and contacts

65 sites in 6 countries.

Country

City, postcode or hospital

65 sites in 6 countries

United States27 sites

Community Clinical Research
Austin, Texas, 78729
FutureSearch Clinical Trials, LLC.
Austin, Texas, 78756
Florida Clinical Research Center LLC
Bradenton, Florida, 34208
SUNY Downstate Medical Center
Brooklyn, New York, 11238
Comprehensive Neuroscience, Inc
Cerritos, California, 90703
Clinical Innovations, Inc.
Costa Mesa, California, 92647
Pillar Clinical Research
Dallas, Texas, 75243
Synergy Escondido,710 East Grand Ave.
Escondido, California, 92025
Collaborative Neuroscience Network Inc
Garden Grove, California, 92645
Segal Institute for Clinical Research
Highlands Ranch, Colorado, 80103
Comprehensive Neuroscience, Inc
Holliswood, New York, 11423
Lake Charles Clinical Trials LLC,2770 3rd Avenue,Suite 340
Lake Charles, Louisiana, 70601
K&S Professional Research Services, LLC
Little Rock, Arkansas, 72201
Woodland International Research Group
Little Rock, Arkansas, 72211
Apostle Clinical Trials, Inc.
Long Beach, California, 90813
California Clinical Trials
Paramount, California, 90723
Pasadena Research Institute
Pasadena, California, 91107
CNRI - Los Angeles LLC,8309 Telegraph Road
Pico Rivera, California, 90660
CNRI- LOs Angeles, LLC
Pico Rivera, California, 90660
Clinical Innovations, Inc.
Riverside, California, 92647
St. Charles Psychiatric Associates
Saint Charles, Missouri, 63301
CNRI - San Diego
San Diego, California, 92102
UCSD Medical Drive
Sandeigo, California, 92103
Booker, J. Gary, MD. APMC
Shreveport, Louisiana, 71104
St. Louis Research, Inc.
St Louis, Missouri, 63118
Comprehensive Neuroscience, Inc.
Washington D.C., District of Columbia, 20016
CRI Worldwide
Willingboro, New Jersey, 08046

Other trials in United States

India10 sites

Seth K M School of P G Medicine & Research
Ahmedabad, Gujarat, 380006
Madras Medical College & Government General Hospital
Chennai, Tamil Nadu, 600003
Shanti Nursing Home
Kanchanpalli, Aurangabad, Maharashtra
Justice K.S. Hedge Charitable Hospital
Mangalore, Karna, 574160
JSS Medical College and Hospital - Dept of Psychiatry
Mysore, Karna, 570004
Deenanath Mangeshkar Hospital and Research Centre
Pune, Maharashtra, 411004
Mahatma Gandhi Institute of Medical Sciences
Sewāgrām, Maharashtra
S.V. Medical College
Tirupati, Andhra Pradesh, 517507
SBKS Medical College and Hospital, Brij Psychiatry Hospital
Vadodara, Gujarat, 390001
Vijayawada Institute of Mental Health and Neurosciences
Vijayawada, Andhra Pradesh, 520002

Other trials in India

Russia9 sites

Andreev, Boris
Gatchina
Gurovich, Isaak
Moscow
Morozova, Margarita
Moscow
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
City Psychiatric Hospital #3 of Skvortsov-Stepanov
Saint Petersburg, 197341
Neznanov, Nikolay
Saint Petersburg
Sheifer, Mikhail
Samara

Other trials in Russia

Ukraine8 sites

Dnipropetrovsk Regional Clinical Hospital named Mechnikov
Dnipropetrovsk, 49005
Reg.Clin.Psychiatric Hosp., Dept. #11, DSMU n.af.M.Gorkiy
Donetsk, 83037
Kyiv City Clin. Psychoneurolog. Hosp.#1
Kyiv, 04080
Kyiv City Psychoneurological Hospital
Kyviv
Lviv Reg.St.Cl.Psych.Hosp
Lviv
Reg. Psychiatric Hospital
Odesa
Crimean republican Clinical Psychiatric Hospital
Simferopol
Kherson Regional Psychiatric Hospital
Vil. Stepanovka, Kherson, 73488

Other trials in Ukraine

Colombia6 sites

Centro de Investigaciones y Proyectos en Neurociencias CIPNA
Barranquilla
Centro de Investigación y Atención para la Salud Mental
Bogotá
CISNE - UIC Campo Abierto
Bogotá
Instituto Colombiano del Sistema Nervioso Clínica Montserrat
Bogotá
Centro de Investigacion y Atencion para la Salud Mental
Calle 103A # 21-49, Bogota S/N
CIPNA Centro de Investigaciones y Proyectos en Neurociencias
Calle 80#47-43 Consultorio 5C, Barranquila S/N

Other trials in Colombia

Romania5 sites

Spitalul Clinic de Psihiatrie Prof. Dr. Alexandru Obregia
Bucharest
Spitalul Clinic de Neurologie si Psihiatrie Oradea
Oradea
Spitalul Judetean Arges
Piteşti, 110069
Spitalul Clinic de Psihiatrie Prof. Dr. Alexandru Obregia
Sos. Berceni Nr. 10-12, Bucharest, 041914
Spitalul Clinic Judetean de Urgenta Arad
Str. Octavian Goga Nr. 17, Arad, 310022

Other trials in Romania

About this study

Official title: A Phase 3 Randomized, Double-Blind, Active Comparator-Controlled Clinical Trial to Study the Safety and Efficacy of Lurasidone in Subjects With Schizophrenia (PEARL 3 Extension Study)

Conditions: Chronic Schizophrenia
Being tested: Lurasidone HC1, Quetiapine XR
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 HC1Drug
Lurasidone 40-160 mg/day flexibly dosed.
Quetiapine XRDrug
Quetiapine XR 200-800 mg/day flexibly dosed.

Study groups in NCT00789698
Study group	Role	What they receive
Lurasidone HC1	Experimental	Not described Receives: Drug: Lurasidone HC1
Quetiapine	Active comparator	Not described Receives: Drug: Quetiapine XR

What is being measured

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

Relapse of Psychotic Symptoms
Time to relapse will be defined as the earliest occurrence of any of the following:
- Worsening of >= 30% positive and negative syndrome scale total score from NCT00790192 and clinical global impression-severity sub-scale >=3
- rehospitalization for worsening of psychosis
- emergence of suicidal ideation, homicidal ideation and/or risk of harm to self or others Comparison of time to relapse of psychotic symptoms between lurasidone and quetiapine XR after 1 year as analyzed using the Cox proportional hazard model with country as a covariate.
Measured: 12 Months

Secondary outcomes (3)

Change From the Acute Phase Baseline to Month 6 of the Double-blind Treatment in the CogState Computerized Cognitive Scores.
The battery has seven outcome measures that measure the cognitive constructs. The seven domains are: detection, identification, one back task, international shopping list task, one card learning task, Groton maze learning task and social emotional matching. The standardized scores for each subject at each assessment will then be averaged to yield a composite score. There are no maximum or minimum values, however a higher score indicates improved performance on the cognitive constructs. The change score is change from baseline to month 6.
Measured: Baseline and 6 Months
Change From the Acute Phase Baseline to the End (Month 12) of the Double-blind Treatment in the Positive and Negative Syndrome Scale (PANSS)
The PANSS is an interview-based measure of psychopathology severity in adults with psychotic disorders. Thirty items are rated using a Likert scale, from 1 - 7. The PANSS total score is the sum of thirty items ranging from 30 to 210 (higher score representing a worsening in psychosis).
Measured: Baseline and 12 months
Change From the Acute Phase Baseline to the End (Month 12) of the Double-blind Treatment in the Clinical Global Impression Severity Scale (CGI-S) Scores
The CGI-S is a clinician-rated assessment of the subject's current illness state on a scale ranging from 1-7, where a higher score is associated with greater illness severity.
Measured: Baseline and 12 months

Timeline

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

Dec 2008Jul 2011

First posted13 Nov 2008 (estimated)
Study startDec 2008
Primary completionJul 2011
Study completionJul 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 (3)Papers the sponsor has linked to this study.
Other trials for Chronic 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: 240 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00789698
Sponsor's protocol ID: D1050234
Acronym: PEARL 3 Ext
Status last verified: May 2015
First submitted: 10 Nov 2008
Last updated: 12 Jun 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Loebel A, Cucchiaro J, Xu J, Sarma K, Pikalov A, Kane JM. Effectiveness of lurasidone vs. quetiapine XR for relapse prevention in schizophrenia: a 12-month, double-blind, noninferiority study. Schizophr Res. 2013 Jun;147(1):95-102. doi: 10.1016/j.schres.2013.03.013. Epub 2013 Apr 11.
PubMed 23583011
Harvey PD, Siu CO, Hsu J, Cucchiaro J, Maruff P, Loebel A. Effect of lurasidone on neurocognitive performance in patients with schizophrenia: a short-term placebo- and active-controlled study followed by a 6-month double-blind extension. Eur Neuropsychopharmacol. 2013 Nov;23(11):1373-82. doi: 10.1016/j.euroneuro.2013.08.003. Epub 2013 Aug 27.
PubMed 24035633
Harvey PD, Siu CO, Ogasa M, Loebel A. Effect of lurasidone dose on cognition in patients with schizophrenia: post-hoc analysis of a long-term, double-blind continuation study. Schizophr Res. 2015 Aug;166(1-3):334-8. doi: 10.1016/j.schres.2015.06.008. Epub 2015 Jun 24.
PubMed 26117157

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?

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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, Double-Blind, Active Comparator-Controlled Clinical Trial to Study the Safety and Efficacy of Lurasidone in Subjects With Schizophrenia (PEARL 3 Extension Study)
ClinicalTrials.gov ID: NCT00789698
Acronym / sponsor ID: PEARL 3 Ext / D1050234
Conditions: Chronic Schizophrenia
Keywords: Schizophrenia, SM-13496, Latuda, Lurasidone
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 240 participants (actual)
Lead sponsor: Sumitomo Pharma America, Inc.Industry (pharma, biotech, devices)
Study start: Dec 2008
Primary completion: Jul 2011 (actual)
Study completion: Jul 2011 (actual)
First posted: 13 Nov 2008 (estimated)
Results: Posted 21 Aug 2012

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: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Lurasidone HC1	Experimental	Drug: Lurasidone HC1
Quetiapine	Active comparator	Drug: Quetiapine XR

Who may qualify

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

Key inclusion criteria (2 listed)

Completed all required assessments on the final study visit in Study D1050233.
Suitable for treatment in an outpatient setting.

Key exclusion criteria (2 listed)

Any chronic organic disease of the CNS (other than schizophrenia).
Considered by the investigator to be at imminent risk of suicide or injury to self, others, or property.

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 HC1Lurasidone 40-160 mg/day flexibly dosed.	Drug	Lurasidone HC1
Quetiapine XRQuetiapine XR 200-800 mg/day flexibly dosed.	Drug	Quetiapine

Primary outcome

Relapse of Psychotic Symptoms
Time frame: 12 Months
Time to relapse will be defined as the earliest occurrence of any of the following: * Worsening of >= 30% positive and negative syndrome scale total score from NCT00790192 and clinical global impression-severity sub-scale >=3 * rehospitalization for worsening of psychosis * emergence of suicidal ideation, homicidal ideation and/or risk of harm to self or others Comparison of time to relapse of psychotic symptoms between lurasidone and quetiapine XR after 1 year as analyzed using the Cox proportional hazard model with country as a covariate.

3 secondary outcomes

Change From the Acute Phase Baseline to Month 6 of the Double-blind Treatment in the CogState Computerized Cognitive Scores.
Time frame: Baseline and 6 Months
Change From the Acute Phase Baseline to the End (Month 12) of the Double-blind Treatment in the Positive and Negative Syndrome Scale (PANSS)
Time frame: Baseline and 12 months
Change From the Acute Phase Baseline to the End (Month 12) of the Double-blind Treatment in the Clinical Global Impression Severity Scale (CGI-S) Scores
Time frame: Baseline and 12 months

Results and safety

Results posted to the registry on 21 Aug 2012, 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 80mg	72	32
Lurasidone 160 mg	79	46
Placebo-Lurasidone	56	29
Quetiapine-Quetiapine	85	33

Primary outcome: Relapse of Psychotic Symptoms

Time frame: 12 Months. Number. Unit: participants

Measure	Lurasidone-Lurasidone n = 139	Quetiapine-Quetiapine n = 79
Value	29	21 (1 to 1)

Lurasidone-Lurasidone vs Quetiapine-Quetiapine: Hazard Ratio (HR): 0.728 (95% CI 0.410 to 1.295), COX Proportional Hazards Model

Population analysed: The population for relapse analyses is the relapse population which consists of those subjects who are enrolled in the present study, demonstrated response to 6 weeks of treatment with either lurasidone or quetiapine XR in study D1050233-NCT 00790192, and who took at least one dose of study medication in the present study.

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lurasidone 80mg	9 of 72 (12.5%)	44 of 72 (61.1%)	Not reported
Lurasidone 160 mg	6 of 79 (7.6%)	51 of 79 (64.6%)	Not reported
Placebo-Lurasidone	2 of 56 (3.6%)	35 of 56 (62.5%)	Not reported
Quetiapine-Quetiapine	17 of 85 (20%)	53 of 85 (62.4%)	Not reported

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 23583011Loebel A, Cucchiaro J, Xu J, Sarma K, Pikalov A, Kane JM. Effectiveness of lurasidone vs. quetiapine XR for relapse prevention in schizophrenia: a 12-month, double-blind, noninferiority study. Schizophr Res. 2013 Jun;147(1):95-102. doi: 10.1016/j.schres.2013.03.013. Epub 2013 Apr 11.
Results publication: PubMed 24035633Harvey PD, Siu CO, Hsu J, Cucchiaro J, Maruff P, Loebel A. Effect of lurasidone on neurocognitive performance in patients with schizophrenia: a short-term placebo- and active-controlled study followed by a 6-month double-blind extension. Eur Neuropsychopharmacol. 2013 Nov;23(11):1373-82. doi: 10.1016/j.euroneuro.2013.08.003. Epub 2013 Aug 27.
Derived from this study: PubMed 26117157Harvey PD, Siu CO, Ogasa M, Loebel A. Effect of lurasidone dose on cognition in patients with schizophrenia: post-hoc analysis of a long-term, double-blind continuation study. Schizophr Res. 2015 Aug;166(1-3):334-8. doi: 10.1016/j.schres.2015.06.008. Epub 2015 Jun 24.

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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.

65 sites in 6 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lurasidone HC1 and Quetiapine XR in people with Chronic Schizophrenia, run by Sumitomo Pharma America, Inc. at 65 sites in 6 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 2 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 65 sites in United States, India, Russia, Ukraine, Colombia and 1 more country. 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 21 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?

Relapse of Psychotic Symptoms (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 NCT00789698, which also lists 3 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.