← Back to Search

Procedure

Deep Brain Stimulation for Treatment-Resistant Depression

N/A
Recruiting
Research Sponsored by Helen Mayberg, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 25-70 years old
Primary psychiatric diagnosis of Major Depressive Disorder (MDD), either single episode or recurrent type, without psychotic features, currently experiencing a Major Depressive Episode (MDE), as diagnosed by Structured Clinical Interview for DSM IV-TR or DSM-5 (SCID-IV or SCID-5). Two independent psychiatrists will confirm the diagnosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and up to 1 year
Awards & highlights

Study Summary

This trial aims to find biomarkers to guide placement and select stimulation parameters of a DBS device to help people with treatment-resistant depression. Participants will complete questionnaires and collect data twice daily for up to one year.

Who is the study for?
This trial is for adults aged 25-70 living in the New York area with Major Depressive Disorder (MDD) that hasn't improved after trying at least four different treatments. They should be experiencing a severe depressive episode lasting two years or have had more than three episodes. Participants must be able to follow study procedures and give written consent.Check my eligibility
What is being tested?
The trial tests Deep Brain Stimulation (DBS) using the Medtronic Percept PC system on patients with treatment-resistant depression. It involves placing electrodes in the brain and stimulating it to potentially alleviate symptoms. The study also aims to identify biomarkers related to DBS effectiveness.See study design
What are the potential side effects?
Potential side effects may include discomfort from surgery, risk of infection, headache, confusion, speech problems, and changes in mood or behavior due to brain stimulation. Side effects can vary based on individual responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 25 and 70 years old.
Select...
I have been diagnosed with Major Depressive Disorder without psychosis.
Select...
I have been depressed for at least 2 years or had more than 3 depressive episodes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Hamilton Depression Rating Scale (HDRS) score
Secondary outcome measures
Change in Montgomery-Asberg Depression Rating Scale (MADRS)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Deep Brain Stimulation (DBS) for Treatment Resistant DepressionExperimental Treatment1 Intervention
Open label active Deep Brain Stimulation (DBS)

Find a Location

Who is running the clinical trial?

Helen Mayberg, MDLead Sponsor
1 Previous Clinical Trials
10 Total Patients Enrolled

Media Library

Medtronic Percept PC DBS system (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05773755 — N/A
Major Depressive Disorder Research Study Groups: Deep Brain Stimulation (DBS) for Treatment Resistant Depression
Major Depressive Disorder Clinical Trial 2023: Medtronic Percept PC DBS system Highlights & Side Effects. Trial Name: NCT05773755 — N/A
Medtronic Percept PC DBS system (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05773755 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals aged 45+ able to join this medical research?

"This medical study necessitates that participants are aged 25 or over, but not more than 70 years old."

Answered by AI

What are the eligibility criteria for participation in this research initiative?

"Participation in this study is restricted to individuals aged 25 - 70 that are diagnosed with major depressive disorder. A maximum of 10 patients are being accepted into the trial."

Answered by AI

How many participants has this research project attracted?

"Affirmative, according to clinicaltrials.gov's information this medical trial is still in search of participants. The project was launched on March 1st 2023 and had its most recent update on the 6th of that same month. 10 individuals need to be recruited across a single site."

Answered by AI

Are there openings for prospective participants in this clinical experiment?

"Affirmative. Clinicaltrials.gov confirms that, initially posted on March 1st 2023, this clinical trial is actively seeking applicants. Ten patients are needed and there is one location where recruitment will take place."

Answered by AI

Who else is applying?

What site did they apply to?
Icahn School of Medicine at Mount Sinai, Mount Sinai West
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
3+
Recent research and studies
~7 spots leftby Dec 2028