Methods | Allocation: random, no further details. Blindness: double, no further details. Duration: 8 weeks. Design: parallel. Location: multicentre. Countries: France, Italy, Tunisia. |
|
Participants | Diagnosis: (DSM-IV) schizophrenia and comorbid depression, disorganised (n=26), paranoid (n=32), residual (n=4) or undifferentiated (n=23) . N=85. Age: 18-65 years (mean=34 years). Sex: 54 M, 31 F. History: duration ill not reported, age at onset not reported. Setting: in- and outpatient. |
|
Interventions |
|
|
Outcomes | Leaving the study early: any reason, adverse events, inefficacy. Global State. Mental State: PANSS total score, BPRS total score, PANSS positive subscore, PANSS negative subscore, Calgary depression scale. Adverse effects: open interviews, cardiac effects (QTc), EPS (tremor), weight, laboratory (cholesterol, glucose) Unable to use - Tremor: (no usable data). |
|
Notes | ||
Risk of bias | ||
Bias | Authors’ judgement | Support for judgement |
Adequate sequence generation? | Unclear risk | Random, no further details. |
Allocation concealment? | Unclear risk | No further details. |
Blinding? Objective outcomes |
Low risk | Objective outcomes such as laboratory measures or death are unlikely to have been much affected by problems of blinding |
Blinding? Subjective outcomes |
Unclear risk | Double, no further details. Whether blinding was successful has not been examined, but both compounds differ quite substantially in side-effects. This can be a problem for blinding |
Incomplete outcome data addressed? All outcomes |
Low risk | The rate of participants leaving the study early was 16.5% and reasons for leaving the study early were provided. The analysis was based on the last-observation carried forward method with two people being excluded due to no exploitable outcome data. In addition there was a per protocol population which excluded subjects with a major protocol deviation. As two different methods with similar results were applied and as the overall attrition was low we do not think that there was a bias |
Free of selective reporting? | High risk | Data on extrapyramidal symptoms were not provided. |
Free of other bias? | High risk | The study was sponsored by the manufacturer of amisulpride. Additionally there was a relatively high number of subjects (18) with major protocol deviations |