Table 4.
Efficacy outcomes in participants randomised to ketamine or saline
|
Ketamine group |
Saline group |
Treatment effect |
||||
|---|---|---|---|---|---|---|
| Mean score (SD) | n | Mean score (SD) | n | Estimated difference in slopes (95% CI) | p value | |
| MADRS | ||||||
| Baseline | 31·8 (7·4) | 33 | 35·2 (8·4) | 37 | .. | .. |
| Mid-ECT* | 25·4 (9·8) | 31 | 25·9 (12·4) | 33 | .. | .. |
| End of treatment | 17·2 (11·6) | 27 | 15·0 (10·4) | 32 | .. | .. |
| Ketamine vs saline from baseline up to end of treatment | .. | .. | .. | .. | −0·44 (−1·91 to 1·03) | 0·56 |
| 1-month follow-up | 16·8 (13·6) | 24 | 14·8 (11·4) | 23 | .. | .. |
| 4-month follow-up | 18·0 (13·3) | 19 | 13·5 (13·9) | 18 | .. | .. |
| CAS | ||||||
| Baseline | 7·79 (4·53) | 33 | 9·16 (5·23) | 37 | .. | .. |
| Mid-ECT* | 7·39 (5·29) | 31 | 7·48 (5·37) | 33 | .. | .. |
| End of treatment | 5·44 (4·04) | 27 | 5·16 (4·34) | 32 | .. | .. |
| Ketamine vs saline from baseline up to end of treatment | .. | .. | .. | .. | −0·02 (−0·42 to 0·38) | 0·93 |
| 1-month follow-up | 4·96 (4·62) | 24 | 4·43 (·89) | 23 | .. | .. |
| 4-month follow-up | 4·95 (4·73) | 19 | 3·67 (4·92) | 18 | .. | .. |
| BPRS | ||||||
| Baseline | 37·3 (5·4) | 33 | 40·0 (8·6) | 37 | .. | .. |
| Mid-ECT* | 35·1 (6·9) | 31 | 35·4 (8·5) | 33 | .. | .. |
| End of treatment | 29·6 (6·9) | 26 | 28·3 (6·1) | 32 | .. | .. |
| Ketamine vs saline from baseline up to end of treatment | .. | .. | .. | .. | −0·02 (−0·73 to 0·70) | 0·97 |
| 1-month follow-up | 28·8 (7·8) | 24 | 27·6 (6·4) | 23 | .. | .. |
| 4-month follow-up | 30·3 (8·3) | 19 | 27·1 (8·3) | 18 | .. | .. |
| CGI-Severity | ||||||
| Baseline | 5·03 (0·85) | 33 | 5·30 (0·97) | 37 | .. | .. |
| Mid-ECT* | 4·48 (1·12) | 31 | 4·24 (1·35) | 33 | .. | .. |
| End of treatment | 3·33 (1·33) | 27 | 2·88 (1·24) | 32 | .. | .. |
| Ketamine vs saline from baseline up to end of treatment | .. | .. | .. | .. | −0·03 (−0·18 to 0·13) | 0·73 |
| 1-month follow-up | 2·79 (1·56) | 24 | 2·57 (1·27) | 23 | .. | .. |
| 4-month follow-up | 3·00 (1·60) | 19 | 2·17 (1·34) | 18 | .. | .. |
| CGI-Improvement | ||||||
| Mid-ECT* | 3·03 (1·02) | 31 | 3·00 (1·09) | 33 | .. | .. |
| End of treatment | 2·52 (1·31) | 27 | 2·25 (1·11) | 32 | .. | .. |
| Ketamine vs saline from baseline up to end of treatment | .. | .. | .. | .. | 0·03 (−0·11 to 0·17) | 0·69 |
| 1-month follow-up | 2·13 (1·26) | 24 | 2·00 (1·04) | 23 | .. | .. |
| 4-month follow-up | 2·42 (1·35) | 19 | 2·11 (1·41) | 18 | .. | .. |
| QIDS-SR | ||||||
| Baseline | 17·9 (4·9) | 33 | 20·0 (3·9) | 37 | .. | .. |
| Mid-ECT* | 14·1 (5·6) | 31 | 16·0 (5·9) | 33 | .. | .. |
| End of treatment | 11·9 (6·2) | 27 | 11·0 (5·8) | 32 | .. | .. |
| Ketamine vs saline from baseline up to end of treatment | .. | .. | .. | .. | −0·30 (−0·88 to 0·29) | 0·32 |
| 1-month follow-up | 12·0 (7·5) | 24 | 10·1 (6·2) | 23 | .. | .. |
| 4-month follow-up | 12·5 (7·7) | 19 | 9·4 (7·5) | 18 | .. | .. |
| EQ-5D-3L index | ||||||
| Baseline | 0·35 (0·27) | 33 | 0·35 (0·28) | 37 | .. | .. |
| Mid-ECT* | 0·55 (0·28) | 31 | 0·44 (0·38) | 33 | .. | .. |
| End of treatment | 0·66 (0·26) | 27 | 0·70 (0·27) | 32 | .. | .. |
| Ketamine vs saline from baseline up to end of treatment | .. | .. | .. | .. | 0·01 (−0·01 to 0·03) | 0·43 |
| 1-month follow-up | 0·67 (0·33) | 24 | 0·71 (0·29) | 23 | .. | .. |
| 4-month follow-up | 0·60 (0·33) | 19 | 0·71 (0·34) | 18 | .. | .. |
| EQ-5D-3L VAS | ||||||
| Baseline | 31·9 (14·6) | 33 | 24·2 (16·9) | 37 | .. | .. |
| Mid-ECT* | 42·0 (18·6) | 31 | 33·6 (22·2) | 33 | .. | .. |
| End of treatment | 51·4 (22·3) | 26 | 52·2 (21·9) | 32 | .. | .. |
| Ketamine vs saline from baseline up to end of treatment | .. | .. | .. | .. | 1·16 (−1·09 to 3·41) | 0·31 |
| 1-month follow-up | 53·0 (26·4) | 24 | 54·8 (30·2) | 23 | .. | .. |
| 4-month follow-up | 46·2 (24·6) | 19 | 62·4 (31·1) | 18 | .. | .. |
Values are means (SD) and n for valid assessments at each timepoint, and estimated difference in slopes (95% CI) for modified intention-to-treat treatment linear random effects analysis during ECT treatment alone adjusting for age at randomisation, sex, baseline degree of treatment resistance, electrode placement (bilateral or unilateral), and baseline value. Negative values favour saline. BPRS=Brief Psychiatric Rating Scale (18-item). CAS=Clinical Anxiety Scale (6-item). CGI=Clinical Global Impression. EQ-5D-3L (VAS)=EuroQol 3 level version (Visual Analogue Scale). MADRS=Montgomery-Åsberg Depression Rating Scale. QIDS-SR=Quick Inventory of Depression Symptomatology-Self Report.
Mid-ECT for these outcomes were defined as 2 weeks after baseline.