A Study of Oral Seltorexant as an add-on Medication to an Antidepressant on On-road Driving Performance in Participants With Major Depressive Disorder

  • STATUS
    Recruiting
  • participants needed
    64
  • sponsor
    Janssen Research & Development, LLC
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Updated on 16 February 2024
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depressive symptoms
anxiety
antidepressants
depressive disorder
psychiatric disorder
sertraline
citalopram
psychosis
venlafaxine
selective serotonin reuptake inhibitors
fluoxetine
paroxetine
duloxetine
depression
norepinephrine
major depressive disorder
social phobia
vortioxetine
desvenlafaxine
norepinephrine reuptake inhibitor
noradrenaline
serotonin reuptake inhibitors
vilazodone
levomilnacipran
serotonin and norepinephrine reuptake inhibitors

Summary

The purpose of the study is to evaluate the effect of seltorexant, compared to placebo, as an add-on medication to an antidepressant, on next-day driving performance as assessed by the mean difference of standard deviation of lateral position (SDLP) from an on-road driving test.

Details
Condition Major depression
Age 21years - 80years
Treatment Placebo, Seltorexant Dose 1, Seltorexant Dose 2, Zopiclone
Clinical Study IdentifierNCT04451187
SponsorJanssen Research & Development, LLC
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Participant must meet Diagnostic and Statistical Manual of Mental Disorders-5th Edition (DSM-5) diagnostic criteria for major depressive disorder (MDD) without psychotic features based upon clinical assessment (DSM-5 296.20, 296.21, 296.25, 296.26, 296.30, 296.31, 296.35 or 296.36) and confirmed by the Mini International Neuropsychiatric Interview (MINI) and the attending general physician, psychiatrist or mental health practitioner
Participants with mild or better depressive symptoms indicated by a Montgomery-Asberg Depression Rating Scale (MADRS) total score of less than or equal to (<=) 18 at screening
Participants with comorbid generalized anxiety disorder, social anxiety disorder, or panic disorder for whom major depressive disorder (MDD) is considered the primary diagnosis are not excluded
Participants receiving and tolerating well any one of the following selective serotonin reuptake inhibitor (SSRIs) or serotonin-norepinephrine reuptake inhibitor (SNRIs) for depressive symptoms in any formulation and available in the participating country: citalopram, duloxetine, escitalopram, fluoxetine, milnacipran, levomilnacipran, paroxetine, sertraline, venlafaxine, desvenlafaxine, vilazodone, or vortioxetine at a stable dose (at therapeutic dose level) for at least 4 weeks prior to screening, and expected to continue to take the same drug and dose for the duration of the study
Participant should be medically stable on the basis of medical history, neurological examination and clinical laboratory tests performed at screening, and physical examination, vital signs, and 12-lead electrocardiogram (ECG) performed at screening and predose on Day 1 of Period 1

Exclusion Criteria

Participants has a recent (last 3 months) history of, or current signs and symptoms of severe renal insufficiency (creatinine clearance less than [<]30 milliliter per minute [mL/min]); clinically significant or unstable cardiovascular, respiratory, gastrointestinal, neurologic, hematologic, rheumatologic, immunologic or endocrine disorders; and participants with uncontrolled type 1 or type 2 diabetes mellitus
Participants has clinically significant hepatic disease as defined by greater than or equal to (>=) 2 Upper Limit of Normal [ULN]) increase of aspartate aminotransferase (AST) or alanine aminotransferase (ALT) at screening (one retest is permitted); and significant liver disease including cirrhosis, ascites, active hepatitis etc. (fatty liver disease or Gilbert's syndrome will be allowed as long as it does not meet the above criteria)
Participants has current signs/symptoms of hypothyroidism or hyperthyroidism. For participants with a history of thyroid disease and for participants who, regardless of thyroid history have the thyroid stimulating hormone (TSH) value out of range, a free thyroxine (FT4) test will be conducted. If the FT4 value is abnormal and considered to be clinically significant (after discussion with the medical monitor) the participant is not eligible. Participants with a pre-existing history of thyroid disease/disorder who are treated with thyroid hormones need to be on a stable dosage for 3 months prior to the start of the screening phase. Participants taking thyroid supplementation for antidepressant purposes are not allowed in the study
Participants has Cushing's Disease, Addison's Disease, primary amenorrhea, or other evidence of significant medical disorders of the hypothalamic-pituitary-adrenal (HPA) axis
Participants has a lifetime history of narcolepsy and seizures (except childhood seizures)
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depressive symptoms
anxiety
antidepressants
depressive disorder
psychiatric disorder
sertraline
citalopram
psychosis
venlafaxine
selective serotonin reuptake inhibitors
fluoxetine
paroxetine
duloxetine
depression
norepinephrine
major depressive disorder
social phobia
vortioxetine
desvenlafaxine
norepinephrine reuptake inhibitor
noradrenaline
serotonin reuptake inhibitors
vilazodone
levomilnacipran
serotonin and norepinephrine reuptake inhibitors

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