Table 1 Schedule of enrolment, assessments and interventions
Phase 1: ECT patients and healthy controls | Phase 2: ECT responders randomised to ketamine or midazolam | ||||||
|---|---|---|---|---|---|---|---|
Assessment | Baseline (pre-ECT) | Weekly during ECT course | End of ECT course | Pre-infusions | Infusions 1–4; weeks 1–4 | Follow-ups: weeks 6, 8, 12 and 20 | Final follow-up week 26 |
Diagnosis and treatment | |||||||
 Background, SCID, NART, CTQ | ✓ | ||||||
 Treatment review | ✓ | ✓ | ✓ (1–4) | ✓ (6–20) | ✓ | ||
Clinical outcomes | |||||||
 HDRS-24 | ✓ | ✓ | ✓ | ✓✓✓✓ (1–4) | ✓ (6–20) | ✓ | |
 QIDS-SR | ✓ | ✓ | ✓ | ✓✓✓✓ (1–4) | ✓ (6–20) | ✓ | |
Cognitive outcomes | |||||||
 ACE-R | ✓ | ✓ | ✓4th | ✓ | |||
 Digit spans | ✓ | ✓ | ✓4th | ✓ | |||
 Trails A + B | ✓ | ✓ | ✓4th | ✓ | |||
 sMMSE | ✓ | ✓ | ✓4th | ✓ | |||
 AMI | ✓ | ✓ | ✓4th | ✓ | |||
Ketamine effects | |||||||
 CADSS | ✓✓✓✓ (1–4) | ||||||
 BPRS | ✓✓✓✓ (1–4) | ||||||
 YMRS | ✓✓✓✓ (1–4) | ||||||
 PRISE | ✓✓✓✓ (1–4) | ||||||
Consent | |||||||
Signed consent | ✓ | ✓ | |||||
Verbal assent | ✓ | ✓ | ✓ | ✓✓✓✓ (1–4) | ✓ (6–20) | ✓ | |
Eligibility | |||||||
Eligibility check | ✓ | ✓ | ✓ | ✓ | ✓✓✓✓ (1–4) | ✓ (6–20) | ✓ |
Randomisation | |||||||
Allocation | ✓ | ||||||