Goff 2013.
Methods | Allocation: randomised, no further details Blinding: double, no further details Duration: 11 weeks; 3 weeks non‐randomised open‐label run‐in phase and 8 weeks randomised double‐blind phase. Design: parallel Location: multi‐centre (USA) Setting: inpatients (N = 30) and outpatients (N = 45) | |
Participants | Diagnosis: schizophrenia or schizoaffective disorder (DSM‐IV) N = 75 Gender: 52 men, 23 women Age: mean 40 years (SD = 11.9), range 16 to 65 years History: age at onset mean 25 years (SD = 9.1), no further details | |
Interventions | All participants firstly received open‐label ziprasidone treatment, titrated up to 160 mg/day, for a minimum of 3 weeks. Participants with persistent psychotic symptoms defined by a score of 4 (moderate) or greater on any item of PANSS despite ziprasidone treatment were then randomised to either: 1. dose increase: ziprasidone 320 mg/day; dose could be decreased to 240 mg/day. N = 38; or 2. dose maintenance: ziprasidone 160 mg/day. N = 37. Rescue medication: benztropine, propranolol, lorazepam, zolpidem; no further details. |
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Outcomes | Global state: clinically relevant response (defined as ≥20% PANSS total score reduction) Mental state: positive symptoms (PANSS positive subscore) Adverse effects: cardiac — QTc prolongation (number of participants with QTc longer than 500 msec) Unable to use: Leaving the study early (numbers not presented) Overall mental state (PANSS total score, no mean, no SD) Global state (change in CGI‐I, no SD; and CGI‐S, no mean, no SD) Negative symptoms (PANSS negative subscore, no mean, no SD) Depression (Calgary Depression Rating Scale (CDRS), no mean, no SD) Functioning (Global Assessment of Functioning, GAF, no mean, no SD) Adverse effects (EPS ‐ SAS (no mean, no SD), Akathisia ‐ BAS (no mean, no SD), tardive dyskinesia ‐ AIMS (no mean, no SD), Side Effect Checklist (no numbers), rate of adverse effects (no SD)) Vital signs (no numbers) Plasma levels (no SD) Cognition (Schizophrenia Cognition Rating Scale, no mean, no SD) |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "...eligible patients were randomly assigned to ziprasidone 40 mg capsules or matching placebo in a 1:1 ratio stratified according to the duration of prior ziprasidone treatment..." (pg. 486); no further details. |
Allocation concealment (selection bias) | Unclear risk | No details were presented |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote: " For the 8‐week double‐blind, placebo‐controlled trial..." (pg. 486); no further details. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: " For the 8‐week double‐blind, placebo‐controlled trial..." (pg. 486); no further details. |
Incomplete outcome data (attrition bias) All outcomes | High risk | 44% of the participants left the study early. Numbers per group as well as reasons for leaving the study early were not specified. For the primary outcome of clinically relevant response, only completers were analysed. |
Selective reporting (reporting bias) | High risk | PANSS total score, PANSS negative sbscore, CGI, CDRS, SCoRS, SAS, BAS, AIMS, Side Effect Checklist, vital signs and plasma levels were assessed but no usable data were reported in the results. |
Other bias | Low risk | No obvious risk for other bias |