Double-blind, Placebo-controlled Study in Adults With Major Depressive Disorder
Recruiting · Garden Grove, California
Always free
Study care at no cost to you
For your time and travel
Many studies pay you back
Most need no insurance or papers
Legal status usually isn't required; we'll tell you each study's requirements
Interpreters available
Ask for your language
Your choice
Voluntary — you can stop anytime
What is this study?
This study will evaluate the efficacy and safety of SPN-821 in adults with major depressive disorder
It is , overseen by an independent and licensed medical staff.
Read the full clinical description
This study will evaluate the efficacy and safety of SPN-821 in adults with major depressive disorder
Who this study is looking for
In plain language, from the study's own rules. The study team confirms the full details with you — this isn't a final yes or no.
✅ You may be able to join if…
- •Adults with a current diagnosis of major depressive disorder (MDD) based on DSM-5, confirmed by the MINI, with no psychotic features
- •Your current episode of major depression has lasted at least 8 weeks
- •MADRS total score of 24 or higher at both the Screening Visit and Day 1 Visit (MADRS is a depression symptom rating scale)
- •CGI-S score of 4 or higher at both the Screening Visit and Day 1 Visit (CGI-S describes how ill you are overall)
- •You’ve been on a stable, approved antidepressant dose for at least 8 weeks before screening and at least 10 weeks by Day 1, and it has not helped enough (less than 50% improvement on depressive symptoms by ATRQ)
🚫 You may not be able to join if…
- •Your MADRS score changes by 25% or more from the Screening Visit to Day 1 Visit
- •You have a history of treatment-resistant depression (TRD), defined as 3 or more failed adequate antidepressant treatments for this current episode
- •You had alcohol or substance use disorder in the 6 months before screening (DSM-5)
- •The investigator believes you have a significant risk for suicidal behavior during the study
- •You have had certain mental health conditions, such as any lifetime psychotic disorder, bipolar disorder, schizophrenia, autism spectrum disorder, PTSD, a personality disorder, or intellectual disability that could affect enrollment
Are you a good fit?
Simplified highlights. The study team always confirms the full details with you.
- ✓Adults roughly 18–70
- ✓Have Depression
- !Some conditions may not be a fit: Heart / cardiovascular disease, Anxiety
What to expect, step by step
- 1
Usually a few weeks
The study team checks whether the study is a good fit for you, with a visit and sometimes lab tests. You can ask any questions before deciding.
- 2
Treatment
If you join and choose to continue, you receive the study treatment and are watched closely by medical staff.
- 3
Follow-up
After treatment, the team checks on your health and confirms the visit schedule with you. You can leave the study at any point.
Has this treatment been tested before?
Yes. This treatment has already been through earlier human studies for safety before reaching this stage.
What you need to know before you apply
What is this study testing?+
This study will evaluate the efficacy and safety of SPN-821 in adults with major depressive disorder
Is it safe? Who makes sure of that?+
This is a mid-stage study (Phase 2), looking at safety and whether the treatment works. Every study is reviewed and monitored by an independent ethics board (called an IRB) whose job is to protect participants, and care is overseen by licensed medical staff. You'll be told the known risks before you agree to anything, and you can stop at any time.
Will I get a placebo instead of the real treatment?+
Some studies compare a treatment against a placebo (an inactive version), and some don't. If this one does, the study team will explain your chances of receiving the active treatment before you decide. Nothing is hidden from you.
Do I have to stop taking my current medications?+
It depends on the study. Some let you stay on your current medications and some ask you to adjust them. Never stop a medication on your own — the study team will review everything with you first.
Does it cost anything? Will I be paid?+
The study treatment and study-related visits are provided at no cost to you. Some studies also pay for your time; the coordinator can tell you if this one does. You should never be asked to pay to take part.
Do I need insurance? Will anyone ask about my immigration status?+
No. You do not need health insurance to take part in a research study, and you will not be asked about your immigration status to join. Taking part is about whether you're a medical fit for the study.
What if English isn't my first language?+
You have the right to understand everything before you agree. Study sites can often provide materials or an interpreter in your language — you can ask the coordinator for one.
Is my information private?+
Yes. Your health information is only shared with the study sites you choose to be contacted by, and only to help match and enroll you. It is never sold, and you can ask us to delete it at any time.
Source: ClinicalTrials.gov · NCT07226661 · Locations: California