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-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.
- 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)
K&S Professional Research Services, LLC.
🇺🇸Little Rock, Arkansas, 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
California Clinical Trials
🇺🇸Paramount, California, United States
Pasadena Research Institute
🇺🇸Pasadena, California, United States
California Neuropsychopharmacology,CNRI - Los Angeles LLC,8309 Telegraph Road
🇺🇸Pico Rivera, California, United States
Sharp Mesa Vista Hospital
🇺🇸San Diego, California, United States
Comprehensive Neuroscience, Inc.
🇺🇸Washington, District of Columbia, United States
Florida Clinical Research Center, LLC
🇺🇸Bradenton, Florida, United States
Scroll for more (38 remaining)K&S Professional Research Services, LLC.🇺🇸Little Rock, Arkansas, United States