Clinical trial NCT00549718: Lurasidone HCl: A Phase 3 Study of Patients With Acute Schizophrenia
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Keywords: Schizophrenia
SM-13496
Latuda
Lurasidone
Lead sponsor: Sumitomo Pharma America, Inc.
Sponsor class: INDUSTRY
First posted: 2007-10-26
Enrollment: 489
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

To be eligible to enter the study, each patient must comply with the following inclusion criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in Total PANSS Score From Baseline to the End of the Double Blind Phase
timeFrame: 6 weeks
Secondary outcomes:
measure: CGI-S From Baseline to the End of the Double-blind Treatment
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: K&S Professional Research Services, LLC.
state: Arkansas
city: Cerritos
country: United States
facility: Comprehensive Neuroscience, Inc
state: California
city: Costa Mesa
country: United States
facility: Clinical Innovations, Inc.
state: California
city: Garden Grove
country: United States
facility: Collaborative Neuroscience Network Inc.,12772 Valley View Street,Suite 3
state: California
city: Paramount
country: United States
facility: California Clinical Trials
state: California
city: Pasadena
country: United States
facility: Pasadena Research Institute
state: California
city: Pico Rivera
country: United States
facility: California Neuropsychopharmacology,CNRI - Los Angeles LLC,8309 Telegraph Road
state: California
city: San Diego
country: United States
facility: Sharp Mesa Vista Hospital
state: California
city: Washington
country: United States
facility: Comprehensive Neuroscience, Inc.
state: District of Columbia
city: Bradenton
country: United States
facility: Florida Clinical Research Center, LLC
state: Florida
city: North Miami
country: United States
facility: Segal Institute for Clinical Research, Fidelity Clinical Research, Inc.
state: Florida
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research
state: Georgia
city: Hoffman Estates
country: United States
facility: Alexian Brothers Health System
state: Illinois
city: Lake Charles
country: United States
facility: Lake Charles Clinical Trials LLC
state: Louisiana
city: Shreveport
country: United States
facility: Booker, J. Gary, MD. APMC
state: Louisiana
city: Rockville
country: United States
facility: Center for Behavioral Health, LLC
state: Maryland
city: Brooklyn
country: United States
facility: SUNY Downstate Medical Center
state: New York
city: Buffalo
country: United States
facility: Erie County Medical Center, Corp
state: New York
city: Philadelphia
country: United States
facility: CRI Worldwide LLC at Kirkbride
state: Pennsylvania
city: Memphis
country: United States
facility: Research Strategies of Memphis, LLC.
state: Tennessee
city: Austin
country: United States
facility: Future Search Trials of Neurology
state: Texas
city: Nimes
country: France
facility: Hospital Caremeau
city: Tirupati
country: India
facility: S V Medical College
state: Andh Prad
city: Visakhapatnam
country: India
facility: Government Hospital for Mental Care
state: Andh Prad
city: Ahmedabad
country: India
facility: Sheth Vadilal Sarabhai General Hospital
state: Gujarat
city: Aurangabad
country: India
facility: Shanti Nursing Home
state: Mahara
city: Chennai
country: India
facility: Madras Medical College & Government General Hospital
state: Tamilnadu
city: Varanasi
country: India
facility: Deva Mental Health Care
state: Uttar Prad
city: Johor Bahru
country: Malaysia
facility: Hospital Permai
state: Johor
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre
city: Arad
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Arad
city: Bucuresti
country: Romania
facility: Spitalul de Psihiatrie Titan "Dr. Constantin Gorgos"
city: Bucuresti
country: Romania
facility: Spitalul Clinic de Psihiatrie Prof. Dr. Alexandru Obregia
city: Gura Ocnitei
country: Romania
facility: Centrul de Recuperare si Reabilitare Gura Ocnitei
city: Pitesti
country: Romania
facility: Spitalul Judetean Arges
city: Arkhangelsk
country: Russian Federation
facility: North State Medical University
city: Karelia
country: Russian Federation
facility: Republic Psychiatric Hospital
city: St. Petersburg
country: Russian Federation
facility: City Psychoneurological Dispensary #7 (with Hospital)
city: St. Petersburg
country: Russian Federation
facility: City Psyhiatric Hospital #2 of St. Nikolay Chudotvorets
city: St. Petersburg
country: Russian Federation
facility: City Psychiatric Hospital #4
city: St. Petersburg
country: Russian Federation
facility: Bekhterev Psychoneurological Research Institute
city: St. Petersburg
country: Russian Federation
facility: City Psychiatric Hospital #3 of Skvortsov-Stepanov
city: Dnipropetrovsk
country: Ukraine
facility: Dnipropetrovsk Regional Clinical Hospital named Mechnikov
city: Donetsk
country: Ukraine
facility: Reg. Clin. Psychiatric Hosp. DSMU n.af.M.Gorkiy
city: Kyiv
country: Ukraine
facility: Kyiv City Clin. Psychoneurolog. Hosp.#1
city: Lviv
country: Ukraine
facility: Lv. St. Med. Univ. n. af. D. Halytskiy Oblast Clin. Psychon. Hosp
city: Odessa
country: Ukraine
facility: Odesa SMU, based on Odessa Reg. Psychiatric Hosp.#1
city: vil. Stepanovka, Kherson
country: Ukraine
facility: Kherson Regional Psychiatric Hospital
Study officials:
affiliation: Sumitomo Pharma America, Inc.
name: Medical Director, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Hopkins 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.
citation: Correll 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.
citation: Nasrallah 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.