Table 6.
Secondary outcomes (adverse effects)
| Antipsychotics (n=21) | CBT (n=20) | Antipsychotics plus CBT (n=21) |
Mean difference (SE; 95% CI); p value |
|||||
|---|---|---|---|---|---|---|---|---|
| CBT vs antipsychotics | CBT vs antipsychotics plus CBT | Antipsychotics vs antipsychotics plus CBT | ||||||
| ANNSERS | ||||||||
| Number of side-effects | .. | .. | .. | 3·22 (1·35; 0·58 to 5·87); 0·017 | 3·99 (1·35; 1·36 to 6·64); 0·003 | 0·78 (1·37; −1·91 to 3·47); 0·572 | ||
| Week 0 | 8·52 (3·66), 21 | 8·55 (3·94), 20 | 10·33 (4·54), 21 | .. | .. | .. | ||
| Week 24 | 8·47 (5·62), 17 | 5·7 (3·23), 20 | 10·05 (5·35), 19 | .. | .. | .. | ||
| Week 52 | 9·06 (5·5), 16 | 4·74 (3·35), 19 | 10·42 (5·90), 19 | .. | .. | .. | ||
| Total score | .. | .. | .. | 5·12 (2·05; 1·11 to 9·14); 0·012 | 6·30 (2·03; 2·32 to 10·27); 0·002 | 1·17 (2·07; −2·89 to 5·24); 0·571 | ||
| Week 0 | 11·57 (5·48), 21 | 11·7 (6·21), 20 | 13·62 (6·18), 21 | .. | .. | .. | ||
| Week 24 | 11·59 (8·40), 17 | 7·45 (4·99), 20 | 14·16 (8·42), 19 | .. | .. | .. | ||
| Week 52 | 12·94 (8·77), 16 | 6·21 (5·07), 19 | 13·79 (7·63), 19 | .. | .. | .. | ||
| Cholesterol | ||||||||
| HDL (mmol/L) | .. | .. | .. | 0·07 (0·09; −0·10 to 0·24); 0·389 | 0·09 (0·09; −0·09 to 0·26); 0·346 | 0·01 (0·08; −0·15 to 0·17); 0·893 | ||
| Week 0 | 1·37 (0·35), 16 | 1·21 (0·32), 12 | 1·37 (0·41), 13 | .. | .. | .. | ||
| Week 12 | 1·37 (0·38), 14 | 1·21 (0·29), 9 | 1·54 (0·49), 15 | .. | .. | .. | ||
| Week 52 | 1·15 (0·36), 8 | 1·36 (0·31), 6 | 1·24 (0·21), 7 | .. | .. | .. | ||
| Total/HDL ratio | .. | .. | .. | −0·08 (0·22; −0·50 to 0·35); 0·722 | 0·01 (0·24; −0·45 to 0·48); 0·950 | 0·09 (0·21; −0·33 to 0·51); 0·667 | ||
| Week 0 | 3·4 (0·85), 16 | 3·58 (0·66), 12 | 3·06 (0·81), 13 | .. | .. | .. | ||
| Week 12 | 3·63 (1·25), 14 | 3·64 (0·44), 10 | 3·23 (0·65), 14 | .. | .. | .. | ||
| Week 52 | 4·41 (2·11), 8 | 3·51 (0·53), 7 | 3·68 (1·05), 6 | .. | .. | .. | ||
| LDL (mmol/L) | .. | .. | .. | −0·21 (0·28; −0·76 to 0·33); 0·449 | −0·15 (0·29; −0·72 to 0·42); 0·615 | 0·06 (0·26; −0·45 to 0·58); 0·809 | ||
| Week 0 | 2·42 (0·79), 14 | 2·44 (0·58), 10 | 2·34 (0·72), 11 | .. | .. | .. | ||
| Week 12 | 2·59 (0·72), 12 | 2·79 (0·92), 8 | 2·63 (0·74), 12 | .. | .. | .. | ||
| Week 52 | 3·02 (0·84), 6 | 2·83 (0·59), 6 | 2·63 (0·90), 6 | .. | .. | .. | ||
| Triglycerides (mmol/L) | .. | .. | .. | 0·08 (0·19; −0·29 to 0·45); 0·659 | −0·27 (0·20; −0·66 to 0·12); 0·170 | −0·35 (0·18; −0·71 to 0·00); 0·051 | ||
| Week 0 | 1·23 (0·45), 14 | 1·16 (0·56), 10 | 1·15 (0·58), 11 | .. | .. | .. | ||
| Week 12 | 1·45 (0·75), 12 | 1·4 (0·63), 8 | 1·11 (0·63), 13 | .. | .. | .. | ||
| Week 52 | 1·62 (1·11), 6 | 0·97 (0·28), 6 | 2·57 (4·08), 7 | .. | .. | .. | ||
| Prolactin (mU/L) | .. | .. | .. | 23·12 (26·73; −29·27 to 75·50); 0·387 | −7·39 (29·00; −64·22 to 49·44); 0·799 | −30·51 (28·28; −85·94 to 24·93); 0·281 | ||
| Week 0 | 162·86 (98·96), 14 | 188·42 (72·73), 12 | 221·58 (74·14), 12 | .. | .. | .. | ||
| Week 12 | 206·92 (83·76), 13 | 196·22 (83·08), 9 | 180 (73·90), 10 | .. | .. | .. | ||
| Week 52 | 136·71 (53·84), 7 | 201·83 (93·32), 6 | 186·13 (88·69), 8 | .. | .. | .. | ||
| Glucose (mmol/L) | .. | .. | .. | −0·56 (0·50; −1·53 to 0·42); 0·265 | −0·75 (0·52; −1·77 to 0·27); 0·148 | −0·19 (0·45; −1·07 to 0·68); 0·662 | ||
| Week 0 | 6·6 (7·63), 15 | 5·04 (2·68), 12 | 4·72 (0·95), 13 | .. | .. | .. | ||
| Week 12 | 4·76 (1·10), 11 | 5·2 (1·72), 7 | 4·55 (0·55), 14 | .. | .. | .. | ||
| Week 52 | 4·63 (0·65), 8 | 5·32 (1·81), 6 | 4·11 (0·76), 7 | .. | .. | .. | ||
| Weight (kg) | .. | .. | .. | 1·80 (1·40; −0·94 to 4·54); 0·198 | 3·70 (1·41; 0·93 to 6·47); 0·009 | 1·90 (1·36; −0·76 to 4·57); 0·162 | ||
| 0 | 75·91 (20·31), 21 | 73·62 (15·72), 18 | 70·93 (12·97), 21 | .. | .. | .. | ||
| 6 | 77·06 (18·20), 16 | 74·84 (17·27), 15 | 70·82 (13·56), 18 | .. | .. | .. | ||
| 12 | 72·87 (13·32), 16 | 73·58 (15·66), 19 | 73·86 (14·01), 19 | .. | .. | .. | ||
| 24 | 78·21 (17·38), 18 | 72·12 (15·14), 20 | 75·33 (13·59), 16 | .. | .. | .. | ||
| 52 | 74·87 (15·34), 16 | 75·71 (14·88), 15 | 75·22 (15·07), 18 | .. | .. | .. | ||
| Systolic blood pressure (mm Hg) | .. | .. | .. | 1·36 (2·76; −4·06 to 6·78); 0·624 | 0·52 (2·83; −5·04 to 6·07); 0·855 | −0·84 (2·44; −5·61 to 3·93); 0·730 | ||
| Week 0 | 124·12 (12·91), 20 | 124·05 (15·02), 14 | 118·98 (11·11), 19 | .. | .. | .. | ||
| Week 12 | 124·49 (16·53), 14 | 122·13 (10·16), 14 | 123·86 (14·13), 17 | .. | .. | .. | ||
| Week 52 | 123·6 (13·28), 16 | 122·22 (10·67), 10 | 116·9 (8·47), 18 | .. | .. | .. | ||
Data are mean (SD), number of observations on an as-treated basis, unless otherwise specified. CBT=cognitive behavioural therapy. ANNSERS=Antipsychotic Non-neurological Side Effects Rating Scale.
*ANNSERS consists of 43 non-neurological side-effects, each rated as absent (0), mild (1), moderate (2), or severe (3), with a total possible score of 129.