Recruiting

Suvorexant

Sponsor:

Institute for Advanced Medical Research, Alpharetta, GA

Code:

NCT02669030

Conditions

Depression

Major Depressive Disorder

MDD

Insomnia

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

suvorexant

Placebo

Study Details

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.

Conditions

Depression

Major Depressive Disorder

MDD

Insomnia

Study ID

NCT02669030

Start date

Mar 1, 2017

Status verified date

Feb, 2019

Completion date

Dec, 2019

Anticipated

Primary completion date

Dec, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

74 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Suvorexant

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

placebo comparator: Placebo

no augmentation of FDA-approved antidepressant treatment

Interventions

suvorexant

an FDA-approved sleep aid

Placebo

control group

Primary outcome measure

  • Total Sleep Time [ Time Frame: Six weeks ( baseline to end of treatment) ]

Central Contacts and Locations

Central contacts

Locations

Institute for Advanced Medical Research @ Mercer Univeristy

Recruiting

Atlanta, Georgia, United States, 30341

Contacts

Principal Investigator:

Angelo Sambunaris, MD

Medical College of GA at Augusta Univeristy

Recruiting

Augusta, Georgia, United States, 30912

Principal Investigator:

Vaughn McCall, MD

More Information

Sponsor

Institute for Advanced Medical Research, Alpharetta, GA

Last update posted

Feb 27, 2019

Last verified

Feb, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Institute for Advanced Medical Research, Alpharetta, GA on 2019-02-27.