A Six Week, Randomized, Double-Blind Placebo-Controlled, Suvorexant Augmentation Study of Antidepressant Treatment of Major Depressive Disorder With Residual Insomnia
Status unconfirmed · Phase 4 · Has a placebo group
Conditions studied: Depression, Major Depressive Disorder, MDD, Insomnia
In brief
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.
Key facts
- Study ID
- NCT02669030
- Run by
- Institute for Advanced Medical Research, Alpharetta, GA
- People needed
- 74
- Starts
- 2017-03-01
- Expected to finish
- 2019-12-01
- Last updated by the study team
- 2019-02-27
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Provide written Informed Consent
- Diagnosis of depression (MDD)
- Currently on antidepressant
- Healthy and/or stable medically
You may not qualify if…
- 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
Where it is running
- Institute for Advanced Medical Research @ Mercer Univeristy — Atlanta, Georgia, United States (enrolling)
- Medical College of GA at Augusta Univeristy — Augusta, Georgia, United States (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.