Morton 1968.
Methods | Randomisation: random, no further details. Allocation: the hospital pharmacist was responsible for supplying placebo and active drugs to the ward, no one concerned with the care of patients knew which patients were started on placebo. Blinding: double, identical tablets, but in most cases nurses made correct forecasts on who was on drug and who was on placebo. Blinding was broken when a participant relapsed. Duration: 6 months. Design: parallel. Location: single‐centre. Setting: inpatients. | |
Participants | Diagnosis: chronic schizophrenia (clinical diagnosis by two psychiatrists). N = 20. Gender: 40 M. Age: 25‐55 years. History: duration stable ‐ maintenance doses of tranquillisers had been administered for at least 18 months, in six participants who had to change treatment no change in symptoms was noted during 6 weeks, duration ill ‐ n.i., number of previous hospitalisations ‐ n.i., but duration of current hospitalisation > 2 years, age at onset ‐ n.i., severity of illness ‐ n.i., baseline antipsychotic dose ‐ all but six participants were on chlorpromazine or trifluoperazine, dose n.i.. |
|
Interventions | 1. Trifluoperazine: fixed/flexible dose n.i., allowed dose range n.i., mean dose n.i.. N = 14. 2. Chlorpromazine: fixed/flexible dose n.i., allowed dose range n.i., mean dose n.i.. N = 6. Rescue medication: n.i.. |
|
Outcomes | Response to treatment: general clinical impression of the raters. Relapse: worsening of global state. Unable to use: Behaviour: Wing Scale (incomplete data, analysed by single items). |
|
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Random, no further details. |
Allocation concealment (selection bias) | Low risk | The hospital pharmacist was responsible for supplying placebo and active drugs to the ward, no one concerned with the care of patients knew which patients were started on placebo. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Double, identical tablets, but in most cases nurses made correct forecasts on who was on drug and who was on placebo. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Double, identical tablets, but in most cases nurses made correct forecasts on who was on drug and who was on placebo. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | It is unclear whether there were drop‐outs. |
Selective reporting (reporting bias) | Low risk | No evidence for selective reporting. |
Other bias | Unclear risk | Blinding was broken when a participant relapsed, but this is not a problem for our primary outcome response to treatment. |