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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00549718
Recruitment Status : Completed
First Posted : October 26, 2007
Results First Posted : December 14, 2010
Last Update Posted : June 11, 2014
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Lurasidone HCl Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 489 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : October 2007
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Lurasidone 40mg Drug: Lurasidone HCl
Once daily
Experimental: Lurasidone 80mg Drug: Lurasidone HCl
Once daily
Experimental: Lurasidone 120mg Drug: Lurasidone HCl
Once daily
Placebo Comparator: Sugar Pill Drug: Lurasidone HCl
Once daily

Primary Outcome Measures :
  1. Change in Total PANSS Score From Baseline to the End of the Double Blind Phase [ Time Frame: 6 weeks ]
    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.

Secondary Outcome Measures :
  1. CGI-S From Baseline to the End of the Double-blind Treatment [ Time Frame: 6 weeks ]
    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).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00549718

  Hide Study Locations
United States, Arkansas
K&S Professional Research Services, LLC.
Little Rock, Arkansas, United States, 72201
United States, California
Comprehensive Neuroscience, Inc
Cerritos, California, United States, 90703
Clinical Innovations, Inc.
Costa Mesa, California, United States, 92647
Collaborative Neuroscience Network Inc.,12772 Valley View Street,Suite 3
Garden Grove, California, United States, 92645
California Clinical Trials
Paramount, California, United States, 90723
Pasadena Research Institute
Pasadena, California, United States, 91107
California Neuropsychopharmacology,CNRI - Los Angeles LLC,8309 Telegraph Road
Pico Rivera, California, United States, 90660
Sharp Mesa Vista Hospital
San Diego, California, United States, 92123
United States, District of Columbia
Comprehensive Neuroscience, Inc.
Washington, District of Columbia, United States, 20016
United States, Florida
Florida Clinical Research Center, LLC
Bradenton, Florida, United States, 34208
Segal Institute for Clinical Research, Fidelity Clinical Research, Inc.
North Miami, Florida, United States, 33161
United States, Georgia
Atlanta Center for Medical Research
Atlanta, Georgia, United States, 30308
United States, Illinois
Alexian Brothers Health System
Hoffman Estates, Illinois, United States, 60169
United States, Louisiana
Lake Charles Clinical Trials LLC
Lake Charles, Louisiana, United States, 70601
Booker, J. Gary, MD. APMC
Shreveport, Louisiana, United States, 71104
United States, Maryland
Center for Behavioral Health, LLC
Rockville, Maryland, United States, 20850
United States, New York
SUNY Downstate Medical Center
Brooklyn, New York, United States, 11203
Erie County Medical Center, Corp
Buffalo, New York, United States, 14215
United States, Pennsylvania
CRI Worldwide LLC at Kirkbride
Philadelphia, Pennsylvania, United States, 19139
United States, Tennessee
Research Strategies of Memphis, LLC.
Memphis, Tennessee, United States, 38119
United States, Texas
Future Search Trials of Neurology
Austin, Texas, United States, 78756
Hospital Caremeau
Nimes, France, 30000
S V Medical College
Tirupati, Andh Prad, India, 517507
Government Hospital for Mental Care
Visakhapatnam, Andh Prad, India, 530017
Sheth Vadilal Sarabhai General Hospital
Ahmedabad, Gujarat, India, 380006
Shanti Nursing Home
Aurangabad, Mahara, India, 431005
Madras Medical College & Government General Hospital
Chennai, Tamilnadu, India, 600003
Deva Mental Health Care
Varanasi, Uttar Prad, India, 221005
Hospital Permai
Johor Bahru, Johor, Malaysia, 81200
University Malaya Medical Centre
Kuala Lumpur, Malaysia, 59100
Spitalul Clinic Judetean de Urgenta Arad
Arad, Romania, 310022
Spitalul de Psihiatrie Titan "Dr. Constantin Gorgos"
Bucuresti, Romania, 030442
Spitalul Clinic de Psihiatrie Prof. Dr. Alexandru Obregia
Bucuresti, Romania, 041914
Centrul de Recuperare si Reabilitare Gura Ocnitei
Gura Ocnitei, Romania, 130083
Spitalul Judetean Arges
Pitesti, Romania, 110069
Russian Federation
North State Medical University
Arkhangelsk, Russian Federation, 163060
Republic Psychiatric Hospital
Karelia, Russian Federation, 111111
City Psychoneurological Dispensary #7 (with Hospital)
St. Petersburg, Russian Federation, 190005
City Psyhiatric Hospital #2 of St. Nikolay Chudotvorets
St. Petersburg, Russian Federation, 190121
City Psychiatric Hospital #4
St. Petersburg, Russian Federation, 191119
Bekhterev Psychoneurological Research Institute
St. Petersburg, Russian Federation, 193019
City Psychiatric Hospital #3 of Skvortsov-Stepanov
St. Petersburg, Russian Federation, 197341
Dnipropetrovsk Regional Clinical Hospital named Mechnikov
Dnipropetrovsk, Ukraine, 49005
Reg. Clin. Psychiatric Hosp. DSMU
Donetsk, Ukraine, 83037
Kyiv City Clin. Psychoneurolog. Hosp.#1
Kyiv, Ukraine, 04080
Lv. St. Med. Univ. n. af. D. Halytskiy Oblast Clin. Psychon. Hosp
Lviv, Ukraine, 79021
Odesa SMU, based on Odessa Reg. Psychiatric Hosp.#1
Odessa, Ukraine, 65006
Kherson Regional Psychiatric Hospital
vil. Stepanovka, Kherson, Ukraine, 73488
Sponsors and Collaborators
Study Director: Medical Director, MD Sunovion

Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Sunovion Identifier: NCT00549718     History of Changes
Other Study ID Numbers: D1050229
2007-003819-31 ( EudraCT Number )
First Posted: October 26, 2007    Key Record Dates
Results First Posted: December 14, 2010
Last Update Posted: June 11, 2014
Last Verified: June 2014

Keywords provided by Sunovion:

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Lurasidone Hydrochloride
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Adrenergic alpha-2 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Serotonin Agents
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Dopamine Agents