Lurasidone HCl - A Long Term Phase 3 Study of Patients With Chronic Schizophrenia

Phase 3

Completed

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 effective, tolerable, and safe as compared with quetiapine XR long term among schizophrenic outpatients with chronic schizophrenia.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Any chronic organic disease of the CNS (other than schizophrenia).
Considered by the investigator to be at imminent risk of suicide or injury to self, others, or property.

Arm && Interventions

Group	Intervention	Description
Quetiapine	Quetiapine XR	-
Lurasidone HC1	Lurasidone HC1	-

Primary Outcome Measures

Name	Time	Method
Relapse of Psychotic Symptoms	12 Months	Time to relapse will be defined as the earliest occurrence of any of the following: * Worsening of \>= 30% positive and negative syndrome scale total score from NCT00790192 and clinical global impression-severity sub-scale \>=3 * rehospitalization for worsening of psychosis * emergence of suicidal ideation, homicidal ideation and/or risk of harm to self or others Comparison of time to relapse of psychotic symptoms between lurasidone and quetiapine XR after 1 year as analyzed using the Cox proportional hazard model with country as a covariate.

Secondary Outcome Measures

Name	Time	Method
Change From the Acute Phase Baseline to Month 6 of the Double-blind Treatment in the CogState Computerized Cognitive Scores.	Baseline and 6 Months	The battery has seven outcome measures that measure the cognitive constructs. The seven domains are: detection, identification, one back task, international shopping list task, one card learning task, Groton maze learning task and social emotional matching. The standardized scores for each subject at each assessment will then be averaged to yield a composite score. There are no maximum or minimum values, however a higher score indicates improved performance on the cognitive constructs. The change score is change from baseline to month 6.
Change From the Acute Phase Baseline to the End (Month 12) of the Double-blind Treatment in the Clinical Global Impression Severity Scale (CGI-S) Scores	Baseline and 12 months	The CGI-S is a clinician-rated assessment of the subject's current illness state on a scale ranging from 1-7, where a higher score is associated with greater illness severity.
Change From the Acute Phase Baseline to the End (Month 12) of the Double-blind Treatment in the Positive and Negative Syndrome Scale (PANSS)	Baseline and 12 months	The PANSS is an interview-based measure of psychopathology severity in adults with psychotic disorders. Thirty items are rated using a Likert scale, from 1 - 7. The PANSS total score is the sum of thirty items ranging from 30 to 210 (higher score representing a worsening in psychosis).

Locations (62): K&S Professional Research Services, LLC
🇺🇸
Little Rock, Arkansas, United States
Woodland International Research Group
🇺🇸
Little Rock, Arkansas, United States
Comprehensive Neuroscience, Inc
🇺🇸
Holliswood, New York, United States
Clinical Innovations, Inc.
🇺🇸
Riverside, California, United States
Synergy Escondido,710 East Grand Ave.
🇺🇸
Escondido, California, United States
Collaborative Neuroscience Network Inc
🇺🇸
Garden Grove, California, United States
Apostle Clinical Trials, Inc.
🇺🇸
Long Beach, California, United States
California Clinical Trials
🇺🇸
Paramount, California, United States
Pasadena Research Institute
🇺🇸
Pasadena, California, United States
CNRI - Los Angeles LLC,8309 Telegraph Road
🇺🇸
Pico Rivera, California, United States
Scroll for more (52 remaining)
K&S Professional Research Services, LLC
🇺🇸Little Rock, Arkansas, United States