Haas 1982.
Methods | Randomisation: implied randomisation. Blinding: double‐blind. Duration: 30 days. Design: parallel. Location: not indicated. Setting: inpatients. |
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Participants | Diagnosis (ICD‐8): schizophrenia: paranoid‐hallucinatory type (ICD 295.3) (N = 19), schizophrenia: chronic undifferentiated type (ICD 295.0) (N = 10), schizophrenia: schizoaffective type (ICD 295.7) (N = 1). N = 30. Gender: 13M, 17F. Age: mean 39 years. 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: flexible dose, dose range: not indicated, mean final dose: 23.75 mg/day. N = 15. 2. Pimozide: flexible dose, dose range: not indicated, mean final dose: 20.36 mg/day. N 15. Allowed dose range: up to 60 mg/day for both drugs. “Initial dose for both drugs was 10–40 mg/day. This was increased up to the fifth day to 60 mg and then continued according to clinical needs.” Rescue medication: “Chloral hydrate (1,5/day) or, if necessary, promethazine (100mg/day) were given as sleep medication. Biperiden (2mg tablets was given if extrapyramidal signs were observed)." |
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Outcomes | Examined: Clinically important response to treatment: Overall clinical assessment at day 30. Mental state general: Brief Psychiatric Rating Scale (BPRS) (no SDs available). Leaving the study early due to any reason. Leaving the study early due to adverse effects. Adverse effects: akathisia, dyskinesia, rigor, tremor, use of antiparkinson medication, hypotension. Unable to use: Global state general: Clinical Global Impressions (CGI, modified severity scale) (modified version of the scale, no raw data available). Mental specific: ADMP (no results were provided). |
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Notes | Study participants were 30 “acutely hospitalised schizophrenic patients” (28 completers). No participant “received depot neuroleptics at least three weeks prior to hospitalisation”. |
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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) | Low risk | “Presentation of the drugs was identical in liquid form” |
Blinding (performance bias and detection bias) (detection bias) | Unclear risk | “Double‐blind”; No further details. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | There were no drop‐outs in the haloperidol‐group, but 2 of 15 (13.3%) participants left the trial early in the pimozide‐group. The overall‐attrition was 6.7% (2 of 30 participants). Altogether the attrition was rather low and the risk of bias might be considered as being low. |
Selective reporting (reporting bias) | High risk | The outcome data were not fully addressed (no SDs for the BPRS; no results for the ADMP‐rating; no raw data for the CGI). |
Other bias | Unclear risk | Insufficient information to assess whether an important risk of bias exists. |