Discover Hope: A New Fast-Acting Medication for Major Depressive Disorder
Susan Conroy, MD PhD
Primary Investigator
Brief description of study
When you’re living with Major Depressive Disorder (MDD), you know all too well how challenging everyday life can become. The struggle to find effective relief can lead to feelings of hopelessness and frustration. But there is hope.
This new research study is looking at a fast-acting medication designed to help improve symptoms more quickly than traditional treatments. By participating, you can play a vital role in discovering a potential breakthrough for yourself and others who are battling this condition.
Detailed description of study
What you can expect:
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 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.
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
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.
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.
