Fuentenebro 1989.
Methods | Randomisation: implied randomisation. Blinding: double‐blind. Duration: 2 weeks. Design: parallel. Location: not indicated. Setting: not indicated. |
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Participants | Diagnosis: schizophrenia (DSM‐III). N = 50. Gender: not indicated. Age: not indicated. History: duration stable: not indicated, duration of illness: not indicated, number of previous hospitalisations: not indicated, 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: not indicated, mean dose: not indicated. Initial 5 mg injection, change to oral medication within the first 24 to 48 hours. N = not indicated. 2. Molindone: fixed/flexible dose: not indicated, dose range: not indicated, mean dose: not indicated. Initial 2 mg injection, change to oral medication within the first 24 to 48 hours. N = not indicated. |
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Outcomes | Unable to use: Global state general: Clinical Global Impression (CGI) (no raw data available). Mental state general: Brief Psychiatric Rating Scale (BPRS) (no total score available for both study groups, no SDs available). |
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Notes | The primary aim of the study was to evaluate the patient`s response to antipsychotic agents as predictor of treatment response. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | The trial authors did not explicitly mention a randomisation, but described a double‐blinding. Thus we implied that the study was randomised. |
Allocation concealment (selection bias) | Unclear risk | No further details. |
Blinding (performance bias and detection bias) (performance bias) | Unclear risk | “Double‐blind”. No further details. |
Blinding (performance bias and detection bias) (detection bias) | Unclear risk | “Double‐blind”. No further details. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | With missing data of 10 of the 50 randomised participants (20%), the overall attrition was moderate. The analyses were based on completers‐only data, but due to the moderate drop‐out rate, the risk of bias might be considered as being unclear. |
Selective reporting (reporting bias) | High risk | The outcome data were not fully addressed (no usable data and SDs for the BPRS; no raw data for the CGI). The numbers of participants randomised to each treatment group (haloperidol or molindone) were not indicated. |
Other bias | Unclear risk | Insufficient information to assess whether an important risk of bias exists. |