A Six Week, Randomized, Double-Blind Placebo-Controlled, Suvorexant Augmentation Study of Antidepressant Treatment of Major Depressive Disorder With Residual Insomnia

• Status: Unknown status
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institute for Advanced Medical Research, Alpharetta, GA
• Collaborators: Augusta University, Dept. of Psychiatry; Jefferson Medical College of Thomas Jefferson University; Medical College of Georgia at Augusta University, Department of Psychiatry and Health Behavior, Augusta, GA
• Treatments: Antidepressive Agents; Suvorexant

Criteria

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