This study is being conducted to further investigate the safety of prolonged exposure to EVP-6124 in subjects with Schizophrenia receiving a stable dose of an atypical antipsychotic who completed double-blind treatment on studies EVP-6124-015 and EVP-6124-016.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
830
Arm 1, 2
Safety and Tolerability of EVP-6124 or Placebo in Subjects with Schizophrenia
All adverse experiences spontaneously reported by subject and/or observed by investigator and repeated clinical evaluation of physical examinations, vital signs, 12-lead ECG (electrocardiogram), ambulatory ECG, and laboratory tests (hematology/blood/chemistry/urinalysis)
Time frame: Baseline through Day 182 or Early Termination
Change from Baseline in the Clinical Global Impression (CGI) - Severity (CGI-S) to Day 182
Time frame: Baseline to Day 182 or Early Termination
Change from Baseline in the Clinical Global Impression (CGI) - Change (CGI-C) to Day 182
Time frame: Baseline to Day 182 or Early Termination
Change from Baseline in the EuroQol-5D (EQ-5D-5L) to Day 182
Time frame: Baseline to Day 182 or Early Termination
Change from Baseline in the Columbia Suicide Severity Rating Scale (C-SSRS) to Day 182
Time frame: Baseline to Day 182 or Early Termination
Change from Baseline in the Client Socio-Demographic and Service Receipt Inventory-European Version (CSSRI-EU) to Day 182
Time frame: Baseline to Day 182 or Early Termination
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Little Rock, Arkansas, United States
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Anaheim, California, United States
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Bellflower, California, United States
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Cerritos, California, United States
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Chino, California, United States
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Costa Mesa, California, United States
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Culver City, California, United States
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Downey, California, United States
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Escondido, California, United States
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Garden Grove, California, United States
...and 118 more locations