Table 5.
Adverse events and effects
| Treatment as usual (n=245) | Cognitive behavioural therapy plus treatment as usual (n=242) | OR (95% CI) | P value | ||
|---|---|---|---|---|---|
| Serious adverse events | |||||
| Participants who had a trial-related SAE | 1 (<1%) | 2 (1%) | .. | .. | |
| Life threatening or results in self-harm | 1 | .. | .. | .. | |
| Involuntary hospitalisation | .. | 1 | .. | .. | |
| Self-harm requiring treatment at accident and emergency | .. | 1 | .. | .. | |
| Adverse events or effects | |||||
| Participants who had at least one adverse event or effect | 104 (42%) | 107 (44%) | 1·09 (0·81–1·46) | 0·58 | |
| Total adverse events or effects* | 120 | 143 | .. | .. | |
| Death | 4 | 6 | .. | .. | |
| Voluntary hospitalisation | 24 | 33 | .. | .. | |
| Involuntary hospitalisation | 14 | 10 | .. | .. | |
| Prolongation of hospitalisation | 2 | 4 | .. | .. | |
| Risk to others | 0 | 2 | .. | .. | |
| Self-harm | 6 | 27 | .. | .. | |
| Suicide attempt | 3 | 2 | .. | .. | |
| Suicidal crisis (CDSS item 8, rating 2) | |||||
| 9 months | 14/224 (6%) | 12/215 (6%) | 0·90 (0·40–1·10) | 0·79 | |
| 21 months | 7/214 (3%) | 9/209 (4%) | 1·35 (0·49–3·73) | 0·56 | |
| Severe symptomatic exacerbation: CGI severity of 6 or more | |||||
| 9 months | 25/213 (12%) | 18/207 (9%) | 0·69 (0·36–1·33) | 0·27 | |
| 21 months | 17/212 (8%) | 19/208 (9%) | 1·16 (0·57–2·33) | 0·69 | |
| Severe symptomatic exacerbation: CGI improvement of 6 or more† | |||||
| 9 months‡ | 5/147 (3%) | 0/131 | NA | 0·062 | |
| 21 months | 6/157 (4%) | 3/141 (2%) | 0·45 (0·10–2·02) | 0·30 | |
| More than 25% deterioration in PANSS total | |||||
| 9 months | 28/224 (13%) | 22/218 (10%) | 0·75 (0·41–1·38) | 0·35 | |
| 21 months | 21/216 (10%) | 15/209 (7%) | 0·68 (0·33–1·37) | 0·28 | |
| More than 50% deterioration in PANSS total | |||||
| 9 months | 7/224 (3%) | 6/218 (3%) | 0·77 (0·25–2·43) | 0·66 | |
| 21 months | 8/216 (4%) | 8/209 (4%) | 0·90 (0·32–2·55) | 0·84 | |
| More than 75% deterioration in PANSS total | |||||
| 9 months | 1/224 (>1%) | 2/218 (1%) | 1·78 (0·15–20·95) | 0·65 | |
| 21 months | 3/216 (1%) | 1/209 (1%) | 0·26 (0·03–2·73) | 0·26 | |
Data are n, n (%), or n/N (%), unless otherwise stated. SAE=serious adverse event. CDSS=Calgary Depression Rating Scale for Schizophrenia. CGI=Clinical Global Impression Scale. NA=not applicable. PANSS=Positive and Negative Syndrome Scale.
*
Two participants had two involuntary hospitalisations, one participant had 22 self-harm events, one participant had two self-harm events, and nine participants had two voluntary hospitalisations.
†
High scores indicate deterioration.
‡
χ2 test.