At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 172 enrolled
Drug / intervention
quetiapine extended release (XR) +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 2 Study of FK949E - Double-blind, Placebo-controlled, Comparative Study in Major Depressive Disorder Patients With Inadequate Response to Existing Antidepressants
In Brief
A Phase 2 clinical trial evaluating quetiapine extended release (XR) and Placebo for Major Depressive Disorder. Completed, enrolled 172 participants across 3 sites.
Detailed Summary
In this study, quetiapine XR or placebo will be administered orally for 6 weeks to major depressive disorder patients with lack of response to existing antidepressants, with the aim of evaluating the efficacy of quetiapine XR and dose-response in three quetiapine XR dose groups based on changes in Montgomery-Asberg Depression Rating Scale (MADRS) scores.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMajor Depressive Disorder
CountriesJapan
Collaborators--
Timeline
Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartDec 2011
First PostedNov 2012
Primary CompletionAug 2013
TodayJul 2026
First PostedNov 12, 2012
Enrollment StartDec 14, 2011
Primary CompletionAug 24, 2013
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 13.6 years ago
Interventions
quetiapine extended release (XR)drug
Extended release tablets
Placebodrug
matching tablets