Various drugs 1986a.
Study characteristics | ||
Methods | Randomisation: random, no further details. Allocation: allocation lists prepared by pharmacy for five antipsychotic drugs mentioned below, concealment is unclear. Blinding: double‐blind, no further details. Duration: 104 weeks. Design: parallel. Location: multi‐centre. Setting: outpatient. | |
Participants | Diagnosis: first episode of schizophrenia (Present State Examination). N = 120. Gender: 74 men, 46 women. Age: mean 26.3 years (range 16 to 59 years). History: duration stable‐ 30 days after discharge all on active medication, duration ill‐ 2.8 months (between illness onset and admission to hospital), number of previous hospitalisations‐ n.i., age at onset‐ n.i., severity of illness‐ most participants were ‘well’ at the beginning of the study (91 well, 13 psychotic features, 10 defect state, 6 unspecific symptoms), baseline antipsychotic dose‐ n.i.. |
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Interventions | 1. Drug: flupenthixol IM, chlorpromazine, haloperidol, pimozide, trifluoperazine Flexible dose. Allowed dose range: no upper limit, but lower limit was flupenthixol IM 40 mg/month, chlorpromazine 200 mg/day, haloperidol 3 mg/day, pimozide 4 mg/day, trifluoperazine 5 mg/day. Mean dose: flupenthixol 84 mg/month (N = 31), chlorpromazine 366 mg/day (N = 3), haloperidol 11.8 mg/day (N = 3), pimozide 7.8 mg/day (N = 5), trifluoperazine 11.5 mg/day (N = 12). N=54. 2. Placebo: duration of taper (days): 30 days on drug, then received half dose for 30 days before they were put on placebo. N = 66. Rescue medication: antiparkinson medication, antidepressants, anxiolytics. |
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Outcomes |
Examined Relapse: rehospitalisation or rehospitalisation thought necessary although not possible or need of medication. Leaving the study early. Unable to use/Not included Hallucinations, delusions (no data/no predefined outcomes of interest). Global state: clinical judgment of patients global state at endpoint (not usable data/no predefined outcome of interest) Death, Suicide attempts (no usable data, only reported for the total sample). Disturbed behaviour/non‐cooperation (no usable data, only reported for the total sample). Use of antiparkinson medication (unclearly reported, probably referred to the baseline intake). |
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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 | Allocation lists prepared by pharmacy for five antipsychotic drugs mentioned below, concealment is unclear. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Double‐blind, no further details. |
Blinding (performance bias and detection bias) Subjective outcomes | Unclear risk | Double‐blind, no further details. |
Blinding (performance bias and detection bias) Objective outcomes | Low risk | Double‐blind, no further details. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No clear bias. overall rate of leaving early of 11% is acceptable. Survival curve analysis was used for the primary outcome relapse. |
Selective reporting (reporting bias) | Low risk | No evidence for selective reporting. |
Other bias | High risk | Blind was broken when a participant relapsed. |