iTBS Study for Depression (Randomized)

This is an interventional treatment trial for Executive Dysfunction focused on measuring depression, executive dysfunction, transcranial magnetic stimulation, intermittent theta burst stimulation, neuromodulation, older adults, geriatrics Read More

Inclusion Criteria:

1. Age ≥ 60 - 85 years old
2. Diagnosis of major depressive disorder (MDD), single or recurrent, with a current Major depression episode as diagnosed by the Mini-international Neuropsychiatric Interview (MINI 6.0)
3. Montgomery Asberg Depression Scale score greater than or equal to 15 at baseline.
4. Evidence of decreased executive function as evidenced by either of the following conditions: a) scoring below the mean normative scaled score on the average of the NIH Toolbox executive function measures: Flanker inhibitory control and attention test and the Dimensional sort card test, approximate score 70 - 100 as per PI discretion. b) Discrepancy of at least 10 points between the average of the picture vocabulary score and the reading recognition test score and the average of the Flanker inhibitory control and dimensional card sort test score. c) Frontal Systems Behavior Scale (FRSBE) T scores above 60 (indicative of borderline to clinically significant impairment) and at least 10 points (1 Standard Deviation) above subject's premorbid (pre-depression) scores.

Exclusion Criteria:

1. Inability to complete NIH tool box cognitive testing
2. Inability to provide informed consent
3. <22 score on the Montreal Cognitive Assessment MoCA indicative of moderate to severe cognitive impairment per PI discretion
4. Lifetime diagnosis of bipolar I or II disorder or psychotic disorder as per the MINI interview
5. current psychotic symptoms
6. alcohol or other substance use disorder per DSM V criteria in the past 6 months
7. High risk for suicide (active suicidal ideation/intent or plan and patient is unsafe to be in the outpatient setting), an urgent psychiatric referral will be made in those cases
8. Have a diagnosis of obsessive compulsive disorder, post-traumatic stress disorder (current or within the last year), anxiety disorder (generalized anxiety disorder, social anxiety disorder, panic disorder), assessed by a study investigator to be primary
9. Previous history of TMS
10. history of failure to an adequate course of electroconvulsive therapy (ECT) such as equal or more than 7-9 electroconvulsive therapy treatments, per PI discretion
11. Major unstable medical illness including advanced/uncontrolled diabetes, hypertension, renal disease or advanced cancer, per PI discretion
12. Psychotropic use other than antidepressants (e.g., Benzodiazepines [more than 2mg of lorazepam equivalent daily], anticonvulsants [except low dose of Neurontin approximately 600mg/day] or cognitive enhancers such as N-Methyl D - Aspartate (NDMA) receptor antagonists [Memantine HCL], psychostimulants [such as methylphenidate or modafinil]) per PI discretion
13. Recent changes or initiation of antidepressant therapy approximately in the last 4 weeks prior to intervention delivery, per PI discretion
14. if participating in psychotherapy, must have been in stable treatment for at least 3 months prior to entry into the study, with no anticipation of change in the frequency of therapeutic sessions, or the therapeutic focus over the duration of the study
15. contraindications for TMS including the presence of metallic objects within 30 cm of the TMS coil, intracranial implants (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed; presence of intracardiac lines, defibrillators or a cardiac pacemaker and unable to assess safety; presence of implanted electronic devices that control physiologic functions and unable to assess safety
16. have a personal history of a primary seizure disorder or a seizure associated with an intracranial lesion
17. History of severe head trauma or neurological disorders that substantially increase seizure risk, per PI discretion
18. non-correctable clinically significant sensory impairment (i.e., cannot hear well enough to cooperate with interview).