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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02669030
Recruitment Status : Recruiting
First Posted : January 29, 2016
Last Update Posted : February 27, 2019
Sponsor:
Collaborator:
Augusta University, Dept. of Psychiatry
Information provided by (Responsible Party):
Institute for Advanced Medical Research, Alpharetta, GA

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : March 1, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antidepressants
Drug Information available for: Suvorexant

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 Name: Belsomra®

Placebo Comparator: Placebo
no augmentation of FDA-approved antidepressant treatment
Drug: Placebo
control group




Primary Outcome Measures :
  1. Total Sleep Time [ Time Frame: Six weeks ( baseline to end of treatment) ]
    assessment of total amount of time spent sleeping


Secondary Outcome Measures :
  1. Insomnia Severity Index (ISI) [ Time Frame: Six weeks ( baseline to end of treatment) ]
    assessment of insomnia severity

  2. Hamilton Depression Rating Scale [ Time Frame: Six weeks ( baseline to end of treatment) ]
    assessment fo depressive symptom severity

  3. Sheehan Disability Scale [ Time Frame: Six weeks ( baseline to end of treatment) ]
    assessment of impact of symptoms on performance

  4. Wake After Sleep Onset (WASO) [ Time Frame: Six weeks ( baseline to end of treatment) ]
    assessment of amount of time spent awake after initial onset of sleep

  5. Sleep Latency (SL) [ Time Frame: Six weeks ( baseline to end of treatment) ]
    assessment of amount of time it takes to fall asleep

  6. Perceived Deficits Questionnaire (PDQ) [ Time Frame: Six weeks ( baseline to end of treatment) ]
    a brief patient-rated scale to assess subjective cognitive dysfunction in people with depression



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02669030


Contacts
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Contact: Brandon Lenfest, BS 770-817-9200 info@iamresearch.org

Locations
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United States, Georgia
Institute for Advanced Medical Research @ Mercer Univeristy Recruiting
Atlanta, Georgia, United States, 30341
Contact: Anna Kerlin, BS    770-817-9200    info@iamresearch.org   
Principal Investigator: Angelo Sambunaris, MD         
Medical College of GA at Augusta Univeristy Recruiting
Augusta, Georgia, United States, 30912
Principal Investigator: Vaughn McCall, MD         
Sponsors and Collaborators
Institute for Advanced Medical Research, Alpharetta, GA
Augusta University, Dept. of Psychiatry
Investigators
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Principal Investigator: Angelo Sambunaris, MD Institute for Advanced Medical Research
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Responsible Party: Institute for Advanced Medical Research, Alpharetta, GA
ClinicalTrials.gov Identifier: NCT02669030    
Other Study ID Numbers: SVX-IIT2016-001
First Posted: January 29, 2016    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: February 2019

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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
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Suvorexant
Sleep Aids, Pharmaceutical
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Orexin Receptor Antagonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action