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. |
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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. |
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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. |
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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). |
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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%. |
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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. |