Table 3.
Adverse Events
| No. of patients reporting AE | P | No. of patients reporting long-lasting (>24 h) AE | Median duration, d (range) | ||||
|---|---|---|---|---|---|---|---|
| Type of AE | ECT (n = 90) | Ketamine (n = 91) | ECT (n = 90) | Ketamine (n = 91) | ECT (n = 90) | Ketamine (n = 91) | |
| Euphoria | 0 | 19 | <.001 | 0 | 1 | ||
| Dissociative symptoms | 14 | 55 | <.001 | 3 | 7 | 1 (1–5) | 2 (1–11) |
| Anxiety | 16 | 41 | <.001 | 2 | 2 | 1 (1) | 1 (1) |
| Affect lability | 3 | 11 | .048 | 0 | 2 | 1 (1) | |
| Fatigue | 19 | 20 | n.s. | 6 | 4 | 7 (1–28) | 17 (1–27) |
| Sleep disturbance | 0 | 1 | n.s. | 0 | 1 | 6 (6) | |
| Confusion | 22 | 23 | n.s. | 5 | 1 | 1 (1–40) | 1 (1) |
| Paranoid delusions | 2 | 1 | n.s. | 0 | 0 | ||
| Amnesia | 26 | 8 | <.001 | 19 | 0 | 28 (1–365)a | |
| Vertigo | 22 | 63 | <.001 | 5 | 6 | 1 (1–5) | 2 (1–6) |
| Paresthesia | 2 | 3 | n.s. | 0 | 0 | ||
| Seizures | 2 | 0 | n.s. | 0 | 0 | ||
| Myoclonus | 1 | 0 | n.s. | 0 | 0 | ||
| Blurred vision | 0 | 18 | <.001 | 0 | 3 | 1 (1) | |
| Diplopia | 2 | 28 | <.001 | 0 | 0 | ||
| Headache | 72 | 20 | <.001 | 15 | 6 | 1 (1–3) | 1 (1–3) |
| Tinnitus | 2 | 1 | n.s. | 1 | 0 | 1 (1) | |
| Hypertonia | 4 | 1 | n.s. | 0 | 0 | ||
| Tachy/bradychardia | 6 | 0 | .029 | 0 | 0 | ||
| Hypotension | 1 | 0 | n.s. | 0 | 0 | ||
| Thrombosis/swelling | 1 | 1 | n.s. | 1 | 0 | 67 (67) | |
| Abdominal pain | 2 | 0 | n.s. | 1 | 0 | 3 (3) | |
| Emesis | 6 | 2 | n.s. | 0 | 0 | ||
| Constipation/diarrhea | 1 | 3 | n.s. | 0 | 2 | 4 (3–5) | |
| Nausea | 23 | 25 | n.s. | 3 | 4 | 1 (1–4) | 1 (1–2) |
| Salivation/dry mouth | 1 | 22 | <.001 | 0 | 2 | 2 (1–3) | |
| Sore throat | 3 | 1 | n.s. | 2 | 0 | 3 (2–4) | |
| Laryngo/bronchospasm | 5 | 0 | n.s. | 0 | 0 | ||
| Desaturation | 12 | 4 | .039 | 0 | 0 | ||
| Infection | 0 | 1 | n.s. | 0 | 0 | ||
| Skin irritation | 1 | 3 | n.s. | 0 | 0 | ||
| Muscle pain | 48 | 13 | <.001 | 26 | 4 | 2 (1–211) | 5 (1–11) |
| Urine retention | 0 | 1 | n.s. | 0 | 0 | ||
| ECT (n = 90) | Ketamine (n = 91) | P | |||||
| No. of patients reporting AE | 85 | 85 | n.s. | ||||
| No. of patients reporting long-lasting AEs | 49 | 21 | <.001 | ||||
| No. of AEs per participant | 7.8 ± 5.4 | 12.0 ± 10.9 | <.001 | ||||
| No. of patients reporting SAEs | 23 | 14 | .09 | ||||
| No. of suicide attempts | 6 | 4 | |||||
| No. of patients attempting suicide | 6 | 4 | |||||
| No. of suicides | 1 | 0 | |||||
Abbreviations: AE, adverse event; ECT, electroconvulsive therapy; n.s., non significant; SAE, serious adverse event. All AEs reported were classified as “very likely” or “probably” to be related to the treatment are included.
a A maximum duration of 365 days indicates the AE had not resolved at the 12-month follow-up.