A Study of Seltorexant as Monotherapy in Adults and Elderly Participants With Major Depressive Disorder

Condition(s) studied

Investigational drug(s) / intervention(s)

Seltorexant: Seltorexant tablet will be administered orally.

Placebo: Placebo tablet will be administered orally.

Study summary

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.

Eligibility

Primary outcome measure(s)

• 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) — Baseline up to Day 43
  The MADRS is a clinician-administered scale designed to measure depression severity and detects changes due to antidepressant treatment. The scale consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 60. Higher scores represent a more severe condition.
• Open-Label (OL) Treatment Phase: Number of Participants with Adverse Events Including Adverse Event of Special Interests (AESIs) — OL Baseline (Day 43) Up to 6 months
  An AE is any untoward medical occurrence in a clinical study participant administered with a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the intervention. The following AESIs are considered in this study: Suicidal thoughts, suicidal ideation, and suicidal behavior; Cataplexy; Sleep paralysis; Complex, sleep-related behaviors/parasomnias; Fall and Motor vehicle accident.
• OL Treatment Phase: Number of Participants with Vital Signs Abnormalities — OL Baseline (Day 43) Up to 6 months
  Number of participants with vital signs (blood pressure and pulse/heart rate measurements) abnormalities will be reported.
• OL Treatment Phase: Number of Participants with Suicidality Assessment using Columbia-Suicide Severity Rating Scale (C-SSRS) — OL Baseline (Day 43) Up to 6 months
  The C-SSRS is a low-burden measure of the spectrum of suicidal ideation and behavior that was developed to assess severity and track suicidal events through any treatment. The C-SSRS scale consists of 28 items in 4 sections: suicide behavior, actual attempts, suicidal ideation, and intensity of ideation. Suicidal ideation consists of 5 'yes/no' items: wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods (not plan) without intention to act, active suicidal ideation with some intent to act without specific plan, active suicidal ideation with specific plan and intent.
• OL Treatment Phase: Number of Participants with Withdrawal Symptoms Assessment Using Physician Withdrawal Checklist (PWC-20) — End of Treatment/Early withdrawal to end of the Follow-up visit (up to 14 days)
  Potential withdrawal effects will be assessed by the PWC-20. The PWC-20 is a simple and accurate method used to assess potential withdrawal symptoms following cessation of treatment. The PWC-20 is a reliable and sensitive instrument for the assessment of discontinuation symptoms.
• OL Treatment Phase: Number of Participants with Abnormalities in Electrocardiogram (ECG) — OL Baseline (Day 43) up to 6 months
  Number of participants with abnormalities in ECG will be reported.
• OL Treatment Phase: Number of Participants Reporting Sexual Functioning using Arizona Sexual Experiences Scale (ASEX) — Up to 6 months
  The ASEX is a patient-reported 5-item rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm. Possible total scores range from 5 to 30, with the higher scores indicating more sexual dysfunction. The scale has shown satisfactory reliability and validity.
• OL Treatment Phase: Change from Baseline in the Body Weight — OL Baseline (Day 43) up to 6 months
  Change from baseline in body weight will be reported.
• OL Treatment Phase: Change from Baseline in the Body Mass Index (BMI) — OL Baseline (Day 43) up to 6 months
  Change from baseline in BMI will be reported.
• OL Treatment Phase: Change from Baseline in the Waist Circumference — OL Baseline (Day 43) up to 6 months
  Change from baseline in waist circumference will be reported.
• OL Treatment Phase: Number of Participants with Abnormalities in Clinical Laboratory Parameters — OL Baseline (Day 43) up to 6 months
  Number of participants with laboratory abnormalities related to hematology, serum chemistry will be reported.

Trial sites (39)

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