DBS of the Lateral Habenula in Treatment-Resistant Depression

Prior treatment

• Participation in another drug, device, or biological trial within 30 days;
• Unable to maintain a stable psychotropic medication regimen in the next 24 months

Other illness

• Schizophrenia Spectrum or Other Psychotic Disorders (excluding Schizotypal (Personality) Disorder and Substance/Medication Induced Psychotic Disorder); presence of primary or serious (requiring additional treatment) disorders: comorbid obsessive compulsive disorder, post-traumatic stress disorder, panic disorder, bulimia or anorexia, in the last year;
• Cluster A or B personality disorder;
• Neurological disease that impairs motor, sensory or cognitive function or that requires intermittent or chronic medication (e.g., Parkinson's disease, MS, stroke);
• Any history of seizure disorder or hemorrhagic stroke;
• Any medical contraindication to surgery, including infection or coagulopathy;
• Current implanted stimulation devices including cardiac pacemakers, defibrillators, and neurostimulators including spinal cord stimulators, and deep brain stimulators;

Other

• Alcohol or substance abuse/dependence within 6 months, excluding nicotine and cannabis provided that participant either a) has a legal prescription or b) is a legal resident of a state where recreational cannabis use is legal;
• Current substantial suicidal risk as defined by a plan or clear immediate intent for self-harm, or had a serious suicide attempt within the last year;
• Does not have adequate family/friend support as determined by psychological screening and/or interview;
• Abnormal brain MRI;
• Pregnant or has plans to become pregnant in the next 24 months.

• Men and women (non-pregnant) between ages 21 and 70;
• DSM-5 diagnosis (assessed by Structured Clinical Interview for DSM-5, SCID-5) of a current major depressive episode (MDE), recurrent or single episode with first episode before age 45, secondary to either nonpsychotic unipolar major depressive disorder (MDD)or bipolar disorder (BD) I;
• Chronic illness with current MDE ≥ 24 months duration and/or recurrent illness with at least a total of 4 lifetime episodes (including current episode ≥ 12 months);
• For subjects with a bipolar disorder: the last manic or hypomanic episode must have been ≥ 24 months before study enrollment and patients must be maintained on a mood stabilizer (e.g. lithium or another mood stabilizer approved for bipolar disorder).
• Treatment resistance (defined by criteria on the Antidepressant Treatment History Form): Failure (i.e. persistence of the major depressive episode) to respond to a minimum of three adequate depression treatments from at least two different treatment categories (e.g. SSRI's, TCA's, other antidepressants, lithium-addition, irreversible MAO-inhibitor, antidepressant augmentation with an atypical antipsychotic medication); also, if diagnosed as bipolar, failure to respond to (or inability to tolerate) a minimum of three treatments approved for bipolar disorder, including lithium and at least one medication FDA-approved for bipolar depression (e.g., olanzapine/fluoxetine combination, quetiapine, lurasidone).
• Previous trial of ECT (lifetime)
• Symptom Severity: HDRS17 ≥ 21; on two separate assessments (at initial screening and 1 week before surgery), over a 1-month period;
• Normal brain MRI within 3 months of surgery;
• Stable antidepressant medical regimen for the month preceding surgery
• Modified mini-mental state examination (MMSE) score ≥ 27;
• Normal thyroid stimulating hormone (TSH) level within 12 months of study entry;
• Other medical conditions must be stable for at least 1 year;
• Anticipates a stable psychotropic medication regimen in the next 24 months;
• Subject must be able to identify a family member, physician, or friend who will participate in the Treatment Contract;
• Able and willing to give informed consent.