Lurasidone HCl: A Phase 3 Study of Patients With Acute Schizophrenia
- Registration Number
- NCT00549718
- Lead Sponsor
- Sumitomo Pharma America, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 489
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-IVâ„¢ 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.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lurasidone 40mg Lurasidone HCl - Sugar Pill Lurasidone HCl - Lurasidone 80mg Lurasidone HCl - Lurasidone 120mg Lurasidone HCl -
- Primary Outcome Measures
Name Time Method Change in Total PANSS Score From Baseline to the End of the Double Blind Phase 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
Name Time Method CGI-S From Baseline to the End of the Double-blind Treatment 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).
Trial Locations
- Locations (48)
Clinical Innovations, Inc.
🇺🇸Costa Mesa, California, United States
Collaborative Neuroscience Network Inc.,12772 Valley View Street,Suite 3
🇺🇸Garden Grove, California, United States
Center for Behavioral Health, LLC
🇺🇸Rockville, Maryland, United States
Booker, J. Gary, MD. APMC
🇺🇸Shreveport, Louisiana, United States
CRI Worldwide LLC at Kirkbride
🇺🇸Philadelphia, Pennsylvania, United States
Atlanta Center for Medical Research
🇺🇸Atlanta, Georgia, United States
Odesa SMU, based on Odessa Reg. Psychiatric Hosp.#1
🇺🇦Odessa, Ukraine
Erie County Medical Center, Corp
🇺🇸Buffalo, New York, United States
City Psychiatric Hospital #3 of Skvortsov-Stepanov
🇷🇺St. Petersburg, Russian Federation
K&S Professional Research Services, LLC.
🇺🇸Little Rock, Arkansas, United States
Comprehensive Neuroscience, Inc
🇺🇸Cerritos, California, United States
Pasadena Research Institute
🇺🇸Pasadena, California, United States
California Clinical Trials
🇺🇸Paramount, California, United States
California Neuropsychopharmacology,CNRI - Los Angeles LLC,8309 Telegraph Road
🇺🇸Pico Rivera, California, United States
Segal Institute for Clinical Research, Fidelity Clinical Research, Inc.
🇺🇸North Miami, Florida, United States
Lake Charles Clinical Trials LLC
🇺🇸Lake Charles, Louisiana, United States
SUNY Downstate Medical Center
🇺🇸Brooklyn, New York, United States
Hospital Caremeau
🇫🇷Nimes, France
Hospital Permai
🇲🇾Johor Bahru, Johor, Malaysia
Spitalul Clinic Judetean de Urgenta Arad
🇷🇴Arad, Romania
Spitalul de Psihiatrie Titan "Dr. Constantin Gorgos"
🇷🇴Bucuresti, Romania
Bekhterev Psychoneurological Research Institute
🇷🇺St. Petersburg, Russian Federation
City Psychoneurological Dispensary #7 (with Hospital)
🇷🇺St. Petersburg, Russian Federation
Reg. Clin. Psychiatric Hosp. DSMU n.af.M.Gorkiy
🇺🇦Donetsk, Ukraine
Spitalul Clinic de Psihiatrie Prof. Dr. Alexandru Obregia
🇷🇴Bucuresti, Romania
North State Medical University
🇷🇺Arkhangelsk, Russian Federation
Kyiv City Clin. Psychoneurolog. Hosp.#1
🇺🇦Kyiv, Ukraine
Research Strategies of Memphis, LLC.
🇺🇸Memphis, Tennessee, United States
S V Medical College
🇮🇳Tirupati, Andh Prad, India
University Malaya Medical Centre
🇲🇾Kuala Lumpur, Malaysia
Republic Psychiatric Hospital
🇷🇺Karelia, Russian Federation
Kherson Regional Psychiatric Hospital
🇺🇦vil. Stepanovka, Kherson, Ukraine
Comprehensive Neuroscience, Inc.
🇺🇸Washington, District of Columbia, United States
Government Hospital for Mental Care
🇮🇳Visakhapatnam, Andh Prad, India
Sheth Vadilal Sarabhai General Hospital
🇮🇳Ahmedabad, Gujarat, India
Spitalul Judetean Arges
🇷🇴Pitesti, Romania
City Psyhiatric Hospital #2 of St. Nikolay Chudotvorets
🇷🇺St. Petersburg, Russian Federation
Dnipropetrovsk Regional Clinical Hospital named Mechnikov
🇺🇦Dnipropetrovsk, Ukraine
Shanti Nursing Home
🇮🇳Aurangabad, Mahara, India
Centrul de Recuperare si Reabilitare Gura Ocnitei
🇷🇴Gura Ocnitei, Romania
City Psychiatric Hospital #4
🇷🇺St. Petersburg, Russian Federation
Deva Mental Health Care
🇮🇳Varanasi, Uttar Prad, India
Lv. St. Med. Univ. n. af. D. Halytskiy Oblast Clin. Psychon. Hosp
🇺🇦Lviv, Ukraine
Madras Medical College & Government General Hospital
🇮🇳Chennai, Tamilnadu, India
Alexian Brothers Health System
🇺🇸Hoffman Estates, Illinois, United States
Florida Clinical Research Center, LLC
🇺🇸Bradenton, Florida, United States
Future Search Trials of Neurology
🇺🇸Austin, Texas, United States
Sharp Mesa Vista Hospital
🇺🇸San Diego, California, United States