A Clinical Study to learn if SEP-363856 has physical dependence in adults with schizophrenia. This study will be held in approximately 6 study sites in the United States. It will be accepting male and female participants age 18 years to 65 years. Participation will be up to approximately10 weeks.
This is a double-blind, placebo-controlled, randomized withdrawal study comparing abrupt discontinuation of SEP-363856 (SEP-363856 switched to placebo) to continuous SEP-363856 treatment in male and female adult subjects with schizophrenia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
SEP-363856 Tablet
Placebo Tablet
Woodland International Research Group, LLC
Little Rock, Arkansas, United States
Woodland Research Northwest
Rogers, Arkansas, United States
Behavioral Clinical Research, Inc
Miami Lakes, Florida, United States
Research Centers of America at Fort Lauderdale Behavioral Health Center
Oakland Park, Florida, United States
Maximum change from the steady-state baseline (CSSBmax) in the total score of the 20 item Physician Withdrawal Checklist (PWC-20) during the 7-day Randomized Withdrawal Period
Time frame: up to10 weeks
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Atlanta Center for Medical Research
Atlanta, Georgia, United States
Neuro-Behavioral Clinical Research, Inc
North Canton, Ohio, United States
Pillar Clinical Research, LLC
Richardson, Texas, United States