The purpose of this study is to evaluate the effect of AMG 747 on negative symptoms of schizophrenia in patients who are stable on current antipsychotic treatment. After a run-in period on their current antipsychotic treatment, patients will be randomized to one of the four treatment arms as add-on therapy for a treatment duration of up to 3 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
121
Change from baseline to week 12 in negative symptoms, as measured by the NSA-16 total score
NSA-16 = 16-item Negative Symptom Assessment Scale, an efficacy scale used for the primary endpoint
Time frame: 12 Weeks
Response defined as a ≥ 20% decrease in the NSA-16 total score at week 12
NSA-16 = 16-item Negative Symptom Assessment Scale
Time frame: 12 weeks
Change from baseline to week 12 on the PANSS total score and Marder factor scores
Positive and Negative Syndrome Scale (PANSS)
Time frame: 12 weeks
Change from baseline to week 12 on the CGI-S
Clinical Global Impression Severity Scale (CGI-S)
Time frame: Week 12
CGI-I scores at week 12
Clinical Global Impression Improvement (CGI-I)
Time frame: 12 weeks
Change on cognition battery
Time frame: 12 weeks
Change in personal and social functioning
Time frame: 12 weeks
Change on patient reported outcomes
Time frame: 12 weeks
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Anaheim, California, United States
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Cerritos, California, United States
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Culver City, California, United States
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Los Angeles, California, United States
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Norwalk, California, United States
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San Bernardino, California, United States
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Torrance, California, United States
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Washington D.C., District of Columbia, United States
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North Miami, Florida, United States
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