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 | √**** | √ | √ |