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

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.

Study Overview

• Status: Unknown
• Conditions: Depression; Insomnia; Major Depressive Disorder; MDD
• Intervention / Treatment: Drug: Placebo; Drug: suvorexant

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 74
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30341
      • Recruiting
      • Institute for Advanced Medical Research @ Mercer Univeristy
      • Contact: Anna Kerlin, BS; Phone Number: 770-817-9200; Email: info@iamresearch.org
      • Principal Investigator: Angelo Sambunaris, MD
    • Augusta, Georgia, United States, 30912
      • Recruiting
      • Medical College of GA at Augusta Univeristy
      • Principal Investigator: Vaughn McCall, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Institute for Advanced Medical Research, Alpharetta, GA
• Collaborators: Augusta University, Dept. of Psychiatry
• Investigators: Principal Investigator: Angelo Sambunaris, MD, Institute for Advanced Medical Research

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: January 27, 2016
• First Submitted That Met QC Criteria: January 28, 2016
• First Posted (Estimate): January 29, 2016

Study Record Updates

• Last Update Posted (Actual): February 27, 2019
• Last Update Submitted That Met QC Criteria: February 25, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Nervous System Diseases; Mood Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Depression; Depressive Disorder; Sleep Initiation and Maintenance Disorders; Depressive Disorder, Major; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Hypnotics and Sedatives; Sleep Aids, Pharmaceutical; Orexin Receptor Antagonists; Suvorexant
• Other Study ID Numbers: SVX-IIT2016-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No