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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.