Summary of findings 2. Clozapine: very low dose (up to 149 mg/day) versus standard dose (301 mg/day to 600 mg/day) for schizophrenia.
CLOZAPINE: VERY LOW DOSE (up to 149 mg/day) versus STANDARD DOSE (301‐600 mg/day) for schizophrenia | ||||||
Patient or population: patients with schizophrenia Settings: Intervention: Clozapine: very low dose (up to 149 mg/day) versus standard dose (301 mg/day to 600 mg/day) | ||||||
Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of Participants (studies) | Quality of the evidence (GRADE) | Comments | |
Assumed risk | Corresponding risk | |||||
Control | Clozapine: very low dose (up to 149 mg/day) versus standard dose (301 mg/day to 600 mg/day) | |||||
Global state: clinically important response, as defined by individual studies | See comment | See comment | Not estimable | 0 (0) | See comment | No study reported this outcome. |
Mental state: clinically important response, as defined by individual studies * Follow‐up: 16 weeks |
The mean clinical response: mental state ‐ average scores ‐ medium term endpoint (BPRS‐A, high = worse) in the intervention group was 6.67 higher (2.09 to 15.43 higher) | 31 (1 study) | ⊕⊝⊝⊝ very low1,2,3 | * Pre‐defined outcome not reported: Mental state measured as average endpoint scores (BPRS‐A, high = worse). | ||
Functioning: clinically important change in general functioning, as defined by individual studies | See comment | See comment | Not estimable | 0 (0) | See comment | No study reported this outcome. |
Adverse effect: clinically important adverse effect (weight ‐ BMI) Follow‐up: 6 weeks | The mean adverse effect ‐ any clinically important specific adverse effects ‐ BMI in the intervention group was 0.1 higher (0.76 lower to 0.96 higher) | 58 (1 study) | ⊕⊕⊝⊝ low2,3 | |||
Service use: number of days hospitalised | See comment | See comment | Not estimable | 0 (0) | See comment | No study reported this outcome. |
Service use: time to hospitalisation | See comment | See comment | Not estimable | 0 (0) | See comment | No study reported this outcome. |
Quality of life: clinically important change in general quality of life | See comment | See comment | Not estimable | 0 (0) | See comment | No study reported this outcome. |
*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; | ||||||
GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate. |
1 Risk of bias: rated as 'serious' (downgraded by 1) due to attrition bias, reporting bias, and sponsorship by Novartis Pharmaceuticals. 2 Indirectness: rated 'serious' (downgraded by 1) as proxy measure of pre‐defined outcome 3 Imprecision: rated 'serious' (downgraded by 1) as only one study providing data, small number of participants (less than 200)