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Table 1 Schedule of assessments and trial visits

From: The Study of Ketamine for Youth Depression (SKY-D): study protocol for a randomised controlled trial of low-dose ketamine for young people with major depressive disorder

Time point

Baseline

Treatment 1

24-h follow-up

Treatment 2

24-h follow-up

Treatment 3

24-h follow-up

Treatment 4

24-h follow-up

Week 4 follow up

Week 8 follow-up

Week 26 follow-up

Day

 − 21 to − 1

0

1

7

8

14

15

21

22

28a

56b

182c

 Informed consent

X

           

 Medical and psychiatric review

X

           

 Demographics

X

           

 Physical examination (vital signs)d

X

X

 

X

 

X

 

X

 

X

  

 Concomitant pharmaceutical treatment

X

X

 

X

 

X

 

X

 

X

X

X

 Medical condition

X

X

 

X

 

X

 

X

 

X

X

X

 Doctor’s provisional eligibility checkliste

X

           

 Final eligibility checklistf

X

           

Diagnosis

 SCID-5 (modules A, B/C Screen, and D)

X

           

Randomisationg

X

           

Intervention administeredh

ketamine vs midazolam

 

X

 

X

 

X

 

X

    

 Clinician prediction of treatment response

X

           

 Masking assessment

         

X

  

Biological measures

 Pregnancy (serum)i

X

           

 Clinical bloods

X

        

X

  

 Research bloodsj

X

Xk

       

X

  

Symptomatology

 Montgomery-Asberg Depression Rating Scale (MADRS)a

Xa

 

Xa

Xa

X

X

X

X

X

X

X

X

 Quick Inventory of Depression Symptomatology (QIDS)

X

  

X

 

X

 

X

 

X

X

 

 Clinical Global Impression-Severity Scale (CGI-S)

X

  

X

 

X

 

X

 

X

X

 

 Clinical Global Impression-Improvement Scale (CGI-I)

   

X

 

X

 

X

 

X

X

 

 Patient Global Impression-Improvement Scale (PGI-I)

   

X

 

X

 

X

 

X

  

 Generalized Anxiety Disorder 7-item Scale (GAD-7)

X

  

X

 

X

 

X

 

X

X

 

Suicidality

 Suicidal Ideation Screen (SIS)

X

  

X

 

X

 

X

 

X

X

 

 Columbia Suicide Severity Rating Scale (CSSRS)

X

  

X

 

X

 

X

 

X

X

 

Substance use

 Brief Substance Craving Scale (BSCS)

X

  

X

 

X

 

X

 

X

X

X

 Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)

X

        

X

X

X

Functioning/quality of life

 Assessment of Quality of Life (AQoL-8D)

X

        

X

X

 

 Social and Occupational Functioning Assessment Scale (SOFAS)

X

        

X

X

 

Sleep

 Actigraphyl

X

X

X

X

   

X

X

X

  

 Consensus Sleep Diary (CSD)m

X

X

X

X

   

X

X

X

  

 Pittsburgh Sleep Quality Inventory (PSQI)

X

        

X

X

 

 Revised Morningness-Eveningness Questionnaire (rMEQ)

X

           

Cognitive assessment

 Cogstate

X

        

X

  

Brain scan

 Magnetic resonance imaging (MRI)n

 

Xo

       

X

  

Drug and adverse effects

 Adverse events

X

X

X

X

X

X

X

X

X

X

X

X

 Ketamine Side-Effects Tool (KSET)p

X

X

 

X

 

X

 

X

 

X

X

X

 Clinician Administered Dissociative Symptoms Scale (CADSS)q

X

X

 

X

 

X

 

X

    

 Brief Psychiatric Rating Scale (BPRS)r

X

X

 

X

 

X

 

X

    

 Hood Mysticism Scale (HMS)s

 

X

          

 Drug Effects Questionnaire (DEQ)t

 

X

 

X

 

X

 

X

    
  1. aThe week 4/day 28 follow-up assessment will be completed within a window of ± 3 days of day 28. It will ideally be conducted face-to-face at the research site but may be conducted via a home visit or via telephone/telehealth video call if necessary
  2. bThe week 8/day 56 follow-up assessment will be completed within a window of ± 3 days of day 56. It will be conducted via telephone/telehealth video call
  3. cThe week 26/day 182 follow-up assessment will be completed within a window of ± 7 days of day 182. It will be conducted via telephone/telehealth video call
  4. dDuring treatment visits, vital signs will be assessed prior to treatment and four times after treatment (at 15, 30, 60, and 120 min). After the first treatment, vital signs will also be assessed at 240 min after treatment
  5. eTo be completed by a trial doctor after the Medical and Psychiatric Review on entry to the study
  6. fTo be completed once all data pertaining to eligibility has been finalised. Must not be completed earlier than day − 7
  7. gRandomisation can occur after the completion of the final eligibility checklist (which is to be finalised no earlier than day − 7) and up to and including day − 1
  8. hTreatment can be administered within ± 3 days of days 7, 14, and 21, respectively, with a minimum of 4 days between treatments. Missed sessions outside this window cannot be made up
  9. iPregnancy will be tested using serum at baseline. Participants will be re-tested during the treatment phase only if they indicate that there is a possibility that they may be pregnant
  10. jResearch blood samples are optional
  11. kResearch blood collected 4 h after first treatment
  12. lActigraphy is optional. For consenting participants, actigraphy will be collected for approximately 10–14 days, starting from approximately 3–7 days before the first treatment, until the second treatment visit (i.e. day 7). Actigraphy will be collected again over the 7 nights between the final treatment (day 21) and the week 4 follow-up (day 28)
  13. mThe Consensus Sleep Diary will be recorded for each night that actigraphy is collected, and only for those who consent to participate in the actigraphy assessment
  14. nThe MRI scans are optional
  15. oThe first MRI scan may be conducted during the baseline phase, or on the first treatment visit prior to the administration of medication
  16. pKSET screener and baseline administered at baseline; KSET acute treatment administered before and at 60 and 120 min after each treatment (plus at 240 min after the first treatment); KSET follow-up administered at weeks 4, 8, and 26 follow-up
  17. qAdministered at baseline and at 60 and 120 min after each treatment
  18. rAdministered at baseline and at 60 and 120 min after each treatment
  19. sAdministered 120 min after the first treatment
  20. tAdministered 60 min after each treatment
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Trials

ISSN: 1745-6215