Skip to main content
. 2015 Jan 16;2015(1):CD009831. doi: 10.1002/14651858.CD009831.pub2

Cocito 1970.

Methods Randomisation: “randomly assigned”.
Blinding: double‐blind.
Duration: “very flexible” (haloperidol‐group: mean duration: 51 days (range from 10 to 160 days); dehydrobenzperidol‐group: mean duration: 75 days (range from 12 to 160 days))
Design: parallel.
Location: Ospedale Psichiatrico Provinciale di Genova, Istituto di Genova‐Quarto (Italy).
Setting: inpatients (at least for the beginning of the trial).
Participants Diagnosis: paranoid schizophrenia (N = 22), hebephrenic schizophrenia (N = 10), catatonic schizophrenia (N = 2), atypical delusion syndrome (N = 1), other forms of schizophrenia (N = 10).
N = 46.
Gender: 46 M.
Age: mean 34.5 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: not indicated, mean dose: 6.0 mg/day. N = 23.
2. Dehydrobenzperidol (=Droperidol): fixed/flexible dose: not indicated, dose range: not indicated, mean dose: 6.32 mg/day. N = 22.
Rescue medication: “The basic neuroleptic treatment with either dehydrobenzperidol or haloperidol was supplemented with orphenadrine, levopromazine, and in about one half of the cases diazepam.” Antidepressants in two cases.
Outcomes Examined:
Clinically important response to treatment: Therapeutic results at 60 days.
Mental state general: Rating Scale for Quantification of Psychotic Symptom Severity (RSQPSS).
Adverse effects: at least one adverse effect, at least one movement disorder, akathisia, tremor.
Notes Analysis was performed based on the data at 30 days (compromising altogether 40 participants) and 60 days (compromising altogether 12 participants).
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”; The two drugs were administered “in identical bottles of the same potency and coded so as to be unrecognisable both to the experimentalists and to the patients.”
Blinding (performance bias and detection bias) 
 (detection bias) Unclear risk “Double‐blind”. No further details.
Incomplete outcome data (attrition bias) 
 All outcomes High risk Regarding the analysis at day 30, data of 40 of 46 randomised participants were available (13% missing data) and at day 60, data of only 12 of 46 randomised participants were provided (73.9% missing data). The trial authors used a completers‐only analysis.  
Selective reporting (reporting bias) Low risk The outcomes have been reported in the pre‐specified way.
Other bias High risk “The basic neuroleptic treatment with either dehydrobenzperidol or haloperidol was supplemented with orphenadrine, levopromazine, and in about one half of the cases diazepam.” Antidepressants were administered in two cases. Significant between‐group difference regarding the average trial duration (51 versus 75 days).