Lurasidone Low-Dose - High-Dose Study Study

NCT01821378 | Completed Phase 3 Results

• 2 other identifiers: D10503032012-005271-14
• Study Type: interventional
• Target: 412
• Locations: 6 countries
• Sites: 66

Brief 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.

Conditions

Schizophrenia

Keywords

Schizophrenia; Lurasidone; Latuda

Outcome Measures

Primary Outcomes (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.

  Baseline to 6 Weeks

Secondary Outcomes (8)

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

  Baseline to 6 Weeks

• 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

  Baseline to 6 Weeks

• 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

  6 Weeks

• 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

  week 2 to week 6

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

  baseline to week 6

Other Outcomes (2)

• Change From Baseline to Week 6 for the Lurasidone 20 mg and Lurasidone 80 - 160 mg Groups Compared to the Placebo Group in the GAF Score

  6 Weeks

• Change From Baseline to Week 6 for the Lurasidone 20 mg and Lurasidone 80 - 160 mg Groups Compared to the Placebo Group in the Euroqol (EQ-5D) Index Score

  6 weeks

Study Arms (3)

Lurasidone 20 mg

EXPERIMENTAL

Lurasidone 20 mg once daily

Drug: Lurasidone; Drug: Lurasidone 80 mg once daily initially rerandomized either to 80 mg or 160 mg at week 2; Drug: Placebo

Lurasidone 80 mg

EXPERIMENTAL

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

Drug: Lurasidone; Drug: Lurasidone 80 mg once daily initially rerandomized either to 80 mg or 160 mg at week 2; Drug: Placebo

Placebo

PLACEBO COMPARATOR

Placebo Comparator 20 or 80 mg once daily

Drug: Lurasidone; Drug: Lurasidone 80 mg once daily initially rerandomized either to 80 mg or 160 mg at week 2; Drug: Placebo

Interventions

Lurasidone DRUG

Lurasidone 20 mg once daily

Also known as: Latuda

Lurasidone 20 mg; Lurasidone 80 mg; Placebo

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

Lurasidone 80 mg once daily

Also known as: Latuda

Lurasidone 20 mg; Lurasidone 80 mg; Placebo

Placebo DRUG

Once Daily

Lurasidone 20 mg; Lurasidone 80 mg; Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• 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.
• 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:

Sponsors & Collaborators

• Sumitomo Pharma America, Inc.: lead

Study Sites (66)

Woodland International Research Group, Inc.

Little Rock, Arkansas, 72211, United States

Location

Comprehensive Clinical Development

Cerritos, California, 90703, United States

Location

Synergy Clinical Research of Escondido

Escondido, California, 92025, United States

Location

Apostle Clinical Trials, Inc.

Long Beach, California, 90813, United States

Location

Cnri, Llc

Los Angeles, California, 90660, United States

Location

Pasadena Research Institute

Pasadena, California, 91106, United States

Location

Cnri, Llc

San Diego, California, 92102, United States

Location

University of California San Diego Medical Center

San Diego, California, 92103, United States

Location

Collaborative Neuroscience Network, Inc.

Torrance, California, 90502, United States

Location

Western Affiliated Research Institute

Denver, Colorado, 80209, United States

Location

Florida Clinical Research Center, LLC - PARENT

Maitland, Florida, 32751, United States

Location

University of Miami Medical Center

Miami, Florida, 33136, United States

Location

Florida Clinical Research Center, LLC

Orlando, Florida, 32810, United States

Location

Atlanta Center for Medical Research

Atlanta, Georgia, 30308, United States

Location

iResearch Atlanta, LLC

Decatur, Georgia, 30030, United States

Location

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

Wichita, Kansas, 67214, United States

Location

Lake Charles Clinical Trials, LLC

Lake Charles, Louisiana, 70629, United States

Location

Center for Behavioral Health, LLC

Rockville, Maryland, 20850, United States

Location

St. Charles Psychiatric Associates

Saint Charles, Missouri, 63301, United States

Location

Midwest Research Group

Saint Charles, Missouri, 63304, United States

Location

Neurobehavioral Research, Inc.

Cedarhurst, New York, 11516, United States

Location

Comprehensive Clinical Development- Holliswood Hospital

Holliswood, New York, 11423, United States

Location

Midwest Clinical Research Center, LLC

Dayton, Ohio, 45417, United States

Location

CRILifetree

Philadelphia, Pennsylvania, 19139, United States

Location

FutureSearch Clinical Trials, L.P.

Austin, Texas, 78731, United States

Location

FutureSearch Trials of Dallas, LP

Dallas, Texas, 75231, United States

Location

Pillar Clinical Research, LLC

Dallas, Texas, 75243, United States

Location

Bayou Clinical Research, Ltd.

Houston, Texas, 77007, United States

Location

E.S.E. Hospital Mental de Antioquia

Bello, Colombia

Location

Centro de Investigaciones del Sistema Nervioso Limitada - Grupo CISNE Ltda

Bogotá, Colombia

Location

Instituto Colombiano del Sistema Nervioso - Clinica Montserrat

Bogotá, Colombia

Location

Spitalul Universitar de Urgenta Militar Central "Dr Carol Davila"

Bucharest, 010825, Romania

Location

Spitalul de Psihiatrie Titan "Dr Constantin Gorgos"

Bucharest, 030442, Romania

Location

Spitalul Clinic de Psihiatrie Prof. Dr. Alexandru Obregia

Bucharest, 041914, Romania

Location

Spitalul Clinic de Neuropsihiatrie Craiova

Craiova, 200473, Romania

Location

Spitalul Judetean de Urgenta "Sf. Pantelimon" Focsani

Focşani, 620165, Romania

Location

Spitalul de Psihiatrie "Elisabeta Doamna"

Galati, 800179, Romania

Location

Spitalul Clinic de Psihiatrie Socola

Iași, 700282, Romania

Location

Spitalul Judetean de Urgenta Pitesti

Piteşti, 110069, Romania

Location

Spitalul Judetean de Urgenta Targoviste

Târgovişte, 130086, Romania

Location

SHI Arkhangelsk Regional Clinical Psychiatric Hospital

Arkhangelsk, 163530, Russia

Location

SHI Reg Clinical Specialized Psychoneurological Hospital #1

Chelyabinsk, Russia

Location

Kemerovo Regional Clinical Psychiatric Hospital

Kemerovo, 650036, Russia

Location

GUZ Lipetsk Regional psychoneurological Hospital #1

Lipetsk Region, 399313, Russia

Location

Moscow Region Psychiatric Hospital #5

Moscow Region, 142601, Russia

Location

City Psychiatric Hospital of St. Nikolay Chudotvorets

Saint Petersburg, 190121, Russia

Location

City Psychiatric Hospital #4

Saint Petersburg, 191119, Russia

Location

FSBI "Bekhterev Psychoneurological Research Institute SPb Russia"

Saint Petersburg, 192019, Russia

Location

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

Saint Petersburg, 197341, Russia

Location

SBHI "Samara Psychiatric Clinic"

Samara, 443016, Russia

Location

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

Saratov, 410028, Russia

Location

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

Tomsk, 634014, Russia

Location

Nemocnica s poliklinikou Prievidza so sidlom v Bojniciach

Bojnice, 97201, Slovakia

Location

Univerzitna nemocnica Bratislava, Nemocnica Ruzinov

Brastislava, 82605, Slovakia

Location

Psychiatricka nemocnica Hronovce

Domaša, 93561, Slovakia

Location

Psychiatricka nemocnica Michalovce, n.o.

Michalovce, 071 01, Slovakia

Location

Vseobecna nemocnica Rimavska Sobota

Rimavská Sobota, 97901, Slovakia

Location

Nemocnica s poliklinikou sv. Barbory Roznava a.s.

Rožňava, 04801, Slovakia

Location

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

Donetsk, 83008, Ukraine

Location

Regional Psychoneurological Hospital #3

Ivano-Frankivsk, 76014, Ukraine

Location

SMPI Central Clinical Hospital of Ukrzaliznytsia

Kharkiv, 61103, Ukraine

Location

CI Kherson Regional Psychiatric Hospital of Kherson RC

Kherson,Vil. Stepanivka, 73488, Ukraine

Location

Kyiv City Clinical Psychoneurological Hospital #1

Kyiv, 04080, Ukraine

Location

Odesa Regional Psychoneurogical Dispensary

Odesa, 65014, Ukraine

Location

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

Simferopol, 95006, Ukraine

Location

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

Vinnytsia, 21005, Ukraine

Location

Related Publications (2)

• 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.

  PMID: 27454547 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.

  PMID: 26521019 DERIVED

MeSH Terms

Conditions

Schizophrenia

Interventions

Lurasidone Hydrochloride

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: 1-866-503-6351
• Organization: Sunovion

clinicaltrialdisclosure@sunvion.com

1-866-503-6351

Study Officials

• Lurasidone Medical Director

  Sumitomo Pharma America, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2013
• First Posted: April 1, 2013
• Study Start: May 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: July 21, 2016
• Results First Posted: January 8, 2016

Record last verified: 2016-07

Locations

US (28); RO (9); RU (12); SL (6); CO (3); UA (8)