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Table 2 STOP-PD II schedule of events: acute and stabilization phases and randomized controlled trial (RCT)

From: Sustaining remission of psychotic depression: rationale, design and methodology of STOP-PD ΙΙ

Instrument Baseline Acute phasea(week) (4-12 wks in duration) Stabilization phase (week) Discontinuation RCT (week)
   4 8 12b 4 8 1 2 3 4 5 6 7 8 12 16 20 24 28 32 36c
SCID x                     x
Clinical Ratingsd x x x x x x x x x x x x x x x x x x x x x
Weight & Waist Circumference x x x x x x x x x x x x x x x x x x x x x
Height x                     
Metabolic Labs x x   x   x         x   x   x   x x
Drug Plasma Levels   x   x   x           x      x
Genetic Testing x                     
Baseline Physicale x                     
Vital Signs x x x x x x x x x x x x x x x x x x x x x
Anxietyf x      x                
Medical Burdenf x      x                
Psychomotor Changef x      x                
Cognitiong x      x                
Treatment Resistanceh x                     
Quality of Lifei x      x                x
EPSE Ratings x x x x x x     x     x x x x x x x x
Best Guess Formj                      x
Pill Count   x x x x x x x x x x x x x x x x x x x x
  1. a The duration of the Acute Phase is variable and can last between 4 and 12 weeks, depending on time to response.
  2. b These assessments are completed at the end of the Acute Phase, which occurs between 4 and 12 weeks after starting study medications.
  3. c These assessments are completed at week 36 or at the point of termination.
  4. 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.
  5. 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.
  6. f Measures of anxiety, medical burden, and psychomotor change are the Hospital Anxiety and Depression Scale [37], Cumulative Illness Rating Scale [38], and CORE [39], respectively.
  7. g Cognitive evaluation includes: the IQCODE at baseline; and the MMSE, Immediate and Delayed Recall, Stroop, Trail Making, and Coding task [40, 41] at the end of the Stabilization Phase.
  8. h Treatment resistance during the index episode of depression is measured with the Antidepressant Treatment History Form [42].
  9. i The SF-36 [43] 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.
  10. 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.