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

Sponsor

Institute for Advanced Medical Research, Alpharetta, GA (Other)

Overall Status

Unknown status

CT.gov ID

NCT02669030

Collaborator

Augusta University, Dept. of Psychiatry (Other)

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Depression Major Depressive Disorder MDD Insomnia	Drug: suvorexant Drug: Placebo	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

74 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 1, 2017

Anticipated Primary Completion Date :

Dec 1, 2019

Anticipated Study Completion Date :

Dec 1, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Total Sleep Time [Six weeks ( baseline to end of treatment)]
assessment of total amount of time spent sleeping

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institute for Advanced Medical Research @ Mercer Univeristy	Atlanta	Georgia	United States	30341
2	Medical College of GA at Augusta Univeristy	Augusta	Georgia	United States	30912

Sponsors and Collaborators

Institute for Advanced Medical Research, Alpharetta, GA
Augusta University, Dept. of Psychiatry

Investigators

Principal Investigator: Angelo Sambunaris, MD, Institute for Advanced Medical Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Institute for Advanced Medical Research, Alpharetta, GA

ClinicalTrials.gov Identifier:

NCT02669030

Other Study ID Numbers:

SVX-IIT2016-001

First Posted:

Jan 29, 2016

Last Update Posted:

Feb 27, 2019

Last Verified:

Feb 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Sleep Initiation and Maintenance Disorders

Depression

Depressive Disorder

Depressive Disorder, Major

Suvorexant

Study Results

No Results Posted as of Feb 27, 2019