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SchizophreniaPhase 3NCT01821378

Lurasidone Low-Dose - High-Dose Study Study

A Phase 3 study testing Lurasidone and Lurasidone 80 mg once daily initially rerandomized either to 80 mg or 160 mg at week 2 in people with Schizophrenia, run by Sumitomo Pharma America, Inc. at 66 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

The primary purpose of this study is to evaluate the efficacy of lurasidone 20 mg/day in subjects with an acute exacerbation of schizophrenia. 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 and Lurasidone 80 mg once daily initially rerandomized either to 80 mg or 160 mg at week 2
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
412 participants
Where
66 sitesin 6 countries
Study dates
May 2013to Jun 2014
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

  • Subject provides written informed consent and is willing and able to comply with the protocol in the opinion of the Investigator.
  • Subject is ≥ 18 and ≤ 75 years of age, on the day of signing the informed consent.
  • Subject meets DSM-IV-TR criteria for a primary diagnosis of schizophrenia [including disorganized (295.10), paranoid (295.30), undifferentiated (295.90) subtypes] as established by clinical interview (using the DSM-IV-TR as a reference and confirmed using the SCID-CT). The duration of the subject's illness whether treated or untreated must be ≥ 6 months.
  • Subject has a PANSS total score ≥ 80 and a PANSS subscale score ≥ 4 (moderate) on 2 or more of the following PANSS subscale items: delusions, conceptual disorganization, hallucinations, and unusual thought content at screening and baseline.
  • Subject has a CGI-S score of ≥ 4 at screening and baseline.
  • Subject has an acute exacerbation of psychotic symptoms (no longer than 2 months) and marked deterioration of function from baseline (by history) or subject has been hospitalized for the purpose of treating an acute psychotic exacerbation for 2 consecutive weeks or less immediately before screening.
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  • Subjects who have been hospitalized for more than 2 weeks for reasons unrelated to acute exacerbation can be included with concurrence from the Medical Monitor that such hospitalization was for a reason other than acute relapse. For example, subjects in a long term hospital setting who have an acute exacerbation and are transferred to an acute unit are eligible for study entry.
  • Subject is not pregnant (must have a negative serum pregnancy test at screening) or nursing (must not be lactating) and is not planning pregnancy within the projected duration of the study.
  • Female subject of reproductive potential agrees to remain abstinent or use adequate and reliable contraception throughout the study and for at least 30 days after the last dose of lurasidone has been taken. In the Investigator's judgment, the subject will adhere to this requirement.
  • Adequate contraception is defined as continuous use of either two barrier methods (eg, condom and spermicide or diaphragm with spermicide) or a hormonal contraceptive. Acceptable hormonal contraceptives include the following: a) contraceptive implant (such as Norplant®) implanted at least 90 days prior to screening; b) injectable contraception (such as medroxyprogesterone acetate injection) given at least 14 days prior to screening; or c) oral contraception taken as directed for at least 30 days prior to screening.
  • Subjects who are of non-reproductive potential, ie, subject who is surgically sterile, has undergone tubal ligation, or is postmenopausal (defined as at least 12 months of spontaneous amenorrhea or between 6 and 12 months of spontaneous amenorrhea with follicle stimulating hormone (FSH) concentrations within postmenopausal range as determined by laboratory analysis) are not required to remain abstinent or use adequate contraception.
  • Subject is able and agrees to remain off prior antipsychotic medication for the duration of the study
  • Subject has had a stable living arrangement at the time of screening and agrees to return to a similar living arrangement after discharge. This criterion is not meant to exclude subjects who have temporarily left a stable living arrangement (eg, due to psychosis). Such subjects remain eligible to participate in this protocol. Chronically homeless subjects should not be enrolled.
  • Subject is in good physical health on the basis of medical history, physical examination, and laboratory screening.
  • Subject who requires concomitant medication treatment with the following agents may be included if they have been on stable doses (ie, minor adjustments only) for the specified times: 1) oral hypoglycemics must be stable for at least 30 days prior to screening, 2) antihypertensive agents must be stable for at least 30 days prior to screening, and 3) thyroid hormone replacement must be stable for at least 90 days prior to screening. (Note: CYP3A4 inducers and inhibitors will not be allowed).
  • Subject is willing and able to comply with the protocol assessments and visits, in the opinion of the study nurse/coordinator and the Investigator.

Who cannot join

  • Subject has a DSM-IV Axis I or Axis II diagnosis, other than schizophrenia, that has been the primary focus of treatment within 3 months of screening.
  • Subject answers "yes" to "Suicidal Ideation" item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) on the C-SSRS assessment at screening (ie, in the past one month) or baseline (ie, since last visit).
  • Subject is considered by the Investigator to be at imminent risk of suicide or injury to self, others, or property.
  • Subject has attempted suicide within 3 months prior to the screening phase.
  • Subject currently has a clinically significant medical condition including the following: neurological, metabolic (including Type 1 diabetes), hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, and/or urological disorder such as unstable angina, congestive heart failure (uncontrolled), or central nervous system (CNS) infection that would pose a risk to the subject if they were to participate in the study or that might confound the results of the study. Subjects with known human immunodeficiency virus (HIV) seropositivity will be excluded.
  • Note:Active medical conditions that are minor or well-controlled are not exclusionary if they do not affect risk to the subject or the study results. In cases in which the impact of the condition upon risk to the subject or study results is unclear, the Medical Monitor should be consulted. Any subject with a known cardiovascular disease or condition (even if controlled) must be discussed with the Medical Monitor during screening.
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  • Subject has evidence of any chronic organic disease of the CNS such as tumors, inflammation, and active seizure disorder, vascular disorder, Parkinson's disease, Alzheimer's disease or other forms of dementia, myasthenia gravis, or other degenerative processes. In addition, subject must not have a history of mental retardation or persistent neurological symptoms attributable to serious head injury. Note: Past history of febrile seizures, drug-induced seizures, or alcohol withdrawal seizures is not exclusionary.
  • Subject demonstrates evidence of acute hepatitis, clinically significant chronic hepatitis, or evidence of clinically significant impaired hepatic function through clinical and laboratory evaluation.
  • Note: Subjects with serum alanine transaminase (ALT) or aspartate transaminase (AST) levels greater than or equal to 3 times the upper limit of the reference ranges provided by the central laboratory require retesting. If on retesting the laboratory value remain greater than or equal to 3 times the upper limit, the subject will be excluded.
  • Subject has a history of stomach or intestinal surgery or any other condition that could interfere with or is judged by the Investigator to interfere with absorption, distribution, metabolism, or excretion of study drug.
  • Subject with Type 1 or Type 2 insulin-dependent diabetes.
  • Subject with newly diagnosed Type 2 diabetes during screening. Subject with Type 2 diabetes is eligible for study inclusion if the following condition is met at screening:
  • if a subject is currently being treated with oral anti-diabetic medication(s), the dose must have been stable for at least 4 weeks prior to screening. Such medication may be adjusted or discontinued during the study, as clinically indicated.
  • -Subject has any abnormal laboratory parameter at screening that indicates a clinically significant medical condition as determined by the Investigator. Subjects with a fasting blood glucose at screening ≥ 126 mg/dL (7.0 mmol/L) or HbA1c ≥ 6.5% will be excluded.
  • Note: Subjects with random (non-fasting) blood glucose at screening ≥ 200 mg/dL (11.1 mmol/L) must be retested in a fasted state.
  • Subject has a prolactin concentration > 100 ng/mL at screening or has a history of pituitary adenoma.
  • Subject has a history of malignancy < 5 years prior to signing the informed consent, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer. Pituitary tumors of any duration are excluded.
  • Subject is judged to be resistant to antipsychotic treatment defined as any one of the following:
  • failure to respond to > 2 marketed antipsychotic agents, given at an adequate dose and for an adequate duration (within the past 2 years)
  • history of treatment with clozapine for refractory psychosis
  • Subject is receiving an antipsychotic medication above the maximum recommended (country-specific) dose at or prior to screening and, in the judgment of the Investigator, is unlikely to respond to standard doses of lurasidone.
  • Subject has received depot antipsychotics unless the last injection was at least one treatment cycle or at least 30 days (whichever is longer), prior to the screening phase.
  • Subject has received treatment with antidepressants within 7 days (fluoxetine hydrochloride within 28 days, MAO inhibitors within 14 days) or clozapine within 120 days prior to the double-blind baseline.
  • Subject requires treatment with any potent CYP3A4 inhibitors or inducers during the study (Appendix 3).
  • Subject has received electroconvulsive therapy treatment within the 3 months prior to screening or is expected to require ECT during the study.
  • Subject has a history of neuroleptic malignant syndrome.
  • Subject exhibits evidence of severe tardive dyskinesia, severe dystonia, or any other severe movement disorder. Severity will be determined by the Investigator.
  • Subject has a history of alcohol or substance abuse (DSM-IV-TR criteria) within 3 months prior to screening or alcohol or substance dependence (DSM-IV-TR criteria) within 12 months prior to screening. The only exceptions include caffeine or nicotine abuse/dependence.
  • Subject tests positive for drugs of abuse at screening, however, a positive test for amphetamines, barbiturates, opiates, benzodiazepines or methadone may not result in exclusion of subjects if the investigator determines that the positive test is as a result of prescription medicine(s). In the event a subject tests positive for cannabinoids (tetrahydrocannabinol), the Investigator will evaluate the subject's ability to abstain from using this substance during the study. This information will be discussed with the Medical Monitor prior to study enrollment.
  • Subject had a history or presence of an abnormal electrocardiogram (ECG), which in the Investigator's opinion is clinically significant (Medical Monitor may be consulted to determine clinical significance).
  • Subject has poor peripheral venous access that will limit the ability to draw blood as judged by the Investigator.
  • Subject has a history of hypersensitivity to more than 2 distinct chemical classes of drug (eg, sulfas and penicillins).
  • Subject was screened or washed out previously more than three times for this study.
  • Subject is currently participating, or has participated in, a study with an investigational or marketed compound or device within 3 months prior to signing the informed consent, or has participated in 2 or more studies within 12 months prior to signing the informed consent.
  • Subject is homeless or did not have a stable residence for the 3 months prior to the screening phase.
  • Subject is unable to cooperate with any study procedures, unlikely to adhere to the study procedures and keep appointments, in the opinion of the Investigator, or was planning to relocate during the study.
  • Subject demonstrates a decrease (improvement) of ≥ 20% in the PANSS total score between screening and baseline visits (use Appendix 6 for calculation), or the PANSS total score falls below 80 at baseline.

Trial locations and contacts

66 sites in 6 countries.

66 sites in 6 countries

United States28 sites

  • Atlanta Center for Medical Research

    Atlanta, Georgia, 30308

  • FutureSearch Clinical Trials, L.P.

    Austin, Texas, 78731

  • Neurobehavioral Research, Inc.

    Cedarhurst, New York, 11516

  • Comprehensive Clinical Development

    Cerritos, California, 90703

  • FutureSearch Trials of Dallas, LP

    Dallas, Texas, 75231

  • Pillar Clinical Research, LLC

    Dallas, Texas, 75243

  • Midwest Clinical Research Center, LLC

    Dayton, Ohio, 45417

  • iResearch Atlanta, LLC

    Decatur, Georgia, 30030

  • Western Affiliated Research Institute

    Denver, Colorado, 80209

  • Synergy Clinical Research of Escondido

    Escondido, California, 92025

  • Comprehensive Clinical Development- Holliswood Hospital

    Holliswood, New York, 11423

  • Bayou Clinical Research, Ltd.

    Houston, Texas, 77007

  • Lake Charles Clinical Trials, LLC

    Lake Charles, Louisiana, 70629

  • Woodland International Research Group, Inc.

    Little Rock, Arkansas, 72211

  • Apostle Clinical Trials, Inc.

    Long Beach, California, 90813

  • Cnri, Llc

    Los Angeles, California, 90660

  • Florida Clinical Research Center, LLC - PARENT

    Maitland, Florida, 32751

  • University of Miami Medical Center

    Miami, Florida, 33136

  • Florida Clinical Research Center, LLC

    Orlando, Florida, 32810

  • Pasadena Research Institute

    Pasadena, California, 91106

  • CRILifetree

    Philadelphia, Pennsylvania, 19139

  • Center for Behavioral Health, LLC

    Rockville, Maryland, 20850

  • St. Charles Psychiatric Associates

    Saint Charles, Missouri, 63301

  • Midwest Research Group

    Saint Charles, Missouri, 63304

  • Cnri, Llc

    San Diego, California, 92102

  • University of California San Diego Medical Center

    San Diego, California, 92103

  • Collaborative Neuroscience Network, Inc.

    Torrance, California, 90502

  • Via Christi Research, a division of Via Christi Hospitals Wichita, Inc.

    Wichita, Kansas, 67214

Other trials in United States

Russia12 sites

  • SHI Arkhangelsk Regional Clinical Psychiatric Hospital

    Arkhangelsk, 163530

  • SHI Reg Clinical Specialized Psychoneurological Hospital #1

    Chelyabinsk

  • Kemerovo Regional Clinical Psychiatric Hospital

    Kemerovo, 650036

  • GUZ Lipetsk Regional psychoneurological Hospital #1

    Lipetsk Region, 399313

  • Moscow Region Psychiatric Hospital #5

    Moscow Region, 142601

  • City Psychiatric Hospital of St. Nikolay Chudotvorets

    Saint Petersburg, 190121

  • City Psychiatric Hospital #4

    Saint Petersburg, 191119

  • FSBI "Bekhterev Psychoneurological Research Institute SPb Russia"

    Saint Petersburg, 192019

  • SPHI "City Mental Hospital #3 n.a. I.I.Skvortsov-Stepanov"

    Saint Petersburg, 197341

  • SBHI "Samara Psychiatric Clinic"

    Samara, 443016

  • MHI City Clinical Hospital #2 named after V.I. Razumovsky

    Saratov, 410028

  • FSBI "Research Institute for Mental Health" of Siberian branch of RAMS

    Tomsk, 634014

Other trials in Russia

Romania9 sites

  • Spitalul Universitar de Urgenta Militar Central "Dr Carol Davila"

    Bucharest, 010825

  • Spitalul de Psihiatrie Titan "Dr Constantin Gorgos"

    Bucharest, 030442

  • Spitalul Clinic de Psihiatrie Prof. Dr. Alexandru Obregia

    Bucharest, 041914

  • Spitalul Clinic de Neuropsihiatrie Craiova

    Craiova, 200473

  • Spitalul Judetean de Urgenta "Sf. Pantelimon" Focsani

    Focşani, 620165

  • Spitalul de Psihiatrie "Elisabeta Doamna"

    Galati, 800179

  • Spitalul Clinic de Psihiatrie Socola

    Iași, 700282

  • Spitalul Judetean de Urgenta Pitesti

    Piteşti, 110069

  • Spitalul Judetean de Urgenta Targoviste

    Targoviste, 130086

Other trials in Romania

Ukraine8 sites

  • Donetsk M. Gorkyi NMU Ch of Psychiatry, Narcology and MP CT&PI RCPsH

    Donetsk, 83008

  • Regional Psychoneurological Hospital #3

    Ivano-Frankivsk, 76014

  • SMPI Central Clinical Hospital of Ukrzaliznytsia

    Kharkiv, 61103

  • CI Kherson Regional Psychiatric Hospital of Kherson RC

    Kherson,Vil. Stepanivka, 73488

  • Kyiv City Clinical Psychoneurological Hospital #1

    Kyiv, 04080

  • Odesa Regional Psychoneurogical Dispensary

    Odesa, 65014

  • SI S.I. Heorhievskyi CSMU Ch of PPN with the Course of G&MP CRI CPH #1

    Simferopol, 95006

  • M.I. Pyrogov VNMU Ch of Psych&Nar BO CI O.I. Yuschenko VRPsH

    Vinnytsia, 21005

Other trials in Ukraine

Slovakia6 sites

  • Nemocnica s poliklinikou Prievidza so sidlom v Bojniciach

    Bojnice, 97201

  • Univerzitna nemocnica Bratislava, Nemocnica Ruzinov

    Brastislava, 82605

  • Psychiatricka nemocnica Hronovce

    Domaša, 93561

  • Psychiatricka nemocnica Michalovce, n.o.

    Michalovce, 071 01

  • Vseobecna nemocnica Rimavska Sobota

    Rimavská Sobota, 97901

  • Nemocnica s poliklinikou sv. Barbory Roznava a.s.

    Rožňava, 04801

Other trials in Slovakia

Colombia3 sites

  • E.S.E. Hospital Mental de Antioquia

    Bello

  • Centro de Investigaciones del Sistema Nervioso Limitada - Grupo CISNE Ltda

    Bogotá

  • Instituto Colombiano del Sistema Nervioso - Clinica Montserrat

    Bogotá

Other trials in Colombia

About this study

Official title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Low-dose Lurasidone in Acutely Psychotic Subjects With Schizophrenia

The primary purpose of this study is to evaluate the efficacy of lurasidone 20 mg/day in subjects with an acute exacerbation of schizophrenia.

Read the detailed description

The primary purpose of this study is to evaluate the efficacy of lurasidone 20 mg/day in subjects with an acute exacerbation of schizophrenia. This study will also evaluate the efficacy and safety of lurasidone 80 mg/day and160 mg/day versus placebo in subjects who are early non-responders (operationally defined per protocol) to lurasidone 80 mg/day.

Conditions
Schizophrenia
Being tested
Lurasidone, Lurasidone 80 mg once daily initially rerandomized either to 80 mg or 160 mg at week 2, Placebo
Keywords
Schizophrenia, Lurasidone, Latuda
Medical subject headings
Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LurasidoneDrug

    Also called Latuda

    Lurasidone 20 mg once daily

  • Lurasidone 80 mg once daily initially rerandomized either to 80 mg or 160 mg at week 2Drug

    Also called Latuda

    Lurasidone 80 mg once daily

  • PlaceboDrug

    Once Daily

Study groups in NCT01821378
Study groupRoleWhat they receive
Lurasidone 20 mgExperimentalLurasidone 20 mg once daily
Receives: Drug: Lurasidone; Drug: Lurasidone 80 mg once daily initially rerandomized either to 80 mg or 160 mg at week 2; Drug: Placebo
Lurasidone 80 mgExperimentalLurasidone 80 mg once daily initially rerandomized either to 80 mg or 160 mg at week 2
Receives: Drug: Lurasidone; Drug: Lurasidone 80 mg once daily initially rerandomized either to 80 mg or 160 mg at week 2; Drug: Placebo
PlaceboPlacebo comparatorPlacebo Comparator 20 or 80 mg once daily
Receives: Drug: Lurasidone; Drug: Lurasidone 80 mg once daily initially rerandomized either to 80 mg or 160 mg at week 2; Drug: Placebo

What is being measured

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

  1. Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6 for Lurasidone 20 mg and 80-160 mg Versus Placebo.

    The PANSS is an interview-based measure of the severity of psychopathology in adults with psychotic disorders. The measure is comprised of 30 items. An anchored Likert scale from 1-7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. The PANSS total score is the sum of all 30 items and ranges from 30 through 210. A higher score is associated with greater illness severity.

    Measured: Baseline to 6 Weeks

Secondary outcomes (8)

  1. Change in Clinical Global Impression-Severity of Illness (CGI-S) Score at Week 6 for Lurasidone 20 mg and 80-160 mg Versus Placebo.

    The CGI-S is a clinician-rated assessment of the subject's current illness state on a 7-point scale (0-7), where a higher score is associated with greater illness severity. Following a clinical interview, the CGI-S can be completed in 1-2 minutes.

    Measured: Baseline to 6 Weeks

  2. Change From Baseline to Week 6 for the Lurasidone 20 mg, and Lurasidone 80 - 160 mg Groups Versus the Placebo Group in the Montgomery-Asberg Depression Rating Scale Total Score

    The MADRS consists of 10 items, each rated on a Likert scale, from 0="Normal" to 6="Most Severe". The MADRS total score is calculated as the sum of the 10 items. The MADRS total score ranges from 0 to 60. Higher scores are associated with greater severity.

    Measured: Baseline to 6 Weeks

  3. Proportion of Subjects Who Achieve a Response, Defined as 20% or Greater Improvement From Baseline in Positive and Negative Syndrome Score (PANSS) Total Score at Week 6

    The PANSS is an interview-based measure of the severity of psychopathology in adults with psychotic disorders. The measure is comprised of 30 items. An anchored Likert scale from 1-7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. The PANSS total score is the sum of all 30 items and ranges from 30 through 210. A higher score is associated with greater illness severity.

    Measured: 6 Weeks

  4. Change From Week 2 to Week 6 for the ENR (Early Non-responders) Lurasidone 160mg Group vs the ENR (Early Non-responders) Lurasidone 80 mg Group in the Following: PANSS Total Score

    The PANSS is an interview-based measure of the severity of psychopathology in adults with psychotic disorders. The measure is comprised of 30 items. An anchored Likert scale from 1-7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. The PANSS total score is the sum of all 30 items and ranges from 30 through 210. A higher score is associated with greater illness severity.

    Measured: week 2 to week 6

  5. Change From Baseline to Week 6 for the ENR Lurasidone 80mg and ENR Lurasidone 160mg Groups vs the Placebo in the MADRS Total Score

    The MADRS consists of 10 items, each rated on a Likert scale, from 0="Normal" to 6="Most Severe". The MADRS total score is calculated as the sum of the 10 items. The MADRS total score ranges from 0 to 60. Higher scores are associated with greater severity.

    Measured: baseline to week 6

  6. Change From Week 2 to Week 6 for ENR Lurasidone 80 mg vs. ENR Lurasidone 160 mg in CGI-S Score

    The CGI-S is a clinician-rated assessment of the subject's current illness state on a 7-point scale (0-7), where a higher score is associated with greater illness severity. Following a clinical interview, the CGI-S can be completed in 1-2 minutes.

    Measured: week 2 to week 6

  7. Change From Baseline to Week 6 for the ENR Lurasidone 80mg and ENR Lurasidone 160mg Groups vs the Placebo in the PANSS Total Score

    The PANSS is an interview-based measure of the severity of psychopathology in adults with psychotic disorders. The measure is comprised of 30 items. An anchored Likert scale from 1-7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. The PANSS total score is the sum of all 30 items and ranges from 30 through 210. A higher score is associated with greater illness severity.

    Measured: Baseline to week 6

  8. Change From Baseline to Week 6 for the ENR Lurasidone 80mg and ENR Lurasidone 160mg Groups vs the Placebo in the CGI-S Score

    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. Following a clinical interview, the CGI-S can be completed in 1-2 minutes.

    Reason for the discrepancy of the LS mean (SE) for placebo in outcome 2 and outcome 9 is because the different MMRM model used in outcome 2 and outcome 9. The treatment groups included in the MMRM model for outcome 2 are placebo, lurasidone 20 mg, and lurasidone 80-160 mg. The treatment groups included in the MMRM model for outcome 9 are placebo, ENR lurasidone 80 mg, and ENR lurasidone 160 mg.

    Measured: baseline to week 6

Timeline

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

  1. First posted1 Apr 2013 (estimated)
  2. Study startMay 2013
  3. Primary completionJun 2014
  4. Study completionJun 2014

Resources

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
412 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01821378
Sponsor's protocol ID
D1050303
Other IDs
2012-005271-14
Status last verified
Jul 2016
First submitted
22 Mar 2013
Last updated
21 Jul 2016
Data monitoring committee
No

Publications

  • Loebel A, Silva R, Goldman R, Watabe K, Cucchiaro J, Citrome L, Kane JM. Lurasidone Dose Escalation in Early Nonresponding Patients With Schizophrenia: A Randomized, Placebo-Controlled Study. J Clin Psychiatry. 2016 Dec;77(12):1672-1680. doi: 10.4088/JCP.16m10698.

    PubMed 27454547

  • Loebel A, Citrome L, Correll CU, Xu J, Cucchiaro J, Kane JM. Treatment of early non-response in patients with schizophrenia: assessing the efficacy of antipsychotic dose escalation. BMC Psychiatry. 2015 Oct 31;15:271. doi: 10.1186/s12888-015-0629-0.

    PubMed 26521019

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lurasidone and Lurasidone 80 mg once daily initially rerandomized either to 80 mg or 160 mg at week 2 in people with Schizophrenia, run by Sumitomo Pharma America, Inc. at 66 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 16 inclusion and 37 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 21 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 66 sites in United States, Russia, Romania, Ukraine, Slovakia 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. 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 8 Jan 2016). 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 From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6 for Lurasidone 20 mg and 80-160 mg Versus Placebo. (time frame: Baseline to 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 NCT01821378, 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 21 Jul 2016.

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