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.
Age range
18 Years – 74 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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)
Timeframe: Baseline up to Day 43
Open-Label (OL) Treatment Phase: Number of Participants with Adverse Events Including Adverse Event of Special Interests (AESIs)
Timeframe: OL Baseline (Day 43) Up to 6 months
OL Treatment Phase: Number of Participants with Vital Signs Abnormalities
Timeframe: OL Baseline (Day 43) Up to 6 months
OL Treatment Phase: Number of Participants with Suicidality Assessment using Columbia-Suicide Severity Rating Scale (C-SSRS)
Timeframe: OL Baseline (Day 43) Up to 6 months
OL Treatment Phase: Number of Participants with Withdrawal Symptoms Assessment Using Physician Withdrawal Checklist (PWC-20)
Timeframe: End of Treatment/Early withdrawal to end of the Follow-up visit (up to 14 days)
OL Treatment Phase: Number of Participants with Abnormalities in Electrocardiogram (ECG)
Timeframe: OL Baseline (Day 43) up to 6 months
OL Treatment Phase: Number of Participants Reporting Sexual Functioning using Arizona Sexual Experiences Scale (ASEX)
Timeframe: Up to 6 months
OL Treatment Phase: Change from Baseline in the Body Weight
Timeframe: OL Baseline (Day 43) up to 6 months
OL Treatment Phase: Change from Baseline in the Body Mass Index (BMI)
Timeframe: OL Baseline (Day 43) up to 6 months
OL Treatment Phase: Change from Baseline in the Waist Circumference
Timeframe: OL Baseline (Day 43) up to 6 months
OL Treatment Phase: Number of Participants with Abnormalities in Clinical Laboratory Parameters
Timeframe: OL Baseline (Day 43) up to 6 months