Serafetinides 1972.
| Methods | Randomisation: “randomly assigned”. Blinding: double‐blind. Duration: 12 weeks. Design: parallel (four‐arm study; additionally investigating chlorpromazine and placebo). Location: not indicated. Setting: inpatients. |
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| Participants | Diagnosis: chronic schizophrenia. N = 29. Gender: 12M, 17F. Age: mean 42.2 years. History: duration stable: not indicated, duration of illness: mean 14 years, number of previous hospitalisations: mean 12, age at onset: not indicated, severity of illness: not indicated, baseline antipsychotic dose: not indicated. |
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| Interventions | 1. Haloperidol: fixed/flexible dose: not indicated, dose range: 3 mg to 15 mg/day, mean dose: 12.3 mg/day. N = 14. 2. Clopenthixol: fixed/flexible dose: not indicated, dose range: 50 mg to 250 mg/day, mean dose: 205 mg/day. N = 15. Rescue medication: “concomitant medication for Parkinsonism or bedtime sedation, when necessary, was allowed.” |
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| Outcomes | Examined: Mental state general: Brief Psychiatric Rating Scale (BPRS) (no SDs available). Clinically important response to treatment: Clinical Global Impression (CGI) Improvement. Leaving the study early due to any reason. Leaving the study early due to inefficacy of treatment. Leaving the study early due to adverse effects. Adverse effects: at least one movement disorder, use of antiparkinson medication, hypotension, sedation, weight gain. Unable to use: Behaviour: Nurses´ Observation scale for Inpatient Evaluation (NOSIE) (no SDs available and no imputation method could be applied). Behaviour: Global clinical impression by the research nurse (no raw data available). Behaviour: Oklahoma Behavior Rating Scale (OBRS) (no total score available). |
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| Notes | Study participants were 29 “chronic schizophrenic subjects” (ill 2 years or longer). “12‐week dry‐out period” to dissipate the effects of previous treatment. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | “Randomly assigned”. No further details. |
| Allocation concealment (selection bias) | Unclear risk | No further details. |
| Blinding (performance bias and detection bias) (performance bias) | Low risk | “Double‐blind”. “All medications were prepared in identically appearing capsules.” |
| Blinding (performance bias and detection bias) (detection bias) | Unclear risk | “Double‐blind”. No further details. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing outcome data. In the two investigated (haloperidol and clopenthixol) study arms no participant left the trial early. |
| Selective reporting (reporting bias) | High risk | The outcome data were not fully addressed (no raw data for the NOSIE and OBRS; no SDs for the BPRS). |
| Other bias | Low risk | The study appears to be free of other sources of bias. |