A Study of Oral Seltorexant as an add-on Medication to an Antidepressant on On-road Driving Performance in Participants With Major Depressive Disorder
NCT ID: NCT04451187
Last Updated: 2025-04-27
Study Results
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Basic Information
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COMPLETED
PHASE1
63 participants
INTERVENTIONAL
2020-07-16
2023-03-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
DOUBLE
Study Groups
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Treatment Sequence CADB
Participants will receive placebo once daily (OD) at bedtime for 8 consecutive days from Day 1 to Day 8 (Treatment C) in Period 1 followed by Dose 1 of seltorexant tablets and placebo OD at bedtime for 8 consecutive days from Day 1 to Day 8 (Treatment A) in Period 2 followed by Dose 2 of seltorexant tablets OD at bedtime for 8 consecutive days from Day 1 to Day 8 (Treatment D) in Period 3 followed by zopiclone on Day 1 and Day 8 and placebo from Day 2 to Day 7 OD at bedtime (Treatment B) in Period 4. There will be a washout period of 5 to 21 days between each period.
Seltorexant Dose 1
Participants will receive Dose 1 of seltorexant OD from Day 1 to Day 8 as part of Treatment A as per assigned treatment sequence.
Seltorexant Dose 2
Participants will receive Dose 2 of seltorexant OD from Day 1 to Day 8 as part of Treatment D as per assigned treatment sequence.
Placebo
Participants will receive placebo of seltorexant OD from Day 1 to Day 8 as a part of Treatment A and C and from Day 2 and Day 7 as a part of Treatment B as per assigned treatment sequence.
Zopiclone
Participants will receive Dose 3 of zopiclone OD from Day 1 to Day 8 as a part of Treatment B as per assigned treatment sequence.
Treatment Sequence ABCD
Participants will receive Treatment A in Period 1 followed by Treatment B in Period 2 followed by Treatment C in Period 3 followed by Treatment D in Period 4. There will be a washout period of 5 to 21 days between each period.
Seltorexant Dose 1
Participants will receive Dose 1 of seltorexant OD from Day 1 to Day 8 as part of Treatment A as per assigned treatment sequence.
Seltorexant Dose 2
Participants will receive Dose 2 of seltorexant OD from Day 1 to Day 8 as part of Treatment D as per assigned treatment sequence.
Placebo
Participants will receive placebo of seltorexant OD from Day 1 to Day 8 as a part of Treatment A and C and from Day 2 and Day 7 as a part of Treatment B as per assigned treatment sequence.
Zopiclone
Participants will receive Dose 3 of zopiclone OD from Day 1 to Day 8 as a part of Treatment B as per assigned treatment sequence.
Treatment Sequence BDAC
Participants will receive Treatment B in Period 1 followed by Treatment D in Period 2 followed by Treatment A in Period 3 followed by Treatment C in Period 4. There will be a washout period of 5 to 21 days between each period.
Seltorexant Dose 1
Participants will receive Dose 1 of seltorexant OD from Day 1 to Day 8 as part of Treatment A as per assigned treatment sequence.
Seltorexant Dose 2
Participants will receive Dose 2 of seltorexant OD from Day 1 to Day 8 as part of Treatment D as per assigned treatment sequence.
Placebo
Participants will receive placebo of seltorexant OD from Day 1 to Day 8 as a part of Treatment A and C and from Day 2 and Day 7 as a part of Treatment B as per assigned treatment sequence.
Zopiclone
Participants will receive Dose 3 of zopiclone OD from Day 1 to Day 8 as a part of Treatment B as per assigned treatment sequence.
Treatment Sequence DCBA
Participants will receive Treatment D in Period 1 followed by Treatment C in Period 2 followed by Treatment B in Period 3 followed by Treatment A in Period 4. There will be a washout period of 5 to 21 days between each period.
Seltorexant Dose 1
Participants will receive Dose 1 of seltorexant OD from Day 1 to Day 8 as part of Treatment A as per assigned treatment sequence.
Seltorexant Dose 2
Participants will receive Dose 2 of seltorexant OD from Day 1 to Day 8 as part of Treatment D as per assigned treatment sequence.
Placebo
Participants will receive placebo of seltorexant OD from Day 1 to Day 8 as a part of Treatment A and C and from Day 2 and Day 7 as a part of Treatment B as per assigned treatment sequence.
Zopiclone
Participants will receive Dose 3 of zopiclone OD from Day 1 to Day 8 as a part of Treatment B as per assigned treatment sequence.
Interventions
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Seltorexant Dose 1
Participants will receive Dose 1 of seltorexant OD from Day 1 to Day 8 as part of Treatment A as per assigned treatment sequence.
Seltorexant Dose 2
Participants will receive Dose 2 of seltorexant OD from Day 1 to Day 8 as part of Treatment D as per assigned treatment sequence.
Placebo
Participants will receive placebo of seltorexant OD from Day 1 to Day 8 as a part of Treatment A and C and from Day 2 and Day 7 as a part of Treatment B as per assigned treatment sequence.
Zopiclone
Participants will receive Dose 3 of zopiclone OD from Day 1 to Day 8 as a part of Treatment B as per assigned treatment sequence.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants with MDD (not applicable for elderly without MDD) must have 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 MDD having 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 with MDD (not applicable for elderly without MDD) must be receiving and tolerating well any one of the following selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI) 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 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)
21 Years
80 Years
ALL
Yes
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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Anima
Alken, , Belgium
Universitaetsklinikum der RWTH Aachen
Aachen, , Germany
Countries
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Other Identifiers
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42847922MDD1005
Identifier Type: OTHER
Identifier Source: secondary_id
2019-004913-15
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CR108762
Identifier Type: -
Identifier Source: org_study_id
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