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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

Primary Purpose

Depression, Major Depressive Disorder, MDD

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
suvorexant
Placebo
Sponsored by
Institute for Advanced Medical Research, Alpharetta, GA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Institute for Advanced Medical Research @ Mercer UniveristyRecruiting
  • Medical College of GA at Augusta UniveristyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Suvorexant

Placebo

Arm Description

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

no augmentation of FDA-approved antidepressant treatment

Outcomes

Primary Outcome Measures

Total Sleep Time
assessment of total amount of time spent sleeping

Secondary Outcome Measures

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

Full Information

First Posted
January 27, 2016
Last Updated
February 25, 2019
Sponsor
Institute for Advanced Medical Research, Alpharetta, GA
Collaborators
Augusta University, Dept. of Psychiatry
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1. Study Identification

Unique Protocol Identification Number
NCT02669030
Brief Title
A Six Week, Randomized, Double-Blind Placebo-Controlled, Suvorexant Augmentation Study of Antidepressant Treatment of Major Depressive Disorder With Residual Insomnia
Official Title
A Six Week, Randomized, Double-Blind Placebo-Controlled, Suvorexant Augmentation Study of Antidepressant Treatment of Major Depressive Disorder With Residual Insomnia
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute for Advanced Medical Research, Alpharetta, GA
Collaborators
Augusta University, Dept. of Psychiatry

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Major Depressive Disorder, MDD, Insomnia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
74 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Suvorexant
Arm Type
Experimental
Arm Description
suvorexant 10mg/day, 15mg/day or 20mg/day augmentation of FDA-approved antidepressant treatment
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
no augmentation of FDA-approved antidepressant treatment
Intervention Type
Drug
Intervention Name(s)
suvorexant
Other Intervention Name(s)
Belsomra®
Intervention Description
an FDA-approved sleep aid
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
control group
Primary Outcome Measure Information:
Title
Total Sleep Time
Description
assessment of total amount of time spent sleeping
Time Frame
Six weeks ( baseline to end of treatment)
Secondary Outcome Measure Information:
Title
Insomnia Severity Index (ISI)
Description
assessment of insomnia severity
Time Frame
Six weeks ( baseline to end of treatment)
Title
Hamilton Depression Rating Scale
Description
assessment fo depressive symptom severity
Time Frame
Six weeks ( baseline to end of treatment)
Title
Sheehan Disability Scale
Description
assessment of impact of symptoms on performance
Time Frame
Six weeks ( baseline to end of treatment)
Title
Wake After Sleep Onset (WASO)
Description
assessment of amount of time spent awake after initial onset of sleep
Time Frame
Six weeks ( baseline to end of treatment)
Title
Sleep Latency (SL)
Description
assessment of amount of time it takes to fall asleep
Time Frame
Six weeks ( baseline to end of treatment)
Title
Perceived Deficits Questionnaire (PDQ)
Description
a brief patient-rated scale to assess subjective cognitive dysfunction in people with depression
Time Frame
Six weeks ( baseline to end of treatment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brandon Lenfest, BS
Phone
770-817-9200
Email
info@iamresearch.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angelo Sambunaris, MD
Organizational Affiliation
Institute for Advanced Medical Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute for Advanced Medical Research @ Mercer Univeristy
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30341
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Kerlin, BS
Phone
770-817-9200
Email
info@iamresearch.org
First Name & Middle Initial & Last Name & Degree
Angelo Sambunaris, MD
Facility Name
Medical College of GA at Augusta Univeristy
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vaughn McCall, MD

12. IPD Sharing Statement

Learn more about this trial

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

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