At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 200 enrolled
Drug / intervention
Fluoxetinedrug
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.
A Phase 3, Open-label, Long-Term Study to Evaluate the Safety of LY110140 Once Daily Dosing for 52-week in Japanese Patients With Major Depressive Disorder
In Brief
A Phase 3 clinical trial evaluating Fluoxetine for Major Depressive Disorder. Completed, enrolled 200 participants across 16 sites.
Detailed Summary
This study will evaluate the safety and effectiveness of fluoxetine flexible dosing in the treatment of MDD in adult Japanese participants. Participants who complete the short-term treatment phase of Study B1Y-JE-HCLV (NCT#: NCT01808612) will be allowed to enroll in this study, and receive fluoxetine treatment for an additional 52 weeks.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMajor Depressive Disorder
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMar 2013
Enrollment StartMay 2013
Primary CompletionMar 2015
TodayJul 2026
First PostedMar 11, 2013
Enrollment StartMay 1, 2013
Primary CompletionMar 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 13.3 years ago
Interventions
Fluoxetinedrug
Administered orally