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

Sumitomo Pharma America, Inc.489 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

489

Conditions

Schizophrenia

Interventions

Lurasidone HClDRUG

Once daily

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (48)

Outcomes

Primary Outcomes

Change in Total PANSS Score From Baseline to the End of the Double Blind Phase

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.

Time frame: 6 weeks

Secondary Outcomes

CGI-S From Baseline to the End of the Double-blind Treatment

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).

Time frame: 6 weeks

Data from ClinicalTrials.gov

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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 D.C., District of Columbia, United States

Florida Clinical Research Center, LLC

Bradenton, Florida, United States

...and 38 more locations