Clinical trial NCT02669030: A Six Week, Randomized, Double-Blind Placebo-Controlled, Suvorexant Augmentation Study of Antidepressant Treatment of Major Depressive Disorder With Residual Insomnia
Official title: A Six Week, Randomized, Double-Blind Placebo-Controlled, Suvorexant Augmentation Study of Antidepressant Treatment of Major Depressive Disorder With Residual Insomnia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Depression
Major Depressive Disorder
MDD
Insomnia
Lead sponsor: Institute for Advanced Medical Research, Alpharetta, GA
Sponsor class: OTHER
Collaborators: name: Augusta University, Dept. of Psychiatry
First posted: 2016-01-29
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Total Sleep Time
timeFrame: Six weeks ( baseline to end of treatment)
Secondary outcomes:
measure: Insomnia Severity Index (ISI)
timeFrame: Six weeks ( baseline to end of treatment)
measure: Hamilton Depression Rating Scale
timeFrame: Six weeks ( baseline to end of treatment)
measure: Sheehan Disability Scale
timeFrame: Six weeks ( baseline to end of treatment)
measure: Wake After Sleep Onset (WASO)
timeFrame: Six weeks ( baseline to end of treatment)
measure: Sleep Latency (SL)
timeFrame: Six weeks ( baseline to end of treatment)
measure: Perceived Deficits Questionnaire (PDQ)
timeFrame: Six weeks ( baseline to end of treatment)
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Institute for Advanced Medical Research @ Mercer Univeristy
state: Georgia
city: Augusta
country: United States
facility: Medical College of GA at Augusta Univeristy
state: Georgia
Study officials:
affiliation: Institute for Advanced Medical Research
name: Angelo Sambunaris, MD
role: PRINCIPAL_INVESTIGATOR
References: