Major Depressive Disorder study: Motif XCS System
Official title Regulated Stimulation for Optimized Network Activity and Therapeutic Equilibrium
ClinicalTrials.gov ID: NCT07594483
What this study is testing
- What it's testing
- The objective of this study is to look at the safety, side effects, and preliminary how well it works of the Motif eXternally powered Cortical Stimulation (XCS) System when used as indicated for treatment-resistant depression (TRD).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 to 85
You may be able to join if
- Has a diagnosis of unipolar non-psychotic Major Depressive Disorder (MDD) and is currently experiencing a major depressive episode (MDE) as defined...
- Has a screening Montgomery-Åsberg Depression Rating Scale (MADRS) score of ≥20
- Has not had a sustained response to 2 or more adequately dosed antidepressant treatments from at least 2 different antidepressant treatment classes...
- Is willing and able to provide written informed consent
- Is 22-85 years of age
You likely can't join if
- Has a cranial implant (with the exception of dental implants), neurostimulator, implanted medication pump, spinal cord stimulator, or...
- Has knowledge of planned magnetic resonance imaging (MRIs) in the next 12 months, after implant
- Is unable to undergo imaging with computed tomography (CT), magnetic resonance imaging (MRI), diffusion tensor imaging (DTI), or functional magnetic...
- In the opinion of the investigator, the implant and therapy pose an unacceptable surgical or medical risk to the patient
- Is currently taking blood thinners and cannot be taken off blood thinners
- Has taken ketamine or esketamine in the past 30 days or is planning on taking ketamine or esketamine before the 4-week follow-up visit
See the full eligibility criteria
Who can join
- Has a diagnosis of unipolar non-psychotic Major Depressive Disorder (MDD) and is currently experiencing a major depressive episode (MDE) as defined by Diagnostic and Statistical Manual of Mental Disorders (DSM-5)
- Has a screening Montgomery-Åsberg Depression Rating Scale (MADRS) score of ≥20
- Has not had a sustained response to 2 or more adequately dosed antidepressant treatments from at least 2 different antidepressant treatment classes in at least one episode of major depressive disorder, according to the...
- Is willing and able to provide written informed consent
- Is 22-85 years of age
- Is willing and able to comply with the protocol, including follow-up visits
- Has been on a stable psychiatric treatment regimen for 30 days before the study screening MADRS and is willing to maintain a stable psychiatric treatment regimen through the Week 4 follow-up visit
What rules you out
- Has a cranial implant (with the exception of dental implants), neurostimulator, implanted medication pump, spinal cord stimulator, or pacemaker/implantable cardioverter-defibrillator
- Has knowledge of planned magnetic resonance imaging (MRIs) in the next 12 months, after implant
- Is unable to undergo imaging with computed tomography (CT), magnetic resonance imaging (MRI), diffusion tensor imaging (DTI), or functional magnetic resonance imaging (fMRI)
- In the opinion of the investigator, the implant and therapy pose an unacceptable surgical or medical risk to the patient
- Is currently taking blood thinners and cannot be taken off blood thinners
- Has taken ketamine or esketamine in the past 30 days or is planning on taking ketamine or esketamine before the 4-week follow-up visit
- Has taken hallucinogenic or dissociative medications in the past 30 days or is planning on taking hallucinogenic or dissociative medications for the treatment of mood or anxiety disorders before the 4-week follow-up...
- Has a history of bipolar disorder
- Has a history of schizophrenia, schizoaffective disorder, or other psychotic disorder
- Has psychotic features in the current depressive episode
- Has a chronic and clinically significant neurological disorder (epilepsy, dementia, delirium, amnestic disorder, brain tumor), or neuroimaging findings that would potentially impact the how well it works of treatment...
- Currently taking medication that would alter the seizure threshold, increasing potential seizure risks
- Has a history of brain injury that resulted in current cognitive impairment
- Has a history of bony disorders that impact the safe and effective use of the device as well as device implantation
- Has a history of skin disorders that impact the safe and effective use of the device as well as device implantation
- Has failed all attempts to achieve at least 50% reduction in depressive symptoms after completion of approved treatment courses of electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) for treatment...
- Is planning to receive any other neuromodulation therapy during the study
- Meets the DSM-5 criteria for alcohol use disorder or other substance use disorder (not including tobacco/nicotine) within 12 months prior to study enrollment or, in the opinion of the investigator, is using illicit...
- Female who is pregnant at the time of inclusion, or planning to become pregnant during the duration of the study, or not willing to use an effective method of birth control
- Has a life expectancy less than 12 months
- In the opinion of the investigator, is considered to be acutely suicidal (e.g., Type 4 or 5 on the Columbia-Suicide Severity Rating Scale [C-SSRS])
- Psychiatric treatment regimen has remained stable
- Has skull thickness ≥5.5 mm and ≤15.5 mm over the implant target
The study team makes the final eligibility decision.
Where it is enrolling
- Atlanta, Georgia, United States
- Iowa City, Iowa, United States
- Houston, Texas, 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, but 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, 22 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Atlanta, Georgia, United States; Iowa City, Iowa, United States; Houston, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.