Depression, Insomnia, Major Depressive Disorder, MDD
Conditions
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.
Detailed description
Many patients with depression suffer from residual insomnia. This study is a six week, randomized, double-blind, placebo-controlled, trial to study suvorexant augmentation of continuing antidepressant therapy against placebo with continuing antidepressant therapy. Patient volunteers must be on a stable antidepressant treatment and will remain on this treatment for the duration of the study. Patient volunteers that qualify and enroll in the clinical trial will either receive suvorexant 10 mg/day and may have it adjusted to a dose of either 15 mg or 20 mg/day. Treatment is for a total of six weeks in addition to a clinical follow-up visit.
Interventions
DRUGsuvorexant
an FDA-approved sleep aid
DRUGPlacebo
control group
Sponsors
Augusta University, Dept. of Psychiatry
Institute for Advanced Medical Research, Alpharetta, GA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Sleep Time | Six weeks ( baseline to end of treatment) | assessment of total amount of time spent sleeping |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hamilton Depression Rating Scale | Six weeks ( baseline to end of treatment) | assessment fo depressive symptom severity |
| Sheehan Disability Scale | Six weeks ( baseline to end of treatment) | assessment of impact of symptoms on performance |
| Insomnia Severity Index (ISI) | Six weeks ( baseline to end of treatment) | assessment of insomnia severity |
| Sleep Latency (SL) | Six weeks ( baseline to end of treatment) | assessment of amount of time it takes to fall asleep |
| Perceived Deficits Questionnaire (PDQ) | Six weeks ( baseline to end of treatment) | a brief patient-rated scale to assess subjective cognitive dysfunction in people with depression |
| Wake After Sleep Onset (WASO) | Six weeks ( baseline to end of treatment) | assessment of amount of time spent awake after initial onset of sleep |
Countries
United States
Contacts
Primary ContactBrandon Lenfest, BS
Outcome results
None listed