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ADULTS NEEDED FOR DEPRESSION STUDY
S
Susan Conroy, MD PhD
Primary Investigator
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Recruiting
18 years - 64 years
All
Phase
N/A
3 participants needed
1 Location
Brief description of study
What is the purpose of this study?
The main purpose of this study is to see how well a new medicine, called JNJ-89495120, works for people with major depressive disorder (MDD). This medicine is being tested as a monotherapy, which means it is used on its own (not with other antidepressants). It is designed to be fast-acting, which means it may help improve symptoms more quickly than traditional treatments.
First, there is a Screening Phase, where doctors will make sure it is safe for you to take part. This may include stopping some of your current medicines if needed.
Next, you will enter a 2-week treatment phase. During this time, neither you nor the study team will know which treatment you are receiving. You will either:
- Get the study medicine (JNJ-89495120) two times a week with “dummy” pills (placebos) on the other days, or
- Get only placebo pills every day.
After the treatment phase, there will be a 2-week period without antidepressants. This helps researchers see how long the effects of the treatment last and check on safety.
Finally, you will have a follow-up phase with regular care that may last up to 6 weeks.
Detailed description of study
What will happen during the study?
The primary objective of this study is to investigate the efficacy of JNJ-89495120 as a monotherapy in
participants with MDD.
After completing a Screening Phase, which includes an as-needed medication wash-out, participants will receive the double-blind treatment for 2 weeks, which will consist of either active treatment (intermittent, twice-weekly) of JNJ-89495120 (with placebo doses between the active treatment days)or placebo daily. The double-blind treatment phase is followed by an observational 2-week antidepressant-free phase to assess durability of effect and safety. After the completion of the observational phase, participants enter a standard of care (SOC)follow-up phase that lasts up to 6 weeks.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Major depressive disorder, MDD
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Age: 18 years - 64 years
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Gender: All
Here’s a rewritten 8th grade, patient-friendly version of the inclusion and exclusion criteria:
Who Can Join the Study (Inclusion Criteria)
You may be able to take part in this study if:
- Your main diagnosis is major depressive disorder (MDD) that comes back more than once, and you do not have psychotic symptoms (such as hallucinations or delusions).
- A doctor has confirmed your diagnosis using standard tools, including a short interview called the MINI.
- You have had at least one past episode of depression before your current episode.
- You were first diagnosed with depression before age 55.
- You are currently in a depressive episode that has lasted at least 2 months but not more than 24 months.
- You have tried 0, 1, or 2 treatments for depression during your current episode.
- Your body mass index (BMI) is between 18 and 35.
Who Cannot Join the Study (Exclusion Criteria)
You may not be able to take part if:
- You have had treatments such as ECT (electroconvulsive therapy), TMS (transcranial magnetic stimulation), VNS (vagus nerve stimulation), DBS (deep brain stimulation), or ketamine/esketamine during your current or past depression episodes.
- You have (or have had) certain mental health conditions, such as bipolar disorder, psychotic disorders, borderline or antisocial personality disorder, or current obsessive-compulsive disorder (OCD).
- You have had post-traumatic stress disorder (PTSD) within the last 3 years.
- You have dementia, memory problems, intellectual disability, or another brain disorder that affects thinking.
- You have had an alcohol or drug use disorder in the past 6 months (except for nicotine, caffeine, or mild cannabis use).
- You are allergic to or cannot tolerate the study medicine JNJ-89495120 or anything it contains.
Updated on
13 Oct 2025.
Study ID: PSYC-JANSSEN-MOONLIGHT-1, 24724
Pre-Screener
