|STOP-PD II schedule of events: acute and stabilization phases and randomized controlled trial (RCT)|
|Instrument||Baseline||Acute phasea(week) (4-12 wks in duration)||Stabilization phase (week)||Discontinuation RCT (week)|
|Weight & Waist Circumference||x||x||x||x||x||x||x||x||x||x||x||x||x||x||x||x||x||x||x||x||x|
|Drug Plasma Levels||x||x||x||x||x|
|Quality of Lifei||x||x||x|
|Best Guess Formj||x|
a The duration of the Acute Phase is variable and can last between 4 and 12 weeks, depending on time to response.
b These assessments are completed at the end of the Acute Phase, which occurs between 4 and 12 weeks after starting study medications.
c These assessments are completed at week 36 or at the point of termination.
d Primary clinical ratings are HAM-D, DAS, SADS delusion and hallucination items, SSI, and CGI. In addition, the UKU side effects scale, Falls Log, and Concomitant Medication Log will be completed at these visits.
e Baseline physical includes physical examination, screening blood tests (CBC, electrolytes, creatinine, AST, ALT, TSH, Vitamin B12, pregnancy test for premenopausal women), urine drug screen, and EKG.
h Treatment resistance during the index episode of depression is measured with the Antidepressant Treatment History Form .
i The SF-36  will be administered to: i) examine the association of acute and remitted psychotic depression with participants’ health-related quality of life, and ii) explore the effect of continuation versus discontinuation of antipsychotic medication on participants’ health-related quality of life.
j The Best Guess Form is completed by participants at RCT termination, to determine, once the study is completed, whether they can guess treatment assignment on a greater than chance basis; this will serve as an indicator of how well the study’s double-blind was preserved.
Flint et al.
Flint et al. BMC Psychiatry 2013 13:38 doi:10.1186/1471-244X-13-38