Age and diagnosis: Individual is 18 years or older with a confirmed diagnosis of severe treatment-resistant major depressive disorder (single or recurrent episode).age >=18
Prior pharmacotherapy failure: Inadequate response to pharmacotherapy despite antidepressant trials with two or more classes with adequate dose and duration, or documented adherence, or inability to tolerate two trials with documented side effects; details of trials (dates, maximum dose, duration, outcome, side-effects, adherence) must be provided on the form.>=2 classes
Form includes fields to list medication trials with date, dose, duration, outcome, side-effects, adherence.
Device and protocol documentation: Planned treatment documented as TMS or theta burst stimulation (TBS) with treatment parameters specified (HF-rTMS or LF-rTMS frequency) and indication whether an FDA-approved device will be used; if FDA-approved device marked, device must be specified.device specified
Form asks to specify device if FDA-approved.
Treatment course limits: Standard initial course will not exceed five sessions per week for six weeks (total of approximately 30 sessions), followed by a taper as indicated; requested number of sessions and start date must be provided.<=30 sessions initial
Form states standard course = five/week for six weeks (total of 30 sessions) and requests number of sessions/units and start date.
Safety screening: No implanted magnetic-sensitive medical device or metal within <=30 centimeters of the TMS magnetic coil unless disclosed and reviewed; specific devices (cochlear implant, ICD, pacemaker, VNS, DBS, metal aneurysm clips/coils/staples/stents) must be indicated if present (dental amalgam fillings acceptable).distance >30 cm or listed and reviewed
Form asks whether such devices are present and lists device types that must be reported.
Treatment context flags: Form documents whether request is for maintenance treatment, continuation treatment, or an acute episode; whether patient received TMS in the past 30 days and prior response to TMS (including standardized rating scale initial and final scores with dates).
Definition of prior response: >=50% reduction on a standardized rating scale and recurrence as clinically meaningful worsening; form captures initial and final scores and dates.