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New treatment option for Major Depressive Disorder
Official title DBS for TRD With the Medtronic Percept PC
ClinicalTrials.gov ID: NCT05773755
What this study is testing
- What it's testing
- Of the estimated 30 million Americans who suffer from Major Depressive Disorder, approximately 10% are considered treatment resistant. Deep brain stimulation (DBS) to a region of the brain called the subcallosal cingulate (SCC) is an emerging strategy for treatment resistant depression (TRD), which involves placement of electrodes in a specific region of the brain and stimulating that area with electricity.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 25 to 70
You may be able to join if
- Age 25-70 years old.
- Ability to provide written informed consent.
- Primary psychiatric diagnosis of Major Depressive Disorder (MDD), either single episode or recurrent type, without psychotic features, currently...
- Current depressive episode of at least two years duration OR a history of more than 3 lifetime depressive episodes.
- Minimum score at study entry of 20 on the 17-item Hamilton Depression Rating Scale
You likely can't join if
- Other primary Axis I conditions
- Active suicidal ideation with intent, suicide attempt within the last six months, more than three suicide attempts within the last two years, or...
- Other primary neurological disorders or unstable medical illness
- Conditions requiring anticoagulant therapy which cannot be discontinued for the perioperative period, as required
- Pregnancy or plan to come pregnant during the study
- Contraindications for general anesthesia, neurosurgery, or an MRI scan
See the full eligibility criteria
- Age 25-70 years old.
- Ability to provide written informed consent.
- 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...
- Current depressive episode of at least two years duration OR a history of more than 3 lifetime depressive episodes.
- Minimum score at study entry of 20 on the 17-item Hamilton Depression Rating Scale
- Average pre-operative HDRS-17 score of 20 or greater (averaged over four weekly pre-surgical evaluations during the four weeks prior to surgery)
- A maximum Global Assessment of Functioning of 50 or less.
- Confirmed to have treatment-resistant depression (TRD). Treatment-resistance will be defined as failure to respond to at least four adequate antidepressant treatments (assessed with the Antidepressant Treatment History...
- ability comply with study and device management procedures.
- Other primary Axis I conditions
- Active suicidal ideation with intent, suicide attempt within the last six months, more than three suicide attempts within the last two years, or serious suicide risk as determined by the study psychiatrists
- Other primary neurological disorders or unstable medical illness
- Conditions requiring anticoagulant therapy which cannot be discontinued for the perioperative period, as required
- Pregnancy or plan to come pregnant during the study
- Contraindications for general anesthesia, neurosurgery, or an MRI scan
- Currently implanted with a cardiac pacemaker / defibrillator or other implanted electrical device which may interfere with DBS stimulator or the function of which may be impacted by its implantation.
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 25 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.