Enrolling Clinical Studies
MAJOR DEPRESSION with INSOMNIA
CLINICAL TRIAL
This study will evaluate the efficacy, safety and maintenance of effect of Seltorexant, an orally medication as adjunctive therapy to antidepressants in adults and elderly with Major Depressive Disorder with Insomnia symptoms.
Requirements:
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Men or women between 18 and 74 years of age.
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Subjects with BMI between 18 and 40 kg/m².
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Have a diagnosis of Major Depression Disorder (MDD) without psychotic features.
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Subject must have had first depressive episode prior to 60 years of age.
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Subject with no improvement to at least 1 but no more than 2 antidepressants.
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The current antidepressant cannot be the first lifetime treatment for depression.
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Subject currently taking and tolerating well one of the following SSRI or SNRI: citalopram, duloxetine, escitalopram, fluvoxamine, fluoxetine, milnacipran, levomilnacipran, paroxetine, sertraline, venlafaxine, desvenlafaxine, vilazodone, or vortioxetine for at least 6 weeks.
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No subjects with history of renal insufficiency, uncontrolled diabetes, unstable cardiovascular, respiratory, gastrointestinal, neurologic, hematologic, rheumatologic, immunologic disorders.
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No history of narcolepsy and seizures, or significant hepatic disease.
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Subject with pre-existing thyroid disorder need to be on stable dosage 3-month prior D1.
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Not have recent history of homicidal/suicidal ideation within the past 6 months prior to D1.
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No subjects with primary diagnosis of panic disorder, anxiety, OCD, PTSD, anorexia, bipolar disorder, psychotic disorder, autism, uncontrolled sleep disorder.
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No history of moderate to severe substance use disorder including alcohol or benzodiazepines.
Study Duration:
This study consists of a total of 8 visits and 3 telephone contacts over a period of 8 weeks.
Compensation:
This study will pay $125 per in-clinic visit and $25 per telephone contact. A total of $950 for completing the study.