| Eligibility |
Inclusion Criteria:
1. Outpatients with non-psychotic, unipolar Major Depressive Disorder (MDD) assessed via
the MINI structured interview
2. Must have been on a stable dose of antidepressant medication (excluding tricyclic
antidepressants) for at least 1 month prior to randomization, and with significant
residual MDD symptoms as evidenced by a HamD17 score > 17;
3. If receiving medication other than for depression (e.g., anxiety, sleep, mood
stabilization), must have been on stable dose for at least 1 month prior to
randomization
4. A history of treatment failure with at least one adequate trial of an antidepressant
medication in the current episode, assessed by the Antidepressant Treatment and
History Form
5. Age range: 22-65.
Exclusion Criteria:
1. Patient is mentally or legally incapacitated, unable to give informed consent.
2. Patients with psychosis (psychotic depression, schizophrenia, or schizoaffective
diagnoses (lifetime)); bipolar disorder (lifetime); dementia (lifetime); current Mini
Mental State Examination = 24; delirium or substance abuse within the past 6 months;
eating disorder within the past year; obsessive-compulsive disorder (lifetime);
post-traumatic stress disorder within the past year; acute risk for suicide or
self-injurious behavior. Patients with diagnostic uncertainty or ambiguity (e.g.
rule-out pseudodementia of depression) will be excluded.
3. Patients with a HamD suicidality item score of '3' or '4,' corresponding to "suicidal
ideas or gestures" or "attempts at suicide," will be excluded.
4. Patients with exposure to Electroconvulsive Therapy within the past 6 months, previous
TMS treatment for any condition, or Vagus Nerve Stimulation treatment (lifetime).
5. Patients who have met diagnostic criteria for any current substance abuse disorder at
any time in the 6 months prior to enrollment.
6. Past history of skull fracture; cranial surgery entering the calvarium; space
occupying intracranial lesion; stroke, Cerebral Vascular Accident, or Transient
Ischemic Attacks; cerebral aneurysm; Parkinson's or Huntington's disease; or Multiple
Sclerosis.
7. Any history of intracranial implant including cochlear implant, implanted
electrodes/stimulators, aneursym clips or coils, stents, bullet fragments; implanted
cardiac pacemaker, defibrillator, vagus nerve stimulator, deep brain stimulator; or
other implanted devices or objects contraindicated by product labeling.
8. Neurological conditions including epilepsy, cerebrovascular disease, dementia,
increased intracranial pressure, history of repetitive or severe head trauma, or with
primary or secondary tumors in the Central Nervous System.
9. current pregnancy, breast feeding, or not using a medically accepted means of
contraception.
10. Infection or loss of integrity of skin over the forehead, where the device will be
positioned.
11. Increased risk of seizure as indicated by: a) history (or family history) of seizure
or epilepsy; b) history of stroke, head injury, or unexplained seizures; c) concurrent
medication use such as tricyclic antidepressants, neuroleptic medications, or other
drugs that are known to lower the seizure threshold; d) secondary conditions that may
significantly alter electrolyte balance or lower seizure threshold; e) no quantifiable
motor threshold such that TMS dosage cannot be accurately determined.
12. Other medical contraindications to any of the study procedures.
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