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Table 2 Schedule of assessments

From: Study protocol for the randomised controlled trial: Antiglucocorticoid augmentation of anti-Depressants in Depression (The ADD Study)

 

Enrolment

Randomisation

Follow up

Time point

Week-2

Week 0

Week 1

Week 2

Week 3

Week 4

Week 5

Week 8

Week 16

Week 24

Assessment of eligibility

         

Informed Consent

         

Assessment of baseline characteristics – NewMood questionnaire*

         

Experimental Intervention

          

Assessment of depression severity – HDRS171

        

Assessment of Clinical symptoms – MADRS2, CAS3, BDI4,STAI5, YMRS6

 

  

 

Assessment of Quality of Life – EQ-5D

 

  

 

Assessment of side effects – TSES7

 

  

 

  

Assessment of side effects and adverse events – self report

 

Suicide risk assessment

 

 

Pregnancy Test if indicated

     

Assessment of concomitant medication

Measurement of HPA axis function (CAR plus 11 pm saliva sample)

 

  

 

   

Physical observations**

√***

 

   

   

Blood Tests – U&E’s, cortisol

√****

 

   

   
  1. * - See text under “Screening Visit” for description of NewMood questionnaire details.
  2. ** - Physical observations comprised sitting and standing pulse and blood, and pressure respiration rate.
  3. *** - Screening physical observations also included height and weight.
  4. **** – Screening blood tests also including thyroid function tests, liver function tests and full blood count.
  5. 1 HDRS17 Hamilton Depression Rating Scale – 17 item.
  6. 2 MADRS Montgomery-Asberg Depression Rating Scale.
  7. 3 CAS Clinical Anxiety Scale.
  8. 4 BDI Beck Depressive Inventory.
  9. 5 STAI State Trait Anxiety Inventory.
  10. 6 YMRS Young Mania Rating Scale.
  11. 7 TSES Toronto Side Effects Scale.