Depression

DBS for Depression

Recruiting · Queens, New York

✓ PHASE1

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?

It is , overseen by an independent and licensed medical staff.

Read the full clinical description

The goal of this clinical trial is to demonstrate the feasibility and safety of deep brain stimulation in treatment resistant depression. The main questions it aims to answer are: * Is deep brain stimulation effective in treating treatment resistant depression? * Does deep brain stimulation improve overall clinical well-being and functioning? Participants will be implanted with a deep brain stimulation device. They will then be monitored over a 5-year period by using multiple questionnaires to track their depression symptoms. The device will be turned off at certain time points, unbeknown to the participant, to show the efficacy of the device when it is turned on. The device will be ON for 8.5 months and OFF for 3.5 months during the first year. Researchers will compare questionnaire scores when the device is off versus on to see if the device is working in reducing depression.

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…

•People age 18 to 65 with major depression (MDD) or bipolar disorder (type I or II).
•People with significant depression symptoms based on HDRS or MADRS score cutoffs in the study.
•People who have lasting or repeated depression over time and have had major trouble functioning or serious outcomes like repeated hospital stays or serious self-harm.
•People whose depression is considered “treatment resistant” after failing multiple antidepressant and add-on treatments, ECT, and psychotherapy, as described by the study.
•People who can follow study rules, attend regular mental health visits, and give written informed consent.

🚫 You may not be able to join if…

•People with any lifetime history of psychosis or a psychotic disorder.
•People with MRI results (before surgery) or other medical issues that make DBS unsafe, hard to complete, or likely to harm data quality.
•People who have had prior surgery that destroys the target area so it can’t be stimulated.
•People with DBS “contraindications,” including inability to undergo MRI/awake surgery, certain implanted devices (pacemaker/defibrillator/other implanted stimulator), metal in the body, severe claustrophobia, infection/coagulopathy, or inability to operate the neurostimulator; also those exposed to MRI or diathermy.
•People with recent substance abuse disorder (within 6 months), active suicidal thinking with intent, a recent suicide attempt, or high suicide risk as judged by the study team.

Are you a good fit?

Simplified highlights. The study team always confirms the full details with you.

✓Adults roughly 18–65
✓Have Depression

!Not for people who are pregnant or breastfeeding

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?

This is an early-stage study. The treatment has gone through laboratory and preliminary testing before being studied in people here.

What you need to know before you apply

What is this study testing?+

Is it safe? Who makes sure of that?+

This is an early study (Phase 1), focused mostly on safety. 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?+

Study-related care is 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.

Some requirements (like specific lab values or timing) are confirmed directly by the study team, not by us.

Source: ClinicalTrials.gov · NCT06096207 · Locations: New York