Treatment outcome*
| Variable | Treatment group; no. of patients† | |
|---|---|---|
| Levomepromazine n = 19 | Chlorpromazine n = 19 | |
| Completed HAL phase, 60 mg/d × 4 wk | 12 | 13 |
| Advanced after HAL, 60 mg/d × 1–3 wk‡ | 6 | 2 |
| Advanced after HAL, < 60 mg/d‡ | 1 | 4 |
| Randomization phase completed | 17 | 14 |
| Premature withdrawal | 2 | 5 |
| Mean baseline neuroleptic dose (and SD), mg/d§ | 1611 (879) (n = 19) | 1872 (1333) (n = 19) |
| Mean final neuroleptic dose (and SD), mg/d | 813 (225) | 762 (199) |
| p value¶ | < 0.001 | < 0.002 |
| Mean baseline neuroleptic dose (and SD), mg/d (completers)§ | 1624 (914) (n =17) | 1623 (856) (n = 14) |
| Mean final neuroleptic dose (and SD), mg/d (completers) | 799 (234) | 763 (215) |
| p value¶ | < 0.001 | < 0.005 |
| BPRS totaldecrease ≥ 25% | 10 | 8 |
| Criteria of Kane et al4 for response | 6 | 4 |
| PANSS (total) decrease ≥ 25% | 11 | 6** |
| Mean baseline neuroleptic dose of responders (and SD), mg/d§ | 1715 (966) (n = 10) | 1763 (921) (n = 8) |
| Mean final neuroleptic dose of responders (and SD), mg/d†† | 710 (265) | 722 (272) |
| p value¶ | < 0.005 | 0.026 |
| Mean weight at baseline (and SD), kg | 71.5 (12.2) (n = 17) | 70.5 (20.2) (n = 12) |
| Mean weight at wk 30 (and SD), kg | 75.6 (12.9) | 75.4 (18.4) |
| p value¶ | 0.046 | 0.015 |
| Mean baseline QTc interval (and SD) | 0.446 (0.053) (n = 11) | 0.424 (0.025) (n = 12) |
| Mean QTc interval at wk 30 (and SD) | 0.429 (0.025) | 0.437 (0.024) |
| p value¶ | 0.29 | 0.12 |
BPRS = Brief Psychiatric Rating Scale; HAL = haloperidol; PANSS = Positive and Negative Syndrome Scale; SD = standard deviation.
↵* None of the between-group comparisons are significantly different.
↵† Unless otherwise indicated.
↵‡ Subjects advanced to randomized phase without reaching HAL, 60 mg/d × 4 wk.
↵§ Chlorpromazine equivalents.
↵¶ Within-group comparisons.
↵** Two additional subjects improved 21% and 24%, respectively.
↵†† Subjects showing a ≥ 25% reduction in total BPRS.