SC | Double-Blind Treatment Phase | Post | FU | FU | ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Week | 0 | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | EOT | 12 | 16 |
Administrative Forms | ||||||||||||
Informed Consent | ||||||||||||
Inclusion/Exclusion Review | X | |||||||||||
Locator Form and Updates* | X | X | X | X | X | X | X | X | X | X | X | |
Daily TMS Treatment Log | X | X | X | X | X | X | X | X | ||||
End of Treatment Form | X | |||||||||||
Study Completion | X | |||||||||||
General Assessments | ||||||||||||
Phen-X Toolkit Core Tier 1 | X | |||||||||||
Phen-X Toolkit Quality of Life | X | X | X | X | ||||||||
Study Demographics Form* | X | |||||||||||
Treatment/Study Satisfaction Form | X | X | ||||||||||
Medical Assessments | ||||||||||||
Physical Exam | X | |||||||||||
Medical and Psychiatric History | X | |||||||||||
Weight, Blood Pressure, and Pulse | X | X | X | X | X | X | ||||||
Adverse Events, Serious Adverse Events, and Medical Review | X | X | X | X | X | X | X | X | X | X | X | X |
Prior/Concomitant Meds | X | X | X | X | X | X | X | X | X | X | X | X |
Penetration of Blind Assessment | X | X | X | |||||||||
EEG | X | X | ||||||||||
Psychological Assessments | ||||||||||||
MINI 7.0.2* | X | |||||||||||
HADS | X | X | X | X | X | X | ||||||
Pittsburgh Sleep Quality Index | X | X | X | X | X | |||||||
CHRT-SR Suicidal Behavior Eval | X | X | X | X | X | X | X | X | X | X | X | X |
Substance Use Self Report | ||||||||||||
TLFB/Substance Use Diary | X | X | X | X | X | X | X | X | X | X | X | X |
Caffeine Consumption Assessment | X | X | X | X | X | X | X | X | X | |||
DSM-5 SUD Symptom Checklist* | X | |||||||||||
NIDA Marijuana Use Assessment | X | |||||||||||
Fagerström Test for Nicotine Dependence | X | X | X | X | X | |||||||
Daily Assessments | ||||||||||||
Visual Analog Craving Scale | X | X | X | X | X | X | X | X | X | X | X | X |
Report of Methamphetamine and/or Cocaine Use | X | X | X | X | X | X | X | X | X | X | X | X |
Report of Nicotine Use | X | X | X | X | X | X | X | X | X | X | X | X |
Mood | X | X | X | X | X | X | X | X | X | X | X | X |
Sleep | X | X | X | X | X | X | X | X | X | X | X | X |
Actigraphy | X | X | X | X | X | X | X | X | X | |||
Lab Testing | ||||||||||||
UDS (dipstick)* | X | X | X | X | X | X | X | X | X | X | X | X |
Urine Pregnancy Test* | X | X | X |