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. 2016 Jul 2;2016(7):CD010832. doi: 10.1002/14651858.CD010832.pub2

Conley 2005.

Methods Allocation: randomised, randomisation was performed by the dispensing pharmacy.
Blindness: double‐blind.
Duration: 12 weeks (with 4‐ to 6‐week open‐label qualification phase prior to randomisation).
Setting: in‐patients, Maryland (USA)
Design: parallel.
Participants Diagnosis: schizophrenia (DSM‐III); therapy‐refractory.
N = 40.
Age:18‐65 years old.
Sex: men = 30 and women = 8.
Length of illness: not stated.
Included criteria: persistent positive psychotic symptoms at study entry ("moderate" severity ≥ 4 points on a 1‐ to 7‐point scale) on 2 of 4 psychosis items on the BPRS scale; persistent global illness severity (BPRS total score ≥ 45 points on the 18‐item scale and a CGI score of ≥ 4 points [moderately ill]); two prior failed treatment trials with two different antipsychotics at doses of 600 mg/day chlorpromazine equivalents, each of at least 6 weeks duration; no stable period of good social/occupational functioning within the previous 5 years.
Exclusion criteria: not stated.
Interventions 1. Fluphenazine: mean, 13.2 mg/day, SD 1.17 mg/day, n = 13.
2. Risperidone: mean, 4.31 mg/day, SD 0.63 mg/day, n = 13.
3. Quetiapine: mean, 463.6 mg/day, SD 50.5 mg/day, n = 12.
Outcomes Clinically important response: no clinical improvement*.
Global state: CGI severity score.
Mental state: BPRS (global score; negative, positive, anxiety‐depression score, hostility, activation score).
Adverse effects.
Leave the study early.
Unable to use ‐
Simpson Angus Scale (SAS), the Barnes Akathisia Scale (BAS), and the Assessment of Involuntary Movements Scale (AIMS), Sexual Function: Changes in Sexual Function Questionnaire (CSFQ) (no data reported).
Quality of life (no SD reported).
Adverse effect: the Prolactin‐Related Adverse Event Questionnaire (PRAEQ) (no data reported).
Notes Funding: National Institutes of Mental Health (NIMH grant MH‐47311); study medications supplied by Janssen Pharmaceutica and Astra‐Zeneca Pharmaceuticals.
* decreased rate of BPRS score < 20%.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote:"randomisation was performed by the dispensing pharmacy".(p.341)
Allocation concealment (selection bias) Unclear risk Not stated.
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Quote: "After a 4‐6 week open‐label trial with either olanzapine (or a typical antipsychotic other than fluphenazine), participants who did not achieve a 20% reduction in their total BPRS scores and who still had a total BPRS ≥35 points were randomly assigned. After open‐label phase, participants were randomised to double blind study." No further details.(p.164)
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Not stated.
Incomplete outcome data (attrition bias) 
 All outcomes High risk N = 40 participants randomised ‐ n = 2 pieces of data "lost" (p.165); only results for 38 participants reported.
Selective reporting (reporting bias) High risk SAS, BAS, AIMS, NOSIE, CHESS, CSFQ, PRAEQ were not well‐reported.
Other bias Unclear risk Funding: National Institutes of Mental Health (NIMH grant MH‐47311), study medications supplied by Janssen Pharmaceutica and Astra‐Zeneca Pharmaceuticals.