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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sunovion
ClinicalTrials.gov Identifier:
NCT00549718
First received: October 24, 2007
Last updated: June 5, 2014
Last verified: June 2014
  Purpose

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 Intervention Phase
Schizophrenia
Drug: Lurasidone HCl
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Sunovion:

Primary Outcome Measures:
  • Change in Total PANSS Score From Baseline to the End of the Double Blind Phase [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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:
  • CGI-S From Baseline to the End of the Double-blind Treatment [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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).


Enrollment: 489
Study Start Date: October 2007
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00549718

  Hide Study Locations
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
France
Hospital Caremeau
Nimes, France, 30000
India
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
Malaysia
Hospital Permai
Johor Bahru, Johor, Malaysia, 81200
University Malaya Medical Centre
Kuala Lumpur, Malaysia, 59100
Romania
Spitalul Clinic Judetean de Urgenta Arad
Arad, Romania, 310022
Spitalul Clinic de Psihiatrie Prof. Dr. Alexandru Obregia
Bucuresti, Romania, 041914
Spitalul de Psihiatrie Titan "Dr. Constantin Gorgos"
Bucuresti, Romania, 030442
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
Bekhterev Psychoneurological Research Institute
St. Petersburg, Russian Federation, 193019
City Psychiatric Hospital #3 of Skvortsov-Stepanov
St. Petersburg, Russian Federation, 197341
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
Ukraine
Dnipropetrovsk Regional Clinical Hospital named Mechnikov
Dnipropetrovsk, Ukraine, 49005
Reg. Clin. Psychiatric Hosp. DSMU n.af.M.Gorkiy
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
Sunovion
Investigators
Study Director: Medical Director, MD Sunovion
  More Information

Publications:
Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT00549718     History of Changes
Other Study ID Numbers: D1050229, 2007-003819-31
Study First Received: October 24, 2007
Results First Received: November 8, 2010
Last Updated: June 5, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Sunovion:
Schizophrenia
SM-13496
Latuda
Lurasidone

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on September 16, 2014