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Table 1 Schedule of Events

From: Study protocol for a randomised placebo-controlled trial of pramipexole in addition to mood stabilisers for patients with treatment resistant bipolar depression (the PAX-BD study)

 

Screening

Pre-randomisation

Screening and Randomisation

0

Treatment weeks (Post-randomisation)

Tapering (5, 6, 7)

1

2

3

4

5

6

7

8

9 to 11

12

13 to 15

16

17 to 19

20

21 to 23

24

25 to 27

28

29 to 31

32

33 to 35

36

37 to 39

40

41 to 43

44

45 to 47

48

49 to 51

52*

Informed consent (1,2)

✓

 

✓

                               

Demographics

✓

✓

                                

Eligibility assessment

✓

 

✓

                               

Randomisation

  

✓

                               

RA safety monitoring call (3, 8)

 

✓

 

✓

✓

✓

✓

✓

✓

✓

✓

✓

✓

✓

 

✓

 

✓

 

✓

 

✓

 

✓

 

✓

 

✓

 

✓

 

✓

✓

✓

CSO contact (4)

     

✓

   

✓

   

✓

     

✓

     

✓

     

✓

 

✓

QIDS-SR, GAD-7 and ASRM

 

✓

 

✓

✓

✓

✓

✓

✓

✓

✓

✓

✓

✓

✓

✓

✓

✓

✓

✓

✓

✓

✓

✓

✓

✓

✓

✓

✓

✓

✓

✓

✓

✓

SHAPS

   

✓

     

✓

   

✓

                    

WSAS

   

✓

     

✓

   

✓

     

✓

     

✓

     

✓

  

TSQM

         

✓

   

✓

 

✓

 

✓

 

✓

 

✓

 

✓

 

✓

 

✓

 

✓

 

✓

  

QUIP-RS

   

✓

     

✓

   

✓

 

✓

 

✓

 

✓

 

✓

 

✓

 

✓

 

✓

 

✓

 

✓

 

✓

MADRS, QIDS-C and YMRS

   

✓

         

✓

                    

IMP Dispensings

  

✓

    

✓

     

✓

   

✓

   

✓

   

✓

   

✓

    

Qualitative Interviews

 

✓

           

✓

                    

Participant Vouchers

             

✓

           

✓

       

✓

Unblinding (9)

                               

✓

  
  1. [1]Consent is received to enter the pre-randomisation phase. 2 To be randomised to trial medication. 3 Weekly through pre-randomisation phase and until participant begins trial medication. 4 CSO or other delegated person at site – this will involve collection of medication returns and urine samples. 5 If a participant stops taking medication for any reason during the trial, RA phone calls including Dopamine Agonist Withdrawal Syndrome screening will take place weekly during tapering. If participant has withdrawn from the trial, final safety assessment including pregnancy test for women of child-bearing potential will take place when participant has been drug-free for 2 weeks. 6 Final safety assessments will take place at week 52 or when participant has been drug-free for 2 weeks, whichever is later. 7Week 49–52 schedule of assessments for tapering not applicable for participants who have been unblinded and are taking placebo. Participants receiving placebo will receive a final ‘thank you’ RA phone call following unblinding medication. No further safety assessments, including pregnancy test, will be undertaken for these participants. 8 Weekly through tapering phase. 9 Unblinding to take place after week 48 assessments only for participants who have indicated that they would wish to continue taking pramipexole after the end of the trial, if they were found to be receiving it. *Plus up to 2 weeks if required