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. 2020 Aug 11;2020(8):CD008016. doi: 10.1002/14651858.CD008016.pub3

Various drugs 1961.

Study characteristics
Methods Randomisation: random, no further details.
Allocation: only the hospital pharmacist had the code on what medication the patient was on.
Blinding: double‐blind, identical capsules, each participant had his own container.
Duration: 16 weeks.
Design: parallel.
Location: single‐centre.
Setting: inpatient.
Participants Diagnosis: schizophrenia (clinical diagnosis), all withdrawn of subject to periodic disturbances, all needed supervision or management.
N = 80.
Gender: 80 men.
Age: younger than 55 years, mean 40.6 years.
History: duration stable‐ n.i. ("participants had attained and maintained some degree of improvement”), duration ill‐ n.i., but mean duration of current hospitalisation 10 years, number of previous hospitalisations‐ mean 1.6, age at onset‐ n.i., severity of illness‐ n.i., but "most required closed ward care”, median baseline antipsychotic dose‐ chlorpromazine 475 mg/day (N = 30), mepazine 200 mg/day (N = 35), trifluoperazine 30 mg/day (N = 6), prochlorpromazine (N = 2, dose not indicated), combinations of drugs (N = 7, doses not indicated)
Interventions 1. Drug: chlorpromazine; flexible dose; allowed dose range 200 mg/day to 1000 mg/day; mean dose: 894 mg/day (here mean maximum dose); N = 20
2. Drug: trifluoperazine; flexible dose; allowed dose range 10 to 50 mg/day; mean dose: 29 mg/day (here mean maximum dose); N=20
3. Drug: thioridazine; flexible dose; allowed dose range 200 mg/day to 1000 mg/day; mean dose: 958 mg/day (here mean maximum dose); N = 20
4. Placebo: duration of taper: 0 days; N = 20
Rescue medication: phenobarbital and bentropine methansulfonate, no additional antipsychotic drugs
Outcomes Examined
Relapse: worsening of global state
Leaving the study early.
Global state ‐ number of participants improved (clinical judgement, categories comparable to CGI).
Adverse effects: clinical interview, number of participants receiving antiparkinson medication
Unable to use/Not included
Behaviour: Manifest Behaviour Scale (no SD/no predefined outcome of interest)
Personality traits: Minnesota Multiphasic Personality Inventory (MMPI) (no SD/no predefined outcome of interest)
Notes The results of all drug groups were pooled.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Random, no further details
Allocation concealment (selection bias) Low risk Only the hospital pharmacist had the code on what medication the patient was on
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Double‐blind, identical capsules, each participant had his own container.
Blinding (performance bias and detection bias)
Subjective outcomes Unclear risk Double‐blind, identical capsules, each participant had his own container.
Blinding (performance bias and detection bias)
Objective outcomes Low risk Double‐blind, identical capsules, each participant had his own container.
Incomplete outcome data (attrition bias)
All outcomes Low risk Only 3 out of 80 participants left the study early and the reasons were well described.
Selective reporting (reporting bias) Low risk No selective reporting.
Other bias Low risk No evidence for other bias.