At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 431 enrolled
Drug / intervention
FK949E +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase II/III Study of FK949E: Placebo-controlled, Double-blind, Parallel-group Comparative Study and Open-label, Non-controlled Extension Study in Bipolar Disorder Patients With Major Depressive Episodes
In Brief
A Phase 3 clinical trial evaluating FK949E and Placebo for Bipolar Disorder. Completed, enrolled 431 participants across 98 sites.
Detailed Summary
In period I, the treatment effect of FK949E was compared with that of placebo in a blind manner in bipolar disorder patients with major depressive episodes. In period II, the long-term safety and efficacy of FK949E was evaluated.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBipolar Disorder
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartFeb 2012
First PostedNov 2012
Primary CompletionAug 2015
Study CompletionJul 2016
TodayJul 2026
First PostedNov 12, 2012
Enrollment StartFeb 7, 2012
Primary CompletionAug 1, 2015
Study CompletionJul 11, 2016
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 13.6 years ago
Interventions
FK949Edrug
Taken by mouth (orally).
Placebodrug
Taken by mouth (orally).