Methods | Allocation: random, no further details. Blindness: double, no further details. Duration: 6 weeks. Design: parallel. |
|
Participants | Diagnosis: (DSM-IV) schizophrenia, schizophreniform disorder, schizoaffective disorder, delusional disorder or shared psychotic disorder. N = 36. Age: 65 years or more. Sex: not described. Location: not described. Setting: not described. History: duration ill, age at onset: not described. Excluded: conditions such as: not described. |
|
Interventions |
|
|
Outcomes | Leaving the study early: adverse events. Cognitive functioning: MMSE. Adverse effects: open interviews. Unable to use: Mental state, PANSS total score, BPRS total score: no usable data. Cardiac effects (QTc), laboratory tests: no 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? subjective outcomes |
Unclear risk | Double, no further details. Whether blinding was successful has not been examined, but both compounds differ in side effects. This may be a problem for blinding |
Blinding? objective outcomes |
Low risk | Objective outcomes such as laboratory measures or death are unlikely to have been much affected by problems of blinding |
Incomplete outcome data addressed? All outcomes |
High risk | Numbers of participants leaving the study early were only reported for the category “due to adverse effects”. The statistical method used to account for incomplete data was not described |
Free of selective reporting? | High risk | The study is only available as an abstract. The data for primary outcomes were either not available or only available in percentage change without a standard deviation |
Free of other bias? | High risk | The study was sponsored by the manufacturer of amisulpride. Whether there was a baseline imbalance could not be judged due to insufficient data |