Safety and Efficacy of MK-6096 as Adjunctive Therapy in Participants With Major Depressive Disorder And Partial Response to Antidepressant Monotherapy (MK-6096-022)

Summary

The purpose of this study is to evaluate the safety and efficacy of filorexant (MK-6096) versus placebo as adjunctive treatment for major depressive disorder (MDD), in participants who are partial responders to antidepressant monotherapy with one of identified selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs), or bupropion. The primary hypothesis of the study is that filorexant is superior to placebo as augmentation therapy with respect to change from baseline to Week 6 in the Montgomery Asberg Depression Rating Scale (MADRS) total score.

Timeline

Start

2012-05-18

Primary completion

2013-09-03

Completion

2013-09-03

Outcome

Missed primary endpoint

Stopped (Enrollment): “Low Enrollment”

paper There was no statistically significant difference in the primary endpoint of change from baseline to week 6 in Montgomery Asberg Depression Rating Scale total score; PMID 28582570 ↗

registry analysis (superiority or other test); Filorexant 10 mg (Treatment Phase) vs Placebo (Treatment Phase); p = 0.679; Difference in least squares means -0.7 (95% CI -3.8 to 2.5); NCT01554176 ↗

Publications

• Results Connor KM, Ceesay P, Hutzelmann J, Snavely D, Krystal AD, Trivedi MH, Thase M, Lines C, Herring WJ, Michelson D. Phase II Proof-of-Concept Trial of the Orexin Receptor Antagonist Filorexant (MK-6096) in Patients with Major Depressive Disorder. Int J Neuropsychopharmacol. 2017 Aug 1;20(8):613-618. doi: 10.1093/ijnp/pyx033.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Filorexant	Small molecule	10 mg	Oral

Indications