At a glance
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Study AK1113351, a Fixed Dose Study of 323U66 SR in the Treatment of Major Depressive Disorder (MDD) - a Multi-center, Placebo-controlled, Randomized, Double-blind, Parallel-comparison Study
In Brief
A Phase 3 clinical trial evaluating 323U66 SR 150 mg tablet and 323U66 SR 150 mg placebo tablet for Depressive Disorder, Major. Completed, enrolled 572 participants across 59 sites in 2 countries.
Detailed Summary
This is a multi-center, placebo-controlled, randomized, double-blind, parallel-comparison study to confirm the efficacy of 323U66 Sustained Release (SR) orally administered to patients with MDD (Major Depressive Disorder) at doses level of 150 mg/day and 300 mg/day for 8 weeks based on the decrease in MADRS (Montgomery-Asberg Depression Rating Scale) total score, and to evaluate the safety based on adverse events, clinical laboratory tests and vital signs.
Study Details
Timeline
Interventions
323U66 SR 150 mg tablet is orally administered once in the morning and/or once in the evening during the teatment phase.
323U66 SR 150 mg placebo tablet is orally administered once in the evening and/or once in the morning during the teatment phase.