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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.
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BMC Psychiatry

ISSN: 1471-244X

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