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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Depression, Major Depressive Disorder, MDD, Insomnia

Intervention / Treatment
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* Drug: suvorexant
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Suvorexant<br>suvorexant 10mg/day, 15mg/day or 20mg/day augmentation of FDA-approved antidepressant treatment | Drug: suvorexant<br>* an FDA-approved sleep aid<br>* Other names: Belsomra®;|
| Placebo Comparator: Placebo<br>no augmentation of FDA-approved antidepressant treatment | Drug: Placebo<br>* control group<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Sleep Time | assessment of total amount of time spent sleeping | Six weeks ( baseline to end of treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insomnia Severity Index (ISI) | assessment of insomnia severity | Six weeks ( baseline to end of treatment) | 
| Hamilton Depression Rating Scale | assessment fo depressive symptom severity | Six weeks ( baseline to end of treatment) | 
| Sheehan Disability Scale | assessment of impact of symptoms on performance | Six weeks ( baseline to end of treatment) | 
| Wake After Sleep Onset (WASO) | assessment of amount of time spent awake after initial onset of sleep | Six weeks ( baseline to end of treatment) | 
| Sleep Latency (SL) | assessment of amount of time it takes to fall asleep | Six weeks ( baseline to end of treatment) | 
| Perceived Deficits Questionnaire (PDQ) | a brief patient-rated scale to assess subjective cognitive dysfunction in people with depression | Six weeks ( baseline to end of treatment) |