DepressionPhase 4NCT02669030
A Six Week, Randomized, Double-Blind Placebo-Controlled, Suvorexant Augmentation Study of Antidepressant Treatment of Major Depressive Disorder With Residual Insomnia
A Phase 4 study testing suvorexant in people with Depression and Major Depressive Disorder, run by Institute for Advanced Medical Research, Alpharetta, GA at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Depression, Major Depressive Disorder, MDD
- What is being tested?
- suvorexant
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Mar 2017to Dec 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provide written Informed Consent
- Diagnosis of depression (MDD)
- Currently on antidepressant
- Healthy and/or stable medically
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Institute for Advanced Medical Research @ Mercer Univeristy
Atlanta, Georgia, 30341
Anna Kerlin, BS, 770-817-9200, info@iamresearch.org
Angelo Sambunaris, MD
- Recruiting
Medical College of GA at Augusta Univeristy
Augusta, Georgia, 30912
Vaughn McCall, MD
About this study
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.
Read the 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.
- Conditions
- Depression, Major Depressive Disorder, MDD, Insomnia
- Being tested
- suvorexant, Placebo
- Medical subject headings
- Depression, Depressive Disorder, Major, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
suvorexantDrug
Also called Belsomra®
an FDA-approved sleep aid
PlaceboDrug
control group
| Study group | Role | What they receive |
|---|---|---|
| Suvorexant | Experimental | suvorexant 10mg/day, 15mg/day or 20mg/day augmentation of FDA-approved antidepressant treatment Receives: Drug: suvorexant |
| Placebo | Placebo comparator | no augmentation of FDA-approved antidepressant treatment Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Sleep Time
assessment of total amount of time spent sleeping
Measured: Six weeks ( baseline to end of treatment)
Secondary outcomes (6)
Insomnia Severity Index (ISI)
assessment of insomnia severity
Measured: Six weeks ( baseline to end of treatment)
Hamilton Depression Rating Scale
assessment fo depressive symptom severity
Measured: Six weeks ( baseline to end of treatment)
Sheehan Disability Scale
assessment of impact of symptoms on performance
Measured: Six weeks ( baseline to end of treatment)
Wake After Sleep Onset (WASO)
assessment of amount of time spent awake after initial onset of sleep
Measured: Six weeks ( baseline to end of treatment)
Sleep Latency (SL)
assessment of amount of time it takes to fall asleep
Measured: Six weeks ( baseline to end of treatment)
Perceived Deficits Questionnaire (PDQ)
a brief patient-rated scale to assess subjective cognitive dysfunction in people with depression
Measured: Six weeks ( baseline to end of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2016 (estimated)
- Study start1 Mar 2017
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute for Advanced Medical Research, Alpharetta, GA
- Sponsor type
- University, hospital or other
- Collaborators
- Augusta University, Dept. of Psychiatry
- Responsible party
- Sponsor
- Investigators
- Angelo Sambunaris, MD, Principal investigator, Institute for Advanced Medical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02669030
- Sponsor's protocol ID
- SVX-IIT2016-001
- Status last verified
- Feb 2019
- First submitted
- 27 Jan 2016
- Last updated
- 27 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Six Week, Randomized, Double-Blind Placebo-Controlled, Suvorexant Augmentation Study of Antidepressant Treatment of Major Depressive Disorder With Residual Insomnia
- ClinicalTrials.gov ID
- NCT02669030
- Acronym / sponsor ID
- SVX-IIT2016-001
- Conditions
- Depression, Major Depressive Disorder, MDD, Insomnia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Institute for Advanced Medical Research, Alpharetta, GAUniversity, hospital or other
- Collaborators
- Augusta University, Dept. of Psychiatry
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 29 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Suvorexant | Experimental | Drug: suvorexantsuvorexant 10mg/day, 15mg/day or 20mg/day augmentation of FDA-approved antidepressant treatment |
| Placebo | Placebo comparator | Drug: Placebono augmentation of FDA-approved antidepressant treatment |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Provide written Informed Consent
- Diagnosis of depression (MDD)
- Currently on antidepressant
- Healthy and/or stable medically
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| suvorexantAlso: Belsomra®an FDA-approved sleep aid | Drug | Suvorexant |
| Placebocontrol group | Drug | Placebo |
Primary outcome
Total Sleep Time
Time frame: Six weeks ( baseline to end of treatment)
assessment of total amount of time spent sleeping
6 secondary outcomes
Insomnia Severity Index (ISI)
Time frame: Six weeks ( baseline to end of treatment)
Hamilton Depression Rating Scale
Time frame: Six weeks ( baseline to end of treatment)
Sheehan Disability Scale
Time frame: Six weeks ( baseline to end of treatment)
Wake After Sleep Onset (WASO)
Time frame: Six weeks ( baseline to end of treatment)
Sleep Latency (SL)
Time frame: Six weeks ( baseline to end of treatment)
Perceived Deficits Questionnaire (PDQ)
Time frame: Six weeks ( baseline to end of treatment)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angelo Sambunaris, MD principal investigator
Institute for Advanced Medical Research
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing suvorexant in people with Depression and Major Depressive Disorder, run by Institute for Advanced Medical Research, Alpharetta, GA at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Brandon Lenfest, BS (770-817-9200, info@iamresearch.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Sleep Time (time frame: Six weeks ( baseline to end of treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2019.