Pilot Study of the Safety and Tolerability of L-DLPFC iTBS rTMS for MDD in MS

Participation Requirements

• Sex:

  ALL

• Eligible Ages:

  18 to 70

Participation Criteria

Inclusion criteria

1. Men and women ≥18 and ≤70 years of age, inclusive.
2. History of MS confirmed by a neurologist.
3. Patients who are able and willing to give consent and able to adhere to treatment schedule and attend study visits, as determined by study psychiatrist
4. DSM-V diagnosis of Major Depressive Disorder (MDD)
5. Moderate severity with a Hamilton Depression Rating Scale (HAMD) at least 16
6. Patients have had no increase or initiation of any psychotropic medication in the 4 weeks prior to screening
7. Pass the TMS safety screening questionnaire
8. Women of childbearing potential must agree to use a barrier contraception method throughout the study.

Exclusion criteria

1. Active substance abuse or dependence in the last three months, except nicotine
2. Active suicidal intent
3. Currently pregnant (as determined by history and serum HCG) or lactating.
4. A diagnosis of Bipolar Disorder
5. A history of past or current psychotic symptoms
6. Diagnosis of obsessive-compulsive disorder, post-traumatic stress disorder (current or within the last year), assessed by a study investigator to be primary and causing greater impairment than MDD
7. Having failed a course of ECT in the current episode or previous episode
8. Previous trial of rTMS
9. Personality disorder deemed to be primary pathology
10. 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
11. Clinically significant laboratory abnormality, in the opinion of the investigator
12. Unstable medical illness
13. Contraindication to rTMS, e.g. presence of cardiac pacemaker, intracranial implant, or metal in the cranium
14. Currently on more than 2 mg of lorazepam or equivalent
15. History of seizures, or currently on anticonvulsant for seizures
16. Concurrent use of a medication that may lower the seizure threshold, in the opinion of the investigator e.g. stimulant.