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A Study of Seltorexant as Monotherapy in Adults and Elderly Participants With Major Depressive Disorder
Depressive Disorder, Major
Clinicaltrials.gov:
Other:
#42847922MDD3011
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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
Seltorexant
Age
18 to 74 years old
Biological sex
All
Placebo?
Yes
Trial start date
April 30, 2026
Trial end date
May 3, 2029
CT.gov ID
#NCT07573176
Share the trial ID with your doctor to see if trial participation is right for you. Participation depends on an independent medical assessment.
A Study of Seltorexant as Monotherapy in Adults and Elderly Participants With Major Depressive Disorder
The main purpose of this study is to assess how well the study drug (JNJ-42847922) works (efficacy) compared with placebo in improving depressive symptoms in participants with major depressive disorder ([MDD], a common mood disorder that causes a lasting feeling of sadness and a loss of interest in everyday activities) in double-blind treatment phase. Further, to evaluate long-term safety and tolerability of JNJ-42847922 in participants with MDD in the open label treatment phase.
Primary outcome measures
- Double Blind (DB) Treatment Phase: Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score in Participants with Major Depressive Disorder with Moderate-to-Severe Insomnia Symptoms (MDDIS)
- Open-Label (OL) Treatment Phase: Number of Participants with Adverse Events Including Adverse Event of Special Interests (AESIs)
- OL Treatment Phase: Number of Participants with Vital Signs Abnormalities
- OL Treatment Phase: Number of Participants with Suicidality Assessment using Columbia-Suicide Severity Rating Scale (C-SSRS)
- OL Treatment Phase: Number of Participants with Withdrawal Symptoms Assessment Using Physician Withdrawal Checklist (PWC-20)
- OL Treatment Phase: Number of Participants with Abnormalities in Electrocardiogram (ECG)
- OL Treatment Phase: Number of Participants Reporting Sexual Functioning using Arizona Sexual Experiences Scale (ASEX)
- OL Treatment Phase: Change from Baseline in the Body Weight
- OL Treatment Phase: Change from Baseline in the Body Mass Index (BMI)
- OL Treatment Phase: Change from Baseline in the Waist Circumference
- OL Treatment Phase: Number of Participants with Abnormalities in Clinical Laboratory Parameters
Secondary outcome measures
- DB Treatment Phase: Change from Baseline in MADRS-Without Sleep Item (WOSI) Total Score
- DB Treatment Phase: Change from Baseline in Sleep Disturbance using Patient Reported Outcome Measurement Information System-Sleep Disturbance (PROMIS-SD) Short Form 10a(8a + 2a ) T-score
- DB Treatment phase: Change from Baseline in MADRS-6 Total Score
- DB Treatment Phase: Proportion of Participants with Response on Depressive Symptoms Scale
- DB Treatment Phase: Change from Baseline in Sleep Disturbance using PROMIS-SD Short Form 8a T-Score
- DB Treatment Phase: Change from Baseline in Patient Health Questionnaire 9-Item (PHQ-9) Total Score
- DB Period: Change from Baseline in Work Productivity and Activity Impairment Questionnaire, Depression (WPAI-D) Scores
- OL Treatment Phase: Change from Baseline Over Time in MADRS Total Score
- OL Treatment Phase: Change from Baseline Over Time in Clinical Global Impression-Severity (CGI-S) Score
- OL Treatment Phase: Change from Baseline Over Time in MADRS-WOSI Total Score
- OL Treatment Phase: Change from Baseline Over Time in Sleep Disturbance using PROMIS-SD Short Form 10a(8a+2a) T-score
- OL Treatment Phase: Change from Baseline in Work Productivity and Activity Impairment-Questionnaire Depression (WPAI-D) Score
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