At a glance
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A Randomized, Double-Blind, Parallel-Group, Placebo Controlled Study to Evaluate the Efficacy and Safety of 2 Fixed Doses (5.0 mg or 2.5 mg) of MIN-117 in Adult Patients With Major Depressive Disorder
In Brief
A Phase 2 clinical trial evaluating MIN-117 5.0 mg, MIN-117 2.5 mg, and 1 other intervention for Major Depressive Disorder. Completed, enrolled 360 participants across 47 sites in 7 countries.
Detailed Summary
MIN-117C03 is a 6-week, 3-arm, randomized, double-blind, placebo controlled study to investigate the safety and efficacy of MIN-117 in male and female patients with Major Depressive Disorder, aged 18 to 65 years. Approximately 324 patients were to be randomly assigned to 1 of 3 treatment arms, including placebo, 2.5 mg MIN-117, or 5.0 mg MIN-117, in a 2:1:1 ratio.
Study Details
Timeline
Interventions
5.0 mg MIN-117 administered as two MIN-117 2.5 mg capsules as a single dose once daily
2.5 mg MIN-117 administered as one MIN-117 2.5 mg capsule and one Placebo capsule as a single dose once daily
Placebo administered as two Placebo capsules as a single dose once daily