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

Institute for Advanced Medical Research, Alpharetta, GA

Status and phase: Unknown; Phase 4

Conditions: Major Depressive Disorder; Insomnia; Depression; MDD

Treatments: Drug: Placebo; Drug: suvorexant

Study type: Interventional

Funder types: Other

Identifiers

NCT02669030

SVX-IIT2016-001

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 74 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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74 participants in 2 patient groups, including a placebo group

Suvorexant

Experimental group

Description:

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

Treatment:

Drug: suvorexant

Placebo

Placebo Comparator group

Description:

no augmentation of FDA-approved antidepressant treatment

Treatment:

Drug: Placebo