← Back to Search

Suvorexant for Insomnia

Phase 4
Waitlist Available
Led By Angelo Sambunaris, MD
Research Sponsored by Institute for Advanced Medical Research, Alpharetta, GA
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Healthy and/or stable medically
Provide written Informed Consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up six weeks ( baseline to end of treatment)
Awards & highlights

Study 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.

Eligible Conditions
  • Depression
  • Insomnia

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~six weeks ( baseline to end of treatment)
This trial's timeline: 3 weeks for screening, Varies for treatment, and six weeks ( baseline to end of treatment) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Total Sleep Time
Secondary outcome measures
Hamilton Depression Rating Scale
Insomnia Severity Index (ISI)
Perceived Deficits Questionnaire (PDQ)
+3 more

Side effects data

From 2020 Phase 4 trial • 60 Patients • NCT03034018
15%
somnolence
11%
dry mouth
7%
mood symptoms
7%
gastro-intestinal symptoms
4%
headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Suvorexant
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: SuvorexantExperimental Treatment1 Intervention
suvorexant 10mg/day, 15mg/day or 20mg/day augmentation of FDA-approved antidepressant treatment
Group II: PlaceboPlacebo Group1 Intervention
no augmentation of FDA-approved antidepressant treatment
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Suvorexant
FDA approved

Find a Location

Who is running the clinical trial?

Institute for Advanced Medical Research, Alpharetta, GALead Sponsor
1 Previous Clinical Trials
60 Total Patients Enrolled
Augusta University, Dept. of PsychiatryUNKNOWN
Angelo Sambunaris, MDPrincipal InvestigatorInstitute for Advanced Medical Research

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Six Week, Randomized, Double-Blind Placebo-Controlled, Suvorexant Augmentation Study of Antidepressant Treatment of Major Depressive Disorder With Residual Insomnia
2017. "A Six Week, Randomized, Double-Blind Placebo-Controlled, Suvorexant Augmentation Study of Antidepressant Treatment of Major Depressive Disorder With Residual Insomnia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02669030.
All > Mdd > Belsomra
~9 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top