Lurasidone HCL - A 6-week Phase 3 Study of Patients With Acute Schizophrenia.

Schizophrenia Clinical Trial

— PEARL 3  

Official title:

A Phase 3 Randomized, Double-Blind, Placebo- and Active Comparator-Controlled Clinical Trial to Study the Efficacy and Safety of Two Doses of Lurasidone in Acutely Psychotic Subjects With Schizophrenia (PEARL 3)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00790192
• Other study ID #: D1050233
• Status: Completed
• Phase: Phase 3
• First received: November 10, 2008
• Last updated: March 11, 2016
• Start date: October 2008
• Est. completion date: July 2010

Study information

• Verified date: March 2016
• 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 effective, tolerable, and safe as compared with quetiapine XR short term among acutely psychotic patients with chronic schizophrenia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 488
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Lurasidone
Lurasidone 80 mg tablets
• Lurasidone
Lurasidone 4 40 mg tablets
• Quetiapine XR
Quetiapine XR 600mg
• Placebo
Matching Placebo to Lurasidone or Quetiapine

Locations

Country	Name	City	State
India	Seth K M School of P G Medicine & Research	Ahmedabad	Gujarat
India	Shanti Nursing Home	Aurangabad	Maharastra
India	Madras Medical College & Government General Hospital	Chennai	TamilNadu
India	Justice K.S. Hegde Charitable Hospital	Mangalore	Karnataka
India	JSS Medical College and Hospital	Mysore	Karnataka
India	Deenanath Mangeshkar Hospital and Research Centre	Pune	Maharastra
India	Mahatma Gandhi Institute of Medical Sciences	Sewagram	Maharastra
India	S.V. Medical College	Tirupati	Andra Pradesh
India	SBKS Medical Institute and Research Centre	Vadodara	Gujarat
India	Vijayawada Institute of Mental Health and Neurosciences	Vijayawada	Andhra Pradesh
Romania	Spitalul de Psihiatrie Titan "Dr. Constantin Gorgos"	Bdul Nicolae Grigorescu nr. 41	Bucuresti
Romania	Spitalul Clinic de Psihiatrie Prof. Dr. Alexandru Obregia	Bucuresti
Romania	Spitalul Clinic de Neurologie si Psihiatrie Oradea	Oradea
Romania	Spitalul Clinic de Psihiatrie Prof. Dr. Alexandru Obregia	Sos. Berceni nr. 10-12	Bucuresti
Romania	Spitalul Judetean Arges	Str. Negru Voda nr. 53	Pitesti
Romania	Spitalul Clinic Judetean de Urgenta Arad	Str. Octavian Goga nr. 17	Arad
Russian Federation	SEI of H.P. Educat. Northern SMU	Arkhangelsk
Russian Federation	St. Petersburg SHI Psychiatrical Hosptial #1 n.a. Kaschenko	Gatchina
Russian Federation	Institution of RAMS Mental Health Research Center of RAMS	Moscow
Russian Federation	Moscow Scientific Research Institute of Psychiatry	Moscow
Russian Federation	City Clinical Psichiatric Hospital #1	Nizhniy Novgorod
Russian Federation	SHI Samara Psychiatric Hospital	Samara
Russian Federation	City Psychiatric Hospital #2 of St. Nikolay Chudotvorets	St. Petersburg
Russian Federation	City Psychiatric Hospital #3 of Skvortsov-Stepanov	St. Petersburg
Russian Federation	City Psychiatric Hospital #4	St. Petersburg
Russian Federation	SHI City Psychoneurological Dispensary #7	St. Petersburg
Russian Federation	St. Petersburg GUZ City Psychiatric Hospital #6	St. Petersburg
Ukraine	RCH n.a.I.I.Mechnikov, Reg.Cent. of Psychosom. Pathology	Dnipropetrovsk
Ukraine	Chair of Psychiatry and Medical Psychology	Donetsk
Ukraine	Kherson Regional Psychiatric Hospital	Kherson,vil.	Stepanovka
Ukraine	Centre of Novel Treatment and Rehabilitation of Psychotic disorders	Kyiv
Ukraine	Kyiv City Psychoneurological Hospital	Kyviv
Ukraine	Lviv Reg.St.Cl.Psych.Hosp	Lviv
Ukraine	Reg. Psychiatric Hospital	Odessa
Ukraine	Poltava Regional Clinical Psychiatric Hospital,	Poltava
Ukraine	Crimean republican Clinical Psychiatric Hospital	Simferopol
United States	Community Clinical Research	Austin	Texas
United States	Future Search Trials of Neurology	Austin	Texas
United States	Florida Clinical Research Center	Bradenton	Florida
United States	Clinical Pharmacological Studies, Inc.	Cerritos	California
United States	Comprehensive Neuroscience, Inc	Cerritos	California
United States	Clinical Innovations, Inc.	Costa Mesa	California
United States	Pillar Clinical Research	Dallas	Texas
United States	Synergy Escondido	Escondido	California
United States	Precise Clinical Research	Flowood	Mississippi
United States	Florida Clinical Research Center, LLC	Fruitland Park	Florida
United States	Collaborative Neuroscience Network	Garden Grove	California
United States	Segal Institute for Clinical Research	Highlands Ranch	Colorado
United States	Comprehensive Neuroscience, Inc	Holliswood	New York
United States	Lake Charles Clinical Trials	Lake Charles	Louisiana
United States	K&S Professional Research Services, LLC	Little Rock	Arkansas
United States	Woodland International Research Group	Little Rock	Arkansas
United States	Apostle Clinical Trials, Inc.	Long Beach	California
United States	California Clinical Trials	Paramount	California
United States	Pasadena Research Institute	Pasadena	California
United States	CNRI-Los Angeles. LLC	Pico Rivera	California
United States	Clinical Innovations, Inc.	Riverside	California
United States	CNRI-San Diego	San Diego	California
United States	UCSD Medical Center	Sandeigo	California
United States	Booker, J. Gary, MD. APMC	Shreveport	Louisiana
United States	St. Charles Psychiatric Associates	St Charles	Missouri
United States	St. Louis Research, Inc.	St. Louis	Missouri
United States	Comprehensive Neuroscience, Inc.	Washington	District of Columbia
United States	CRI Worldwide	Willingboro	New Jersey
United States	Segal Institute for Clinical Research	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Sunovion

Countries where clinical trial is conducted

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

References & Publications (3)

Harvey PD, Siu CO, Hsu J, Cucchiaro J, Maruff P, Loebel A. Effect of lurasidone on neurocognitive performance in patients with schizophrenia: a short-term placebo- and active-controlled study followed by a 6-month double-blind extension. Eur Neuropsychoph — View Citation

Loebel A, Cucchiaro J, Sarma K, Xu L, Hsu C, Kalali AH, Pikalov A, Potkin SG. Efficacy and safety of lurasidone 80 mg/day and 160 mg/day in the treatment of schizophrenia: a randomized, double-blind, placebo- and active-controlled trial. Schizophr Res. 20 — View Citation

Loebel AD, Siu CO, Cucchiaro JB, Pikalov AA, Harvey PD. Daytime sleepiness associated with lurasidone and quetiapine XR: results from a randomized double-blind, placebo-controlled trial in patients with schizophrenia. CNS Spectr. 2014 Apr;19(2):197-205. d — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Efficacy Endpoint: Mean Change in Total PANSS Score From Baseline to the End of the Double Blind Phase	The PANSS (Positive and Negative Syndrome Scale) 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.	Week 6	No
Secondary	Secondary Outcome: 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