Clinical Trials

Inclusion Criteria:

• Subject must provide written informed consent prior to any clinical investigation-related procedure.
• Age 22-70 years old 3. Current MDE secondary to non-psychotic unipolar MDD, according to DSM-5 criteria, diagnostic interview and confirmed by 2 psychiatrists.
• Current MDE at least 12-months duration OR a history of more than 3 lifetime depressive episodes:
  • If a history of more than 3 lifetime depressive episodes, the current episode must be at least 3 months in duration.
• If current MDE is 12 or more months in duration:
  • Failure to respond or maintain response to a minimum of 4 different antidepressant treatments during current episode, including at least 3 medications from at least 3 different classes, evidence-based psychotherapy, TMS, esketamine, or ECT administered at adequate doses and duration (adequately defined by the Antidepressant Treatment History Form (ATHF-short form)), assessed by patient’s antidepressant history.
• If a history of more than 3 lifetime depressive episodes and current episode is 3 or more months in duration:
  • Failure to respond or maintain response to at least one antidepressant medication trial, OR a failed course of TMS or ECT during current episode.
  • AND lifetime failure to respond or maintain response to a minimum of three adequate depression treatments.
• Mini-mental state examination (MMSE) score > 24.
• MADRS of > 22 at 3 separate baseline visits, rated by 2 separate trained raters; Score differences between MADRS scores cannot exceed 25%.
• All patients must have an established outpatient psychiatrist and be willing to transfer care to the study investigators for the duration of the blinded analysis period. Subjects must also sign a written release to allow study investigators to give and receive information from the outpatient psychiatrist.
• Females of child-bearing potential who are heterosexually active, or may become heterosexually active during study participation, who agree to use a FDA- or CDC-approved method of birth control with > 90% effectiveness with typical use. The latter include: (a) sterilization surgery for women (> 99%); (b) sterilization surgery for men (> 99%); (c) IUD (>99%); (d) Implantable Rod (> 99%); (e) Contraceptive Shot/Injection (> 94%) (f) Oral Contraceptives (Combined pill, Progestin Only; Extended/Continuous Use) (> 91%); (g) Patch (estrogen and progestin); and (h) Vaginal Contraceptive Ring (> 91%). The form of birth control will be documented at screening and baseline, as per site standard practice.
• Able to comply with all testing and follow-up requirements as defined by the study protocol.
• In the opinion of the study neurosurgeon, the subject is medically stable and has no contraindications to the surgical requirements of the study.
• Able to give informed consent in accordance with institutional policies and local legislation.
• Depression medication and treatment regimen must be stable for a minimum of 4 weeks before the first baseline visit.

Exclusion Criteria:

• Subject is currently participating, or intends to participate, in another clinical investigation that may confound the results of this study, as determined by Abbott .
• Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period.
• Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator’s opinion, could limit the subject’s ability to participate in the clinical investigation or to comply with follow-up requirements of the clinical investigation. 4. Existing personality disorders or high likelihood of personality disorder presence that would significantly interfere with the subject’s participation in the study, as determined by clinical judgment and confirmed by centralized screening eligibility committee:
  • History of recurrent self-harm behaviors outside of a depressive episode, determined by clinical judgment.
• Current or lifetime history of psychotic features in any MDE.
• Has an intracranial Central Nervous System disease that impairs motor, sensory or cognitive function or that requires intermittent or chronic medication (e.g., Parkinson’s Disease, chronic migraine, stroke, Huntington’s, head trauma, etc.) with exception to non-migraine headaches.
• Significant acute suicide risk, defined as follows:
  • Suicide attempt that resulted in hospitalization within the twelve months prior to baseline;
  • Suicidal risk that, in the investigator’s opinion, requires inpatient treatment based on clinical judgment and history;
  • High suicide risk, as defined by Columbia Suicide Severity Rating Scale (C-SSRS) and clinician judgment.
• Terminal illness associated with an expected survival of < 12 months.
• Subject has a diagnosis of Substance Use Disorder or Alcohol Use Disorder as defined by DSM5 without sustained remission (12 months or longer)
• Has been diagnosed a current condition that requires chronic pain narcotic usage (e.g. morphine, methadone) which may confound the results of this study.
• Clinically relevant abnormality (e.g. tumor or growth) on study MRI (benign tumor stability is not an exclusion)
• Implanted devices that are contraindicated for MRI and/or any existing implants in the head or neck region that may make having an MRI unsafe.
• Current and ongoing use of neurostimulation treatment that may interfere with DBS therapy/system, such as vagus nerve stimulation (VNS), electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), or other electrical treatment.
• Conditions requiring diathermy.
• Current use of ketamine in any form and route of administration (intranasal, intravenous, intramuscular, oral)
• Known need for MRI post-implant.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 4/17/2024. Questions regarding updates should be directed to the study team contact.