DBS for Depression (NCT06096207) | Clinical Trial Compass
RecruitingPhase 1
DBS for Depression
United States20 participantsStarted 2023-10-18
Plain-language summary
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 can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Major Depression Disorder (MDD) or Bipolar Disorder (I /II) diagnosed by Structured Clinical Interview for DSM-V (SCID I/DSM-V)
. Age 18 - 65 years.
. 24-item Hamilton Depression Rating Scale (HDRS) score of at least 21 on the first 17 items and/or Montgomery-Asburg Depression Rating Scale (MADRS) score of at least 21.
. World Health Organization Disability Assessment Scale 2.0(WHODAS2.0) score of 19 or more
. A recurrent (equal or \>4 episodes) or chronic (episode duration equal or higher \>2 years) course AND a minimum of 5 years since the onset of the first depressive episode. Major impairment in functioning or potentially severe medical outcomes (repeated hospitalizations, serious suicidal or other self-injurious behavior) over lifetime history as determined by an investigator
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. As determined by the study psychiatrist/investigator, has treatment resistant depression defined as failure to respond to: 6.1. Adequate trials (equal or \>6 weeks at an adequate dose) of primary antidepressants from at least 3 different classes AND; 6.2. adequate trials (equal\>4 weeks at an adequate dose) of augmentation/combination of a primary antidepressant using at least 2 different augmenting/combination agents (lithium, T3, stimulants,neuroleptics, anticonvulsants, buspirone, or a second primary antidepressant) AND; 6.3 An adequate trial of ECT (\>6 bilateral treatments), or inability to tolerate an adequate ECT trial, AND; 6.4 An adequate trial of individual psychotherapy (\>20 sessions with an experienced psychotherapist).
. Able to comply with the operational and administrative requirements of participation in the study.
. Able to give written informed consent
Exclusion criteria
. Patients with any lifetime history of psychosis or psychotic disorder, according to DSM-V diagnostic criteria, or in the medical opinion of the PI/study psychiatrist.
. Any finding on the preoperative magnetic resonance imaging (MRI) scan that, in the opinion of the principal investigator and after consultation with the neuroradiologist, is, or might be, considered clinically significant such that participation in the study: (a) seems likely to increase the medical risk to the subject sufficient to outweigh the potential benefit to study participation; (b) seems likely to jeopardize the subject's ability to complete the study or fulfill all study requirements per protocol; or (c) may impact he integrity of the data or the validity of the results.
. Any previous surgery to destroy the treatment target (superolateral MFB) rendering it either unilaterally or bilaterally damaged such that it cannot be effectively stimulated, as visualized by pre-operative MRI scans, in the medical opinion of the PI
. Any surgical contraindications to undergoing DBS, including labeled contraindications for DBS and/orinability to undergo presurgical MRI (cardiac pacemaker, implantable defibrillator or other implantablestimulator, pregnancy, metal in body, severe claustrophobia), infection, coagulopathy, inability to undergo an awake operation, significant cardiac or other medical risk factors for surgery. DBS contraindications include patients who are unable to properly operate the neurostimulator, and patientswho will be exposed to MRI or diathermy. MRI and diathermy (e.g., shortwave diathermy, microwave diathermy or therapeutic ultrasound diathermy) are contraindicated because the energy can be transferred through the implanted System (or any of the separate implanted components), which can cause tissue damage and can result in severe injury or death. Diathermy can damage parts of the neurostimulation system.
. Refusal of an adequate trial of ECT in the medical opinion of the study psychiatrist or PI following consultation with a study psychiatrist.
. History of stimulation intolerance in any area of the body.
. Within six (6) months of the enrollment date, has been diagnosed with, or has met the diagnostic criteria for, a substance abuse disorder (SUD) according to DSM-V criteria.
. Women of childbearing potential who, at enrollment or during the study: (a)have a positive urine pregnancy test; (b) are heterosexually active without the usage of a medically acceptable, highly effect contraceptive method\* (≤1% pregnancy rate); or (c) are planning to become pregnant during the 60-month course of this study, as determined by the PI. \*Examples include tubal ligation, vasectomized partner, IUD or IUS (intrauterine device or system), and long-acting reversible contraceptives (LARC).