Trial | NCT02669030  Report issue

Official Title

A Six Week, Randomized, Double-Blind Placebo-Controlled, Suvorexant Augmentation Study of Antidepressant Treatment of Major Depressive Disorder With Residual Insomnia

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    suvorexant ...

  • Study Participants

    74
Depression with ongoing insomnia is a common clinical presentation with patients. Clinical data suggests that patients with insomnia that receive concomitant treatment with a sleep aid experience a more robust antidepressant response along with a quicker response. The purpose of this clinical study is to compare the effectiveness of the FDA-approved insomnia medication suvorexant, also known as Belsomra®, as add-on treatment to an antidepressant to that of placebo plus antidepressant treatment in patients with depression and residual or ongoing insomnia.
Many patients with depression suffer from residual insomnia. This study is a six week, randomized, double-blind, placebo-controlled, trial to study suvorexant augmentation of continuing antidepressant therapy against placebo with continuing antidepressant therapy. Patient volunteers must be on a stable antidepressant treatment and will remain on this treatment for the duration of the study. Patient volunteers that qualify and enroll in the clinical trial will either receive suvorexant 10 mg/day and may have it adjusted to a dose of either 15 mg or 20 mg/day. Treatment is for a total of six weeks in addition to a clinical follow-up visit.
Study Started
Mar 01
2017
Primary Completion
Dec 31
2019
Anticipated
Study Completion
Dec 31
2019
Anticipated
Last Update
Feb 27
2019

Drug suvorexant

an FDA-approved sleep aid

  • Other names: Belsomra®

Drug Placebo

control group

Suvorexant Experimental

suvorexant 10mg/day, 15mg/day or 20mg/day augmentation of FDA-approved antidepressant treatment

Placebo Placebo Comparator

no augmentation of FDA-approved antidepressant treatment

Criteria 

Inclusion Criteria:

Provide written Informed Consent
Diagnosis of depression (MDD)
Currently on antidepressant
Healthy and/or stable medically

Exclusion Criteria:

unwilling to discontinue current use of sedative hypnotics/sleep aids/benzodiazepines or over the counter sleep aids/supplements
currently using other psychotropics other than antidepressants
at risk of self harm or a suicide attempt within the past 12 months
history or presence of psychotic disorders
known hypersensitivity to suvorexant
presence of any other sleep disorder other than residual insomnia of depression
No Results Posted