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

Gallant 1967.

Methods Randomisation: “randomly assigned”.
Blinding: double‐blind.
Duration: 30 days.
Design: parallel (three‐arm study with chlorpromazine as third treatment group).
Location: Southeast Louisiana Hospital, Mandeville, Louisiana.
Setting: inpatients.
Participants Diagnosis: schizophrenia.
N = 39.
Gender (including participants of the chlorpromazine study group, N = 58): 30M, 28F.
Age (including participants of the chlorpromazine study group, N = 58): mean 33.4 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.
Interventions 1. Haloperidol: fixed/flexible dose: not indicated, dose range: maximum dose 16 mg/day, mean dose: not indicated. N = 19.
2. Trifluperidol: fixed/flexible dose: not indicated, dose range: maximum dose 4 mg/day, mean dose: not indicated. N = 20.
 
Rescue medication: “use of anti‐parkinson medication (Artane) prophylactically for all subjects throughout the study”.
Administration of benztropine (Cogentin, 2 mg i.m.) was allowed.
Outcomes Examined:
Clinically important response to treatment: Global Rating of Improvement.
Adverse effects: at least one movement disorder, dyskinesia, hypotension.
Unable to use:
Mental state general: Beckomberga Rating Scale (no SDs available and no imputation method could be applied).
Behaviour: MACC Behavioral Adjustment Scale (no raw data available).
Behaviour: Tulane Test Battery (no raw data available).
Notes In a third study arm of this trial chlorpromazine was investigated.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk “Randomly assigned”. No further details.
Allocation concealment (selection bias) Unclear risk No further details.
Blinding (performance bias and detection bias) 
 (performance bias) Low risk “Double‐blind”. “All drugs were supplied in identical capsules and were dispensed from individual medication bottles which were prepared and coded prior to the study.”
Blinding (performance bias and detection bias) 
 (detection bias) Unclear risk “Double‐blind”. No further details.
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk The study did not address this outcome; insufficient information to permit judgment concerning incomplete outcome data.
Selective reporting (reporting bias) High risk Outcome data were not fully addressed (no raw data for the MACC Behavioral Adjustment Scale and the Tubane Test Battery; no SDs were provided  for the Beckomberga Scale). Adverse effects reporting was incomplete.
Other bias Unclear risk Insufficient information to assess whether an important risk of bias exists.