At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 22 enrolled
Drug / intervention
FK949Edrug
Likely dose
FK949E 50 mgfrom 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.
Study of FK949E - An Open-label, Two-way Crossover Study to Evaluate the Effects of Switching Different Strength Forms of FK949E in Bipolar Disorder Patients With Major Depressive Episodes
In Brief
A Phase 3 clinical trial evaluating FK949E for Bipolar Depression. Completed, enrolled 22 participants across 7 sites.
Detailed Summary
The purpose of this study was to evaluate the efficacy, safety, and pharmacokinetics of switching FK949E (sustained-release quetiapine) 50-mg and 150-mg tablets to the other tablet at the equivalent total daily dose in bipolar disorder patients with major depressive episodes.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBipolar Depression
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedFeb 2015
Enrollment StartFeb 2015
Primary CompletionFeb 2016
TodayJul 2026
First PostedFeb 12, 2015
Enrollment StartFeb 18, 2015
Primary CompletionFeb 6, 2016
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 11.4 years ago
Interventions
FK949Edrug
A tablet containing 50 mg or 150 mg of quetiapine taken orally.