A Six Week, Randomized, Double-Blind Placebo-Controlled, Suvorexant Augmentation Study of Antidepressant Treatment of Major Depressive Disorder With Residual Insomnia
1 other identifier
interventional
74
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 depression
Started Mar 2017
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 27, 2016
CompletedFirst Posted
Study publicly available on registry
January 29, 2016
CompletedStudy Start
First participant enrolled
March 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedFebruary 27, 2019
February 1, 2019
2.8 years
January 27, 2016
February 25, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Total Sleep Time
assessment of total amount of time spent sleeping
Six weeks ( baseline to end of treatment)
Secondary Outcomes (6)
Insomnia Severity Index (ISI)
Six weeks ( baseline to end of treatment)
Hamilton Depression Rating Scale
Six weeks ( baseline to end of treatment)
Sheehan Disability Scale
Six weeks ( baseline to end of treatment)
Wake After Sleep Onset (WASO)
Six weeks ( baseline to end of treatment)
Sleep Latency (SL)
Six weeks ( baseline to end of treatment)
- +1 more secondary outcomes
Study Arms (2)
Suvorexant
EXPERIMENTALsuvorexant 10mg/day, 15mg/day or 20mg/day augmentation of FDA-approved antidepressant treatment
Placebo
PLACEBO COMPARATORno augmentation of FDA-approved antidepressant treatment
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Institute for Advanced Medical Research @ Mercer Univeristy
Atlanta, Georgia, 30341, United States
Medical College of GA at Augusta Univeristy
Augusta, Georgia, 30912, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Angelo Sambunaris, MD
Institute for Advanced Medical Research
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 27, 2016
First Posted
January 29, 2016
Study Start
March 1, 2017
Primary Completion
December 1, 2019
Study Completion
December 1, 2019
Last Updated
February 27, 2019
Record last verified: 2019-02