drugset / Trial / NCT02669030
A Six Week, Randomized, Double-Blind Placebo-Controlled, Suvorexant Augmentation Study of Antidepressant Treatment of Major Depressive Disorder With Residual Insomnia
Phase 4
Unknown
74 enrolled
Institute for Advanced Medical Research, Alpharetta, GA
Augusta University, Dept. of Psychiatry · collab
RandomizedParallel-groupDouble-blindTreatment
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.
Timeline
- Start
- 2017-03-01
- Primary completion
- 2019-12
- Completion
- 2019-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Suvorexant | Small molecule | 10 mg | — |
| Subject | Suvorexant | Small molecule | 15 mg | — |
| Subject | Suvorexant | Small molecule | 20 mg | — |