Consent Process:
After referral from the clinician, subjects will be contacted either by phone, by email,
or in person, advised of the opportunity to participate in this study, and informed about
what the study will entail. Subjects will give their own consent and will be over the age
of 18.
Study Procedures:
All procedures may be available to all participants. If the participant agrees to take
part in this study, the participant will be asked to undergo the following procedures
during the experimental visit.
Clinical Measurement Initiative (CMI) Data: As part of routine clinical care, patients
receiving TMS at McLean Hospital complete computerized clinician administered and patient
self-reported assessments of clinical symptoms on admission and at interim and discharge
points in their care. The computerized assessments are part of McLean Hospitals Clinical
Measurement Initiative (CMI), which uses Research Electronic Data Capture (REDCap)
software and a McLean-developed reporting module to generate individual patient reports
used in ongoing clinical care and patient outcomes monitoring. The CMI was implemented in
the McLean TMS program in May 2010. The investigators plan to conduct data analyses
examining changes in TMS patient self-report of symptoms on the following standardized,
validated surveys: Quick Inventory of Depressive Symptomatology Self Report (QIDS-SR) and
Patient Health Questionnaire-9 (PHQ-9), Generalized Anxiety Disorder-7 which will be
self-administered at treatment #1, #9, #14, #19, #24, #29, and #34, as well as
clinician-administered Clinical Global Impression-Severity (CGI-S) at the point of
consultation.
Transcranial Magnetic Stimulation (TMS): TMS involves a procedure where parts of the
participant's brain will be non-invasively (i.e. indirectly) stimulated by magnetic
pulses. Repetitive TMS (rTMS) administered in the study does not differ from standard of
care as practiced in the McLean Clinic. Therefore, all patients will receive standard of
care treatment combined along with either placebo or d-serine, designed to enhance
clinical benefits.
Visits:
All visits follow our normal clinical schedule:
Visit 1: Participants will first undergo a TMS consultation to determine eligibility to
safely receive TMS and assess clinical appropriateness for TMS.
Visit 2-37: 30 sessions of rTMS sessions (10-20 minutes long) daily, Mondays through
Fridays, excluding weekends and holidays.
Drugs to be used (dose, method, schedule of administration, dose modifications,
toxicities), include:
D-serine, 80 mg/kg (max 7g), oral administration, will be advised to be taken 1-hour
prior rTMS treatment day (Mon-Fri) for 6 weeks. Dosing is based on maximal plasticity at
80 mg/kg, and clinical dose-finding studies demonstrating that doses between 60 - 120
mg/kg were superior in clinical effectiveness to 30 mg/kg and were safe. The drug will
stopped at the discretion of the study clinicians after evaluation and assessment of any
signs of adverse effects or signs of clinical worsening.