Lurasidone HCl: A Phase 3 Study of Patients With Acute Schizophrenia
A Phase 3 Randomized, Placebo-Controlled, CLinical Trial to Study the Safety and Efficacy of Three Doses of Lurasidone HCl in Acutely Psychotic Patients With Schizophrenia
2 other identifiers
interventional
489
7 countries
48
Brief Summary
Lurasidone HCl is a compound being developed for the treatment of schizophrenia. This clinical study is designed to test the hypothesis that lurasidone is more efficacious than placebo. The study will also evaluate the safety and tolerability of lurasidone as compared to placebo.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 schizophrenia
Started Oct 2007
Typical duration for phase_3 schizophrenia
48 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2007
CompletedFirst Submitted
Initial submission to the registry
October 24, 2007
CompletedFirst Posted
Study publicly available on registry
October 26, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2010
CompletedResults Posted
Study results publicly available
December 14, 2010
CompletedJune 11, 2014
June 1, 2014
3 years
October 24, 2007
November 8, 2010
June 5, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Total PANSS Score From Baseline to the End of the Double Blind Phase
The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.
6 weeks
Secondary Outcomes (1)
CGI-S From Baseline to the End of the Double-blind Treatment
6 weeks
Study Arms (4)
Lurasidone 40mg
EXPERIMENTALLurasidone 80mg
EXPERIMENTALLurasidone 120mg
EXPERIMENTALSugar Pill
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Provide written informed consent and aged between 18 and 75 years of age.
- Meets DSM-IV™ criteria for a primary diagnosis of schizophrenia.
- Not pregnant, if of reproductive potential agrees to remain abstinent or use adequate and reliable contraception for duration of study.
- Able and agrees to remain off prior antipsychotic medication for the duration of study.
- Good physical health on the basis of medical history, physical examination, and laboratory screening.
- Willing and able to comply with the protocol, including the inpatient requirements and outpatient visits.
You may not qualify if:
- Considered by the investigator to be at imminent risk of suicide or injury to self, others, or property.
- Any chronic organic disease of the CNS (other than schizophrenia)
- Used investigational compound within 30 days.
- Clinically significant or history of alcohol abuse/alcoholism or drug abuse/dependence within the last 6 months.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (48)
K&S Professional Research Services, LLC.
Little Rock, Arkansas, 72201, United States
Comprehensive Neuroscience, Inc
Cerritos, California, 90703, United States
Clinical Innovations, Inc.
Costa Mesa, California, 92647, United States
Collaborative Neuroscience Network Inc.,12772 Valley View Street,Suite 3
Garden Grove, California, 92645, United States
California Clinical Trials
Paramount, California, 90723, United States
Pasadena Research Institute
Pasadena, California, 91107, United States
California Neuropsychopharmacology,CNRI - Los Angeles LLC,8309 Telegraph Road
Pico Rivera, California, 90660, United States
Sharp Mesa Vista Hospital
San Diego, California, 92123, United States
Comprehensive Neuroscience, Inc.
Washington D.C., District of Columbia, 20016, United States
Florida Clinical Research Center, LLC
Bradenton, Florida, 34208, United States
Segal Institute for Clinical Research, Fidelity Clinical Research, Inc.
North Miami, Florida, 33161, United States
Atlanta Center for Medical Research
Atlanta, Georgia, 30308, United States
Alexian Brothers Health System
Hoffman Estates, Illinois, 60169, United States
Lake Charles Clinical Trials LLC
Lake Charles, Louisiana, 70601, United States
Booker, J. Gary, MD. APMC
Shreveport, Louisiana, 71104, United States
Center for Behavioral Health, LLC
Rockville, Maryland, 20850, United States
SUNY Downstate Medical Center
Brooklyn, New York, 11203, United States
Erie County Medical Center, Corp
Buffalo, New York, 14215, United States
CRI Worldwide LLC at Kirkbride
Philadelphia, Pennsylvania, 19139, United States
Research Strategies of Memphis, LLC.
Memphis, Tennessee, 38119, United States
Future Search Trials of Neurology
Austin, Texas, 78756, United States
Hospital Caremeau
Nîmes, 30000, France
S V Medical College
Tirupati, Andh Prad, 517507, India
Government Hospital for Mental Care
Visakhapatnam, Andh Prad, 530017, India
Sheth Vadilal Sarabhai General Hospital
Ahmedabad, Gujarat, 380006, India
Shanti Nursing Home
Aurangabad, Mahara, 431005, India
Madras Medical College & Government General Hospital
Chennai, Tamil Nadu, 600003, India
Deva Mental Health Care
Varanasi, Uttar Prad, 221005, India
Hospital Permai
Johor Bahru, Johor, 81200, Malaysia
University Malaya Medical Centre
Kuala Lumpur, 59100, Malaysia
Spitalul Clinic Judetean de Urgenta Arad
Arad, 310022, Romania
Spitalul de Psihiatrie Titan "Dr. Constantin Gorgos"
Bucharest, 030442, Romania
Spitalul Clinic de Psihiatrie Prof. Dr. Alexandru Obregia
Bucharest, 041914, Romania
Centrul de Recuperare si Reabilitare Gura Ocnitei
Gura Ocniței, 130083, Romania
Spitalul Judetean Arges
Piteşti, 110069, Romania
North State Medical University
Arkhangelsk, 163060, Russia
Republic Psychiatric Hospital
Karelia, 111111, Russia
City Psychoneurological Dispensary #7 (with Hospital)
Saint Petersburg, 190005, Russia
City Psyhiatric Hospital #2 of St. Nikolay Chudotvorets
Saint Petersburg, 190121, Russia
City Psychiatric Hospital #4
Saint Petersburg, 191119, Russia
Bekhterev Psychoneurological Research Institute
Saint Petersburg, 193019, Russia
City Psychiatric Hospital #3 of Skvortsov-Stepanov
Saint Petersburg, 197341, Russia
Dnipropetrovsk Regional Clinical Hospital named Mechnikov
Dnipropetrovsk, 49005, Ukraine
Reg. Clin. Psychiatric Hosp. DSMU n.af.M.Gorkiy
Donetsk, 83037, Ukraine
Kyiv City Clin. Psychoneurolog. Hosp.#1
Kyiv, 04080, Ukraine
Lv. St. Med. Univ. n. af. D. Halytskiy Oblast Clin. Psychon. Hosp
Lviv, 79021, Ukraine
Odesa SMU, based on Odessa Reg. Psychiatric Hosp.#1
Odesa, 65006, Ukraine
Kherson Regional Psychiatric Hospital
Vil. Stepanovka, Kherson, 73488, Ukraine
Related Publications (5)
Nasrallah HA, Silva R, Phillips D, Cucchiaro J, Hsu J, Xu J, Loebel A. Lurasidone for the treatment of acutely psychotic patients with schizophrenia: a 6-week, randomized, placebo-controlled study. J Psychiatr Res. 2013 May;47(5):670-7. doi: 10.1016/j.jpsychires.2013.01.020. Epub 2013 Feb 17.
PMID: 23421963RESULTHopkins SC, Tomioka S, Ogirala A, Loebel A, Koblan KS, Marder SR. Assessment of Negative Symptoms in Clinical Trials of Acute Schizophrenia: Test of a Novel Enrichment Strategy. Schizophr Bull Open. 2022 Apr 7;3(1):sgac027. doi: 10.1093/schizbullopen/sgac027. eCollection 2022 Jan.
PMID: 39144777DERIVEDHopkins SC, Ogirala A, Worden M, Koblan KS. Depicting Safety Profile of TAAR1 Agonist Ulotaront Relative to Reactions Anticipated for a Dopamine D2-Based Pharmacological Class in FAERS. Clin Drug Investig. 2021 Dec;41(12):1067-1073. doi: 10.1007/s40261-021-01094-7. Epub 2021 Nov 9.
PMID: 34751928DERIVEDCorrell CU, Cucchiaro J, Silva R, Hsu J, Pikalov A, Loebel A. Long-term safety and effectiveness of lurasidone in schizophrenia: a 22-month, open-label extension study. CNS Spectr. 2016 Oct;21(5):393-402. doi: 10.1017/S1092852915000917. Epub 2016 Apr 6.
PMID: 27048911DERIVEDNasrallah HA, Cucchiaro JB, Mao Y, Pikalov AA, Loebel AD. Lurasidone for the treatment of depressive symptoms in schizophrenia: analysis of 4 pooled, 6-week, placebo-controlled studies. CNS Spectr. 2015 Apr;20(2):140-7. doi: 10.1017/S1092852914000285. Epub 2014 Jun 23.
PMID: 24955752DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Josephine Cucchiaro
- Organization
- Sunovion Pharmaceuticals Inc.
Study Officials
- STUDY DIRECTOR
Medical Director, MD
Sumitomo Pharma America, Inc.
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
October 24, 2007
First Posted
October 26, 2007
Study Start
October 1, 2007
Primary Completion
October 1, 2010
Study Completion
October 1, 2010
Last Updated
June 11, 2014
Results First Posted
December 14, 2010
Record last verified: 2014-06