The purpose of this study is to test a new drug, RG2417, to see how the drug affects symptoms of bipolar I depression and to make sure it is safe in humans.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
180
MADRS Score
Time frame: Baseline and weekly for 8 weeks
CGI-BP-S
Time frame: Baseline and weekly for 8 weeks
Safety Findings (includes AE frequency, YMRS Score and CSSR-S Score)
Time frame: Baseline, 8 weeks of study drug dosing and one follow up visit at 4 weeks
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Birmingham Psychiatry Pharmaceutical Studies, Inc.
Birmingham, Alabama, United States
K&S Professional Research Services
Little Rock, Arkansas, United States
Affiliated Research Institute
San Diego, California, United States
Yale University
New Haven, Connecticut, United States
Behavioral Clinical Research
North Miami, Florida, United States
Clinical Neuroscience Solution, Inc.
Orlando, Florida, United States
University of South Florida College of Medicine
Tampa, Florida, United States
Atlanta Center for Medical Research
Atlanta, Georgia, United States
Carman Research
Smyrna, Georgia, United States
Valle Vista Health System
Greenwood, Indiana, United States
...and 26 more locations