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| Name | Class |
|---|---|
| Augusta University, Dept. of Psychiatry | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Suvorexant | Experimental | suvorexant 10mg/day, 15mg/day or 20mg/day augmentation of FDA-approved antidepressant treatment |
|
| Placebo | Placebo Comparator | no augmentation of FDA-approved antidepressant treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| suvorexant | Drug | an FDA-approved sleep aid |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Sleep Time | assessment of total amount of time spent sleeping | Six weeks ( baseline to end of treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| Insomnia Severity Index (ISI) | assessment of insomnia severity | Six weeks ( baseline to end of treatment) |
| Hamilton Depression Rating Scale | assessment fo depressive symptom severity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Brandon Lenfest, BS | Contact | 770-817-9200 | info@iamresearch.org |
| Name | Affiliation | Role |
|---|---|---|
| Angelo Sambunaris, MD | Institute for Advanced Medical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute for Advanced Medical Research @ Mercer Univeristy | Recruiting | Atlanta | Georgia | 30341 | United States |
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| Placebo | Drug | control group |
|
| Six weeks ( baseline to end of treatment) |
| Sheehan Disability Scale | assessment of impact of symptoms on performance | Six weeks ( baseline to end of treatment) |
| Wake After Sleep Onset (WASO) | assessment of amount of time spent awake after initial onset of sleep | Six weeks ( baseline to end of treatment) |
| Sleep Latency (SL) | assessment of amount of time it takes to fall asleep | 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 | Six weeks ( baseline to end of treatment) |
| Medical College of GA at Augusta Univeristy | Recruiting | Augusta | Georgia | 30912 | United States |
|
| ID | Term |
|---|---|
| D003863 | Depression |
| D003865 | Depressive Disorder, Major |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C551624 | suvorexant |
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