A phase 3 randomised placebo- and active comparator-controlled, clinical trial to study the safety and efficacy of two doses of lurasidone HCL in acutely psychotic patients with schizophrenia
- Conditions
- SchizophreniaMental and Behavioural Disorders
- Registration Number
- ISRCTN33909010
- Lead Sponsor
- Dainippon Sumitomo Pharma America Inc. (USA)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 480
1. Aged between 18 and 75 years of age, both genders
2. Those who provide written informed consent
3. Meets Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM IV) criteria for a primary diagnosis of schizophrenia
4. Not pregnant; if of reproductive potential agrees to remain abstinent or use adequate and reliable contraception for duration of study
5. Able and agrees to remain off prior antipsychotic medication for the duration of study
6. Good physical health on the basis of medical history, physical examination, and laboratory screening
7. Willing and able to comply with the protocol, including the inpatient requirements and outpatient visits
1. Considered by the investigator to be at imminent risk of suicide or injury to self, others or property
2. Any chronic organic disease of the central nervous system (CNS) (other than schizophrenia)
3. Used investigational compound within 30 days
4. Clinically significant or history of alcohol abuse/alcoholism or drug abuse/dependence within the last 6 months
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in total PANSS (the Positive And Negative Syndrome Scale) score from baseline to the end of the 6-week double-bind treatment period.
- Secondary Outcome Measures
Name Time Method Clinical Global Impressions - Severity (CGI-S) from baseline to the end of the double-blind treatment.