Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2017 Aug 1;20(8):613-618.
doi: 10.1093/ijnp/pyx033.

Phase II Proof-of-Concept Trial of the Orexin Receptor Antagonist Filorexant (MK-6096) in Patients with Major Depressive Disorder

Kathryn M Connor  1 , Paulette Ceesay  1 , Jill Hutzelmann  1 , Duane Snavely  1 , Andrew D Krystal  1 , Madhukar H Trivedi  1 , Michael Thase  1 , Christopher Lines  1 , W Joseph Herring  1 , David Michelson  1
Affiliations
Clinical Trial

Phase II Proof-of-Concept Trial of the Orexin Receptor Antagonist Filorexant (MK-6096) in Patients with Major Depressive Disorder

Kathryn M Connor et al. Int J Neuropsychopharmacol. .

Abstract

Background: We evaluated the orexin receptor antagonist filorexant (MK-6096) for treatment augmentation in patients with major depressive disorder.

Methods: We conducted a 6-week, double-blind, placebo-controlled, parallel-group, Phase II, proof-of-concept study. Patients with major depressive disorder (partial responders to ongoing antidepressant therapy) were randomized 1:1 to once-daily oral filorexant 10 mg or matching placebo.

Results: Due to enrollment challenges, the study was terminated early, resulting in insufficient statistical power to detect a prespecified treatment difference; of 326 patients planned, 129 (40%) were randomized and 128 took treatment. 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; the estimated treatment difference for filorexant-placebo was -0.7 (with negative values favoring filorexant) (P=.679). The most common adverse events were somnolence and suicidal ideation.

Conclusions: The interpretation of the results is limited by the enrollment, which was less than originally planned, but the available data do not suggest efficacy of orexin receptor antagonism with filorexant for the treatment of depression. (Clinical Trial Registry: clinicaltrials.gov: NCT01554176).

Keywords: MK-6096; depression; filorexant; orexin receptor antagonist.

PubMed Disclaimer

Similar articles

See all similar articles

Cited by

See all "Cited by" articles

References

    1. American Psychiatric Association (2000) Diagnostic and statistical manual of mental disorders. 4th ed, text revision. Washington, DC: American Psychiatric Association.
    1. Baglioni C, Riemann D (2012) Is chronic insomnia a precursor to major depression? Epidemiological and biological findings. Curr Psychiatry Rep 14:511–518. - PubMed
    1. Bastien CH, Vallières A, Morin CM (2001) Validation of the insomnia severity index as an outcome measure for insomnia research. Sleep Med 2:297–307. - PubMed
    1. Bent-Hansen J, Bech P (2011) Validity of the definite and semidefinite questionnaire version of the Hamilton Depression Scale, the Hamilton Subscale and the Melancholia Scale. Part I. Eur Arch Psychiatry Clin Neurosci 261:37–46. - PubMed
    1. Berridge CW, Espana RA, Vittoz NM (2010) Hypocretin/orexin in arousal and stress. Brain Res 1314:91–102. - PMC - PubMed

Publication types

Associated data