Phase 3 Sleep Disorders Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You have been diagnosed with major depressive disorder (a serious form of depression) without hallucinations or delusions, and your first episode of depression began before age 60
- Your current depression has not improved enough (less than 50% better, but at least some improvement) with 1 or 2 antidepressant medications tried at the right dose and for long enough during your current episode
- You are currently taking — and tolerating well — one of the following antidepressants at a stable dose for at least 6 weeks: citalopram, duloxetine, escitalopram, fluvoxamine, fluoxetine, milnacipran, levomilnacipran, paroxetine, sertraline, venlafaxine, desvenlafaxine, vilazodone, or vortioxetine
- Your depression is at least moderate in severity, confirmed by a structured rating interview, and has not significantly improved during the screening period
- (For people continuing from Part 1 of the study) You completed the first part of the trial, tolerated the study medication well, followed the study procedures consistently, and are in stable overall health based on lab tests
Who may not be able to join:
- You have had, in the last 3 months or currently have, serious kidney problems, or unstable/significant heart, lung, digestive, neurological, blood, joint, immune, or hormonal conditions, or poorly controlled Type 1 or Type 2 diabetes
- You have a history of narcolepsy (a sleep disorder) or seizures
- You currently have signs or symptoms of an underactive or overactive thyroid
- You are taking thyroid medication specifically to help treat your depression
- You have certain hormonal or gland-related conditions, such as Cushing's disease, Addison's disease, primary amenorrhea (never having had a menstrual period), or other significant disorders affecting the body's stress hormone system (confirm with trial site)
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Janssen Research & Development, LLC Clinical Trail, Janssen Research & Development, LLC
Phone: 844-434-4210
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
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
Can't join this trial?
Data last synced from ClinicalTrials.gov: 8 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.