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Phase 3 Study of Adjunctive Treatment With Seltorexant in Adult and Elderly Participants With Major Depressive Disorder and Insomnia Symptoms
Depressive Disorder, Major
Clinicaltrials.gov:
EU CTIS:
#2023-509070-36-00
Other:
#42847922MDD3003
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Trials at a glance
Status
Enrolling
Condition
Depressive Disorder, Major
Trial type
Interventional
Trial phase
Phase 3
Investigational
product
product
Placebo
Selective Serotonin Reuptake Inhibitor (SSRI)/Serotonin-Norepinephrine Reuptake Inhibitor (SNRI)
Seltorexant
Age
18 to 74 years old
Biological sex
All
Placebo?
Yes
Trial start date
July 25, 2024
Trial end date
December 30, 2026
CT.gov ID
#NCT06559306
Share the trial ID with your doctor to see if trial participation is right for you. Participation depends on an independent medical assessment.
Phase 3 Study of Adjunctive Treatment With Seltorexant in Adult and Elderly Participants With Major Depressive Disorder and Insomnia Symptoms
The purpose of this study is to know how well seltorexant works, and also to evaluate
safety and maintenance effect of seltorexant compared with placebo as an adjunctive
therapy to an antidepressant in improving depressive symptoms in participants with major
depressive disorder with insomnia symptoms (MDDIS) who have had an inadequate response to
current antidepressant therapy with a selective serotonin reuptake inhibitor (SSRI) or
serotonin-norepinephrine reuptake inhibitor (SNRI).
Primary outcome measures
- Part 1: Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Day 43
- Part 2: Time from Randomization to the First Relapse in Participants Who Achieve a Stable Response
Secondary outcome measures
- Part 1: Change from Baseline in the MADRS Without Sleep Item (MADRS-WOSI) Total Score at Day 43
- Part 1: Change from Baseline in Sleep Disturbance Using the Patient Reported Outcome Measurement Information System-Sleep Disturbance (PROMIS-SD) Short Form 8a T-score at Day 43
- Part 1: Change from Baseline in the MADRS-6 Total Score at Day 43
- Part 1: Percentage of Participants with Response on Depressive Symptoms Scale Based on Montgomery-Asberg Depression Rating Scale (MADRS) Total score From Baseline to Day 43
- Part 1: Change from Baseline in Sleep Disturbance Using the Patient Reported Outcome Measurement Information System-Sleep Disturbance (PROMIS-SD) Short Form (4a) T-score at Day 43
- Part 1: Change from Baseline in Sleep Disturbance Using the Patient Reported Outcome Measurement Information System-Sleep Disturbance (PROMIS-SD) Short Form (10a) T-score at Day 43
- Part 1: Change from Baseline in Patient Health Questionnaire, 9-Item (PHQ-9) Total Score at Day 43
- Part 2: Time from Randomization to the First Relapse in Participants Who Achieve a Stable Remission
- Part 2: Change from Baseline to Endpoint of the DB Maintenance Phase in Sleep Disturbance Using the PROMIS-SD Short Form (8a) T-Score
- Part 2: Change from Baseline to Endpoint of the DB Maintenance Phase in Sleep Disturbance Using the PROMIS-SD Short Form (4a) T-Score
- Part 2: Change from Baseline in Sleep Disturbance Using the Patient Reported Outcome Measurement Information System-Sleep Disturbance (PROMIS-SD) Short Form (10a) T-score at Day 43
- Part 2: Change from Baseline to Endpoint of the DB Maintenance Phase in MADRS Total Score
- Part 2: Change from Baseline to Endpoint of DB Maintenance Phase in PHQ-9 Score
- Change From Baseline to Endpoint of the DB Maintenance Phase in the MADRS-6 score
- Change from Baseline to Endpoint of the DB Maintenance Phase in the MADRS symptoms other than insomnia MADRS Without Sleep Item (MADRS-WOSI)
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