Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
412 participants
Study Classification
INTERVENTIONAL
Study Start Date
2013-05-31
Study Completion Date
2014-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The primary purpose of this study is to evaluate the efficacy of lurasidone 20 mg/day in subjects with an acute exacerbation of schizophrenia.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study Evaluating Lurasidone for The Treatment of Schizophrenia or Schizoaffective Disorder in Subjects Switched From Other Antipsychotic Agents
NCT01143077
Schizophrenia
Schizoaffective Disorder
COMPLETED
PHASE3
Lurasidone HCl: A Phase 3 Study of Patients With Acute Schizophrenia
NCT00549718
Schizophrenia
COMPLETED
PHASE3
A Clinical Trial of Lurasidone in Treatment of Schizophrenia
NCT02002832
Schizophrenia
COMPLETED
PHASE3
Lurasidone HCl - A Long Term Safety Phase 3 Study of Patients With Clinically Stable Schizophrenia
NCT00641745
Schizophrenia
Schizoaffective Disorder
COMPLETED
PHASE3
Lurasidone Extended Use Study
NCT01485640
Schizophrenia
Bipolar Disorder
COMPLETED
PHASE3
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Schizophrenia
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Lurasidone 20 mg
Lurasidone 20 mg once daily
Group Type
EXPERIMENTAL
Lurasidone
Intervention Type
DRUG
Lurasidone 20 mg once daily
Lurasidone 80 mg once daily initially rerandomized either to 80 mg or 160 mg at week 2
Intervention Type
DRUG
Lurasidone 80 mg once daily
Placebo
Intervention Type
DRUG
Once Daily
Lurasidone 80 mg
Lurasidone 80 mg once daily initially rerandomized either to 80 mg or 160 mg at week 2
Group Type
EXPERIMENTAL
Lurasidone
Intervention Type
DRUG
Lurasidone 20 mg once daily
Lurasidone 80 mg once daily initially rerandomized either to 80 mg or 160 mg at week 2
Intervention Type
DRUG
Lurasidone 80 mg once daily
Placebo
Intervention Type
DRUG
Once Daily
Placebo
Placebo Comparator 20 or 80 mg once daily
Group Type
PLACEBO_COMPARATOR
Lurasidone
Intervention Type
DRUG
Lurasidone 20 mg once daily
Lurasidone 80 mg once daily initially rerandomized either to 80 mg or 160 mg at week 2
Intervention Type
DRUG
Lurasidone 80 mg once daily
Placebo
Intervention Type
DRUG
Once Daily
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Lurasidone
Lurasidone 20 mg once daily
Intervention Type
DRUG
Lurasidone 80 mg once daily initially rerandomized either to 80 mg or 160 mg at week 2
Lurasidone 80 mg once daily
Intervention Type
DRUG
Placebo
Once Daily
Intervention Type
DRUG
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Latuda
Latuda
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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.
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.
* 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.
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.
Exclusion Criteria
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.
* 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:
1. failure to respond to \> 2 marketed antipsychotic agents, given at an adequate dose and for an adequate duration (within the past 2 years)
2. 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.
* 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.
* 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:
1. failure to respond to \> 2 marketed antipsychotic agents, given at an adequate dose and for an adequate duration (within the past 2 years)
2. 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.
Minimum Eligible Age
18 Years
Maximum Eligible Age
75 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sumitomo Pharma America, Inc.
INDUSTRY
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Responsibility Role
SPONSOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Lurasidone Medical Director
Role: STUDY_DIRECTOR
Sumitomo Pharma America, Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Woodland International Research Group, Inc.
Little Rock, Arkansas, United States
Site Status
Comprehensive Clinical Development
Cerritos, California, United States
Site Status
Synergy Clinical Research of Escondido
Escondido, California, United States
Site Status
Apostle Clinical Trials, Inc.
Long Beach, California, United States
Site Status
Cnri, Llc
Los Angeles, California, United States
Site Status
Pasadena Research Institute
Pasadena, California, United States
Site Status
Cnri, Llc
San Diego, California, United States
Site Status
University of California San Diego Medical Center
San Diego, California, United States
Site Status
Collaborative Neuroscience Network, Inc.
Torrance, California, United States
Site Status
Western Affiliated Research Institute
Denver, Colorado, United States
Site Status
Florida Clinical Research Center, LLC - PARENT
Maitland, Florida, United States
Site Status
University of Miami Medical Center
Miami, Florida, United States
Site Status
Florida Clinical Research Center, LLC
Orlando, Florida, United States
Site Status
Atlanta Center for Medical Research
Atlanta, Georgia, United States
Site Status
iResearch Atlanta, LLC
Decatur, Georgia, United States
Site Status
Via Christi Research, a division of Via Christi Hospitals Wichita, Inc.
Wichita, Kansas, United States
Site Status
Lake Charles Clinical Trials, LLC
Lake Charles, Louisiana, United States
Site Status
Center for Behavioral Health, LLC
Rockville, Maryland, United States
Site Status
St. Charles Psychiatric Associates
Saint Charles, Missouri, United States
Site Status
Midwest Research Group
Saint Charles, Missouri, United States
Site Status
Neurobehavioral Research, Inc.
Cedarhurst, New York, United States
Site Status
Comprehensive Clinical Development- Holliswood Hospital
Holliswood, New York, United States
Site Status
Midwest Clinical Research Center, LLC
Dayton, Ohio, United States
Site Status
CRILifetree
Philadelphia, Pennsylvania, United States
Site Status
FutureSearch Clinical Trials, L.P.
Austin, Texas, United States
Site Status
FutureSearch Trials of Dallas, LP
Dallas, Texas, United States
Site Status
Pillar Clinical Research, LLC
Dallas, Texas, United States
Site Status
Bayou Clinical Research, Ltd.
Houston, Texas, United States
Site Status
E.S.E. Hospital Mental de Antioquia
Bello, , Colombia
Site Status
Centro de Investigaciones del Sistema Nervioso Limitada - Grupo CISNE Ltda
Bogotá, , Colombia
Site Status
Instituto Colombiano del Sistema Nervioso - Clinica Montserrat
Bogotá, , Colombia
Site Status
Spitalul Universitar de Urgenta Militar Central "Dr Carol Davila"
Bucharest, , Romania
Site Status
Spitalul de Psihiatrie Titan "Dr Constantin Gorgos"
Bucharest, , Romania
Site Status
Spitalul Clinic de Psihiatrie Prof. Dr. Alexandru Obregia
Bucharest, , Romania
Site Status
Spitalul Clinic de Neuropsihiatrie Craiova
Craiova, , Romania
Site Status
Spitalul Judetean de Urgenta "Sf. Pantelimon" Focsani
Focşani, , Romania
Site Status
Spitalul de Psihiatrie "Elisabeta Doamna"
Galati, , Romania
Site Status
Spitalul Clinic de Psihiatrie Socola
Iași, , Romania
Site Status
Spitalul Judetean de Urgenta Pitesti
Piteşti, , Romania
Site Status
Spitalul Judetean de Urgenta Targoviste
Târgovişte, , Romania
Site Status
SHI Arkhangelsk Regional Clinical Psychiatric Hospital
Arkhangelsk, , Russia
Site Status
SHI Reg Clinical Specialized Psychoneurological Hospital #1
Chelyabinsk, , Russia
Site Status
Kemerovo Regional Clinical Psychiatric Hospital
Kemerovo, , Russia
Site Status
GUZ Lipetsk Regional psychoneurological Hospital #1
Lipetsk Region, , Russia
Site Status
Moscow Region Psychiatric Hospital #5
Moscow Region, , Russia
Site Status
City Psychiatric Hospital of St. Nikolay Chudotvorets
Saint Petersburg, , Russia
Site Status
City Psychiatric Hospital #4
Saint Petersburg, , Russia
Site Status
FSBI "Bekhterev Psychoneurological Research Institute SPb Russia"
Saint Petersburg, , Russia
Site Status
SPHI "City Mental Hospital #3 n.a. I.I.Skvortsov-Stepanov"
Saint Petersburg, , Russia
Site Status
SBHI "Samara Psychiatric Clinic"
Samara, , Russia
Site Status
MHI City Clinical Hospital #2 named after V.I. Razumovsky
Saratov, , Russia
Site Status
FSBI "Research Institute for Mental Health" of Siberian branch of RAMS
Tomsk, , Russia
Site Status
Nemocnica s poliklinikou Prievidza so sidlom v Bojniciach
Bojnice, , Slovakia
Site Status
Univerzitna nemocnica Bratislava, Nemocnica Ruzinov
Brastislava, , Slovakia
Site Status
Psychiatricka nemocnica Hronovce
Domaša, , Slovakia
Site Status
Psychiatricka nemocnica Michalovce, n.o.
Michalovce, , Slovakia
Site Status
Vseobecna nemocnica Rimavska Sobota
Rimavská Sobota, , Slovakia
Site Status
Nemocnica s poliklinikou sv. Barbory Roznava a.s.
Rožňava, , Slovakia
Site Status
Donetsk M. Gorkyi NMU Ch of Psychiatry, Narcology and MP CT&PI RCPsH
Donetsk, , Ukraine
Site Status
Regional Psychoneurological Hospital #3
Ivano-Frankivsk, , Ukraine
Site Status
SMPI Central Clinical Hospital of Ukrzaliznytsia
Kharkiv, , Ukraine
Site Status
CI Kherson Regional Psychiatric Hospital of Kherson RC
Kherson,Vil. Stepanivka, , Ukraine
Site Status
Kyiv City Clinical Psychoneurological Hospital #1
Kyiv, , Ukraine
Site Status
Odesa Regional Psychoneurogical Dispensary
Odesa, , Ukraine
Site Status
SI S.I. Heorhievskyi CSMU Ch of PPN with the Course of G&MP CRI CPH #1
Simferopol, , Ukraine
Site Status
M.I. Pyrogov VNMU Ch of Psych&Nar BO CI O.I. Yuschenko VRPsH
Vinnytsia, , Ukraine
Site Status
Countries
Review the countries where the study has at least one active or historical site.
United States
Colombia
Romania
Russia
Slovakia
Ukraine
References
Explore related publications, articles, or registry entries linked to this study.
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2012-005271-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D1050303
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
A Study to Determine the Maximum Tolerated Dose of an Investigational Drug in Subjects With Schizophrenia
NCT03627195
COMPLETED
PHASE1
The Safety and Efficacy of Lurasidone In Subjects With Schizophrenia Switched From Olanzapine
NCT05213143
TERMINATED
PHASE4
A Study to Test the Safety and Tolerability of a New Medication in the Treatment of Schizophrenia
NCT00088621
COMPLETED
PHASE2
Study of SM-13496 (Lurasidone HCl) in Patients With Schizophrenia
NCT00711269
COMPLETED
PHASE3
A Twelve Week, Open Label Extension Study in Patients With Schizophrenia
NCT01566162
COMPLETED
PHASE3
Pediatric Schizophrenia Efficacy and Safety Study
NCT01911429
COMPLETED
PHASE3
The Safety and Efficacy of Lurasidone With Different Initiation Dose in Chinese Acute Phase Patients With Schizophrenia
NCT05011669
COMPLETED
PHASE4
Efficacy of Lu 31-130 in Patients With Schizophrenia
NCT00770744
COMPLETED
PHASE2
Lurasidone HCl - A Long Term Phase 3 Study of Patients With Chronic Schizophrenia
NCT00789698
COMPLETED
PHASE3
Efficacy of Lu AF35700 in Patients With Early-in-disease or Late-in-disease Treatment-resistant Schizophrenia
NCT03230864
TERMINATED
PHASE3
A Study in Schizophrenia Patients
NCT01086748
COMPLETED
PHASE2
Effect of Lu AF35700 in Patients With Treatment-resistant Schizophrenia
NCT02717195
COMPLETED
PHASE3
Lurasidone Effects on Tissue Glutamate in Schizophrenia
NCT02199743
COMPLETED
PHASE4
A Six-week, Randomized, Double-blind, Placebo-controlled, Parallel Group, Multi-center, Phase II Study
NCT00567710
COMPLETED
PHASE2
Long-term Extension Study of SM-13496 (Lurasidone HCl) in Patients With Schizophrenia
NCT01614912
COMPLETED
PHASE3
Flexible-dose, Long-term Safety Study of Lu AF35700 in Adult Patients With Schizophrenia
NCT02892422
COMPLETED
PHASE3
Extension Study To Evaluate The Long-Term Safety, Tolerability, And Efficacy Of Low And High Doses Of Bl-1020
NCT00722176
COMPLETED
PHASE2
A Safety Study Comparing LY2140023 to Atypical Antipsychotic Standard Treatment in Schizophrenic Patients
NCT00845026
COMPLETED
PHASE2
A Study of Aripiprazole Lauroxil in Subjects With Schizophrenia or Schizoaffective Disorder
NCT02636842
COMPLETED
PHASE1
A Randomized Double-blind Trial With 6 Antipsychotic Drugs for Schizophrenia
NCT02192723
COMPLETED
NA
A Study of Extended Release Extended-release (ER) OROS Paliperidone Tolerability, as Compared to Immediate-release (IR)Risperidone, in Patients With Schizophrenia
NCT00791232
COMPLETED
PHASE1
A Study of MK-5720 in Participants With Schizophrenia (MK-5720-001)
NCT05953740
COMPLETED
PHASE1
Dose-response Study to Evaluate Safety, Efficacy, and Pharmacokinetics of PF-00217830 Compared With Placebo in Acute Exacerbation of Schizophrenia
NCT00580125
COMPLETED
PHASE2
A Study to Assess the Safety and Efficacy of ASP4345 as Add-on Treatment for Cognitive Impairment in Subjects With Schizophrenia on Stable Doses of Antipsychotic Medication
NCT03557931
COMPLETED
PHASE2
Safety and Efficacy of Seroquel in First Episode Schizophrenia
NCT00254241
COMPLETED
PHASE4