Various drugs 1984b.
Study characteristics | ||
Methods | Randomisation: random, no further details. Allocation: procedure not described. Blinding: double‐blind, drug appearance was made identical with respect to powder, colour, taste and volume by adding a gastric acid. Duration: one year. Design: parallel. Location: single‐centre. Setting: outpatient. | |
Participants | Diagnosis: schizophrenia (DSM‐III), in remission or residual state. N = 87. Gender: 53 men, 34 women. Age: mean 41 years. History: duration stable‐ n.i., but in remission, duration ill‐ mean 8.2 years, number of previous hospitalisations‐ mean 3.4, age at onset‐ mean 32.8 years, severity of illness‐ in remission or residual symptoms, baseline antipsychotic dose‐ n.i.. |
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Interventions | 1. Drug: haloperidol combined with biperidine and nitrazepam. Fixed dose: 1 mg, 3 mg or 6 mg/day.* N = 37. 2. Drug: propericiazine combined with biperidine and nitrazepam. Fixed dose: 10, 30 mg/day or 60 mg/day.* N = 37. 3. Placebo combined with biperidine and nitrazepam. Duration of taper: 0 days. N = 13. Rescue medication: not indicated, probably no additional antipsychotic medication allowed. |
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Outcomes |
Examined Relapse: clinical judgement. Leaving the study early. Global state ‐ number of participants in sustained remission (study defined). Unable to use/Not included Prolactin levels (no predefined outcome of interest). |
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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) | Unclear risk | Procedure not described. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Double‐blind, drug appearance was made identical with respect to powder, colour, taste and volume by adding a gastric acid. |
Blinding (performance bias and detection bias) Subjective outcomes | Unclear risk | Double‐blind, drug appearance was made identical with respect to powder, colour, taste and volume by adding a gastric acid. |
Blinding (performance bias and detection bias) Objective outcomes | Low risk | Double‐blind, drug appearance was made identical with respect to powder, colour, taste and volume by adding a gastric acid. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | While in the placebo group and in the haloperidol group the rates of participants leaving early due to other reasons were low, 9 out of 12 participants in the propericiazine group discontinued due to overdose. It is questionable whether relapse rates could be accurately measured, because most participants did not reach the endpoint. |
Selective reporting (reporting bias) | Low risk | No evidence for selective reporting. |
Other bias | Low risk | No evidence for other bias. |