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. 2012 Nov 14;2012(11):CD006391. doi: 10.1002/14651858.CD006391.pub2

Hanlon 1969.

Methods Allocation: stratified randomisation. 
 Blindness: double. 
 Design: parallel. 
 Duration: 32 days (short‐term trial duration).
Location: not indicated. 
 Setting: inpatients.
Participants Diagnosis: schizophrenia (N = 135), not indicated (N = 55) (research psychiatrists´ diagnoses). 
 History: 75% of the patients were severely ill with at least one previous hospitalisation. 
 N = 190. 
 Age: mean 36 years. 
 Sex: 60 M, 130 F.
Interventions 1. Chlordiazepoxide: mean dose: 29 mg/d + thioridazine 468 mg/d. N = 65. 
 2. Placebo + thioridazine: mean dose: 470 mg. N = 61. 
 3. Imipramine: mean dose: 75 mg/d + thioridazine 429 mg/d. N = 64.
Outcomes Leaving the study early. 
 Leaving the study early due to adverse effects. 
 Leaving the study early due to inefficacy of treatment. 
 Global state: Global impression. 
 Adverse effects: blurred vision, constipation, drowsiness, dry mouth, headache, insomnia, nasal congestion, palpitation, parkinsonism, vertigo.
Unable to use: 
 Global state: CGI (incomplete numbers). 
 Mental state: IMPS, SGPG, Group Behavior Scale, MMPI, Depression Index (incomplete numbers). 
 Behaviour: NOSIE (incomplete numbers).
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Randomly assigned “within sex”; no further details.
Allocation concealment (selection bias) Unclear risk No further details.
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk “Double‐blind”, no further details.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk “Double‐blind”, no further details.
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk The attrition was rather low in the thioridazine plus placebo group (4.9%) but moderate in the thioridazine plus chlordiazepoxide group (16.9%), overall 11.1%. The trial authors provided a modified completer‐analysis.
Selective reporting (reporting bias) High risk The outcomes that are of interest in the review were not fully addressed (e.g. SDs are missing).
Other bias Unclear risk Insufficient information to assess whether an important risk of bias exists.