Lurasidone HCl: A Phase 3 Study of Patients With Acute Schizophrenia

Schizophrenia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00549718
• Other study ID #: D1050229
• Secondary ID: 2007-003819-31
• Status: Completed
• Phase: Phase 3
• First received: October 24, 2007
• Last updated: June 5, 2014
• Start date: October 2007
• Est. completion date: October 2010

Study information

• Verified date: June 2014
• Source: Sunovion
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 489
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Lurasidone HCl
Once daily

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Sunovion

Countries where clinical trial is conducted

United States,  France,  India,  Malaysia,  Romania,  Russian Federation,  Ukraine, 

References & Publications (1)

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.jps — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	CGI-S From Baseline to the End of the Double-blind Treatment	Clinical Global Impression of Severity 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. The scale has a single item measured on a 7 point scale from 1 ('normal', not ill) to 7 (extremely ill).	6 weeks	No