Participant Flow Module
The Participant Flow Module provides information about the flow of participants through each stage of the clinical trial. This includes pre-assignment details, recruitment information, and the types of units analyzed, helping researchers understand how participants move through the study.
Participant Flow Module path is as follows:
Study -> Results Section -> Participant Flow Module
Participant Flow Module
Ignite Creation Date:
2025-12-26 @ 11:11 PM
Ignite Modification Date:
2025-12-26 @ 11:11 PM
NCT ID:
NCT02362412
Pre Assignment Details:
After informed consent was obtained and prior to randomization in Treatment Period II, participants entered Treatment Period I (4 weeks) to allow a dose titration and reduction for adjusting the dosage regimen of FK949E. Two participants did not enter Treatment Period II (due to an adverse event and withdrawal of consent, respectively).
Recruitment Details:
Participants with documented clinical diagnosis meeting the DSM-IV-TR criteria for bipolar I disorder or bipolar II disorder, with most recent episode depressed (296.50 to 296.54 or 296.89) confirmed by the Mini-International Neuropsychiatric Interview (M.I.N.I.) were recruited from 10 sites in Japan.
Study:
NCT02362412
Study Brief:
Results Section:
NCT02362412