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Suvorexant for Schizophrenia

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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up six weeks ( baseline to end of treatment)
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
Pivotal Trial
Drug Has Already Been Approved

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
  • Schizophrenia
  • Insomnia

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Total Sleep Time
Secondary study objectives
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

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

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
~9 spots leftby Nov 2025
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