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. 2015 Jan 16;2015(1):CD009831. doi: 10.1002/14651858.CD009831.pub2

Stewart 1969.

Methods Randomisation: implied randomisation.
Blinding: double‐blind.
Duration: not indicated.
Design: cross‐over.
Location: not indicated.
Setting: not indicated.
Participants Diagnosis: chronic schizophrenia.
N = 50.
Gender: 34M, 16F.
Age: mean 48.6 years.
History: duration stable: not indicated, duration of illness: mean 21.15 years, number of previous hospitalisations: not indicated, age at onset: not indicated, severity of illness: mean symptom severity of 1.9 (1 = mild, 2 = moderate, and 3 = severe), baseline antipsychotic dose: not indicated.
Interventions 1. Haloperidol: fixed/flexible dose: not indicated, dose range: not indicated, mean dose: 10.4 mg/day. N = 25.
2. Trifluoperazine: fixed/flexible dose: not indicated, dose range: not indicated, mean dose: 14.3 mg/day. N = 25.
 
Rescue medication: antiparkinson drugs were administered to control extrapyramidal side effects.
Outcomes Examined:
Global Response assessment (senior staff psychiatrist).
Leaving the study early due to any reason.
Leaving the study early due to inefficacy of treatment.
Leaving the study early due to adverse effects.
Adverse effects: at least one adverse effect, at least one movement disorder.
Unable to use:
Mental state general: modified Brief Psychiatric Rating Scale (BPRS) (mentioned in the abstract, but not in the methods and results section of the publication).
Mental state general: Inpatient Multidimensional Psychiatric Scale (IMPS) (mentioned in the abstract, but not in the methods and results section of the publication).
Mental state general: Rockland‐Pollin scales (mentioned in the abstract, but not in the methods and results section of the publication).
Behaviour: MACC rating scale (no total score available).
Notes Study participants were “patients with chronic schizophrenia of long duration".
“A drug‐free and placebo period preceded the course of treatment with the first drug.”
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 Low risk “All 50 patients completed all phases of the evaluation.” “Absence of any attrition in the study population.”
Selective reporting (reporting bias) High risk The duration of the trial was not indicated. No information regarding the number of participants that received a medication with antiparkinson drugs. Some rating scales (BPRS, IMPS, and Rockland‐Pollin scales) were mentioned in the abstract of the publication but no results of these scales were provided.
Other bias High risk Cross‐over study design. Because of epileptic convulsions the drug administration was temporally discontinued in one participant receiving haloperidol.