The goal of this study is to evaluate the safety and tolerability of elpipodect in participants with stable bipolar I disorder. There was no hypothesis testing in this study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
34
Oral Tablet
Oral Tablet
Woodland International Research Group-Clinical Research ( Site 0009)
Little Rock, Arkansas, United States
Atlanta Center for Medical Research ( Site 0001)
Atlanta, Georgia, United States
Hassman Research Institute Marlton Site ( Site 0006)
Marlton, New Jersey, United States
Number of Participants Who Experience One or More Adverse Events (AEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Time frame: Up to 28 days
Number of Participants Who Discontinue Study Treatment Due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Time frame: Up to 14 days
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