RecruitingMajor Depressive Disorder
Regulated Stimulation for Optimized Network Activity and Therapeutic Equilibrium
Eligible age
22–85 yrs
Accepts
All genders
Locations
3 states
Healthy volunteers
No
See if you qualify for this study
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About this study
The objective of this study is to evaluate the safety, tolerability, and preliminary efficacy of the Motif eXternally powered Cortical Stimulation (XCS) System when used as indicated for treatment-resistant depression (TRD).
Sponsor: Motif Neurotech, Inc.
You may qualify if…
- ✓ 1. 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)
- ✓ 2. Has a screening Montgomery-Åsberg Depression Rating Scale (MADRS) score of ≥20
- ✓ 3. 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 Antidepressant Treatment History Form (ATHF)
- ✓ 4. Is willing and able to provide written informed consent
- ✓ 5. Is 22-85 years of age
- ✓ 6. Is willing and able to comply with the protocol, including follow-up visits
- ✓ 7. 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
You may not qualify if…
- ✕ 1. Has a cranial implant (with the exception of dental implants), neurostimulator, implanted medication pump, spinal cord stimulator, or pacemaker/implantable cardioverter-defibrillator
- ✕ 2. Has knowledge of planned magnetic resonance imaging (MRIs) in the next 12 months, after implant
- ✕ 3. Is unable to undergo imaging with computed tomography (CT), magnetic resonance imaging (MRI), diffusion tensor imaging (DTI), or functional magnetic resonance imaging (fMRI)
- ✕ 4. In the opinion of the investigator, the implant and therapy pose an unacceptable surgical or medical risk to the patient
- ✕ 5. Is currently taking blood thinners and cannot be taken off blood thinners
- ✕ 6. 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
- ✕ 7. 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 visit
- ✕ 8. Has a history of bipolar disorder
Where it's recruiting
Source: ClinicalTrials.gov · NCT07594483 · last updated 2026-10-21