Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder
Recruiting · 40 sites across 14 states
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 is a multicenter, randomized, double-blind, placebo-controlled parallel-group, fixed-dose study in patients with a primary diagnosis of MDD according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) who have an inadequate response to ongoing ADT.
It is , overseen by an independent and licensed medical staff.
Read the full clinical description
This is a multicenter, randomized, double-blind, placebo-controlled parallel-group, fixed-dose study in patients with a primary diagnosis of MDD according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) who have an inadequate response to ongoing ADT.
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 ages 18 to 65 (male or female).
- •Have major depressive disorder (MDD) confirmed using SCID-5-CT; MDD with psychotic features is allowed.
- •Current major depression episode started at least 12 weeks but not more than 18 months before screening.
- •Have moderate-to-severe depression at screening and baseline using MADRS, CGI-S, and QIDS-SR-16 scores.
- •Have had an inadequate response (less than 50% improvement) to 2 or more antidepressants for the current episode, and you are taking one at its minimum effective dose for at least 6 weeks.
🚫 You may not be able to join if…
- •Have a lifetime confirmed diagnosis other than MDD (including schizophrenia/other psychotic disorders, or bipolar disorder).
- •Have certain other psychiatric diagnoses close to screening (within 6 months), such as primary anxiety disorders (panic disorder or generalized anxiety disorder), OCD, or PTSD; eating disorders; substance use disorders (except nicotine); or personality disorders with major impact.
- •Have had another psychiatric condition other than MDD as the main focus of treatment within 12 months of screening.
- •Your depression improves too much before starting (≥25% decrease in MADRS from screening to baseline, and ≥25% decrease in QIDS-SR-16 from screening to baseline).
- •Have high risk for suicidal behavior during the study, including recent suicide attempts, or certain positive responses on suicide question items and severe suicidal thought ratings.
- •Your first major depressive episode started at age 60 or older.
Are you a good fit?
Simplified highlights. The study team always confirms the full details with you.
- ✓Adults roughly 18–65
- ✓Have Depression
- !Some conditions may not be a fit: 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 is a multicenter, randomized, double-blind, placebo-controlled parallel-group, fixed-dose study in patients with a primary diagnosis of MDD according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) who have an inadequate response to ongoing ADT.
Is it safe? Who makes sure of that?+
This is a late-stage study (Phase 3), testing how well the treatment works in more people. 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 · NCT05850689 · Locations: Alabama · California · Connecticut · Florida · Georgia · Kansas · Massachusetts · Missouri · New Jersey · New York · Ohio · Pennsylvania · Texas · Washington