Dossenbach 1998.
Methods | Allocation: randomised, no further information. Blindness: double‐blind. Duration: Acute phase: 6 weeks (2 to 9 days placebo lead‐in); long term: 22 weeks. Setting: hospital, multicentre, Croatia. Design: parallel. |
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Participants | Diagnosis: schizophrenia or schizoaffective disorder (DSM‐IV) N = 60. Age: mean˜35.4 years, SD˜10.4 years. Sex: men = 28 and women = 32. Length of illness: not stated. Inclusion criteria: schizophrenia, BPRS ≥ 42, CGI ≥ 4 . Exclusion criteria: pregnant or lactating women, serious or unstable illness; history of intolerance to olanzapine; DSM substance dependence excluding caffeine or nicotine within last 30 days; serious suicide risk; significantly elevated liver function results; active hepatitis B or current jaundice; received treatment with injectable neuroleptic within less than one dosing interval between depot neuroleptic injection prior to study entry; previously intolerant or non‐responsive to fluphenazine; previous participation in any olanzapine clinical trial; pregnancy or lactating; uncorrected hypothyroidism or hyperthyroidism, myasthenia gravis, narrow‐angle glaucoma, chronic urinary retention and/or clinically significant prostatic hypertrophy, a history of seizures, severe allergies or multiple adverse drug reactions, a history of leukopenia without known aetiology. |
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Interventions | 1. Fluphenazine: 5 mg to 20 mg/day, average, 11.7 ± 3.0 mg/day for acute phase (6 weeks) and 11.7 ± 3.0 mg/day for long term (22 weeks), n = 30. 2. Olanzapine: 6 mg to 21 mg/day, average, 13.6 ± 2.4 mg/day for acute phase (6 weeks) and 14.8 ± 2.5 mg/day for long term (22 weeks), n = 30. |
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Outcomes | Clinically important response: no clinical improvement*. Global state: CGI severity change score. Mental state: BPRS (global score; negative, positive change score); PANSS (total, positive, negative, general psychopathology change score), Hillside Akathisia Scale (HAS). Quality of Sleep scale: Leeds Sleep Evaluation Questionnaire (LSEQ) total and subscale score. Satisfaction: Drug Attitude Inventory (DAI). Extrapyramidal adverse effects: Simpson Angus Scale (SAS), and the Assessment of Involuntary Movements Scale (AIMS). Leave the study early. Unable to use: vital signs, ECG, laboratory findings, no data reported. HAMA subscale score. LSEQ in medium term, data not reported. |
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Notes | Funding: Eli Lilly and Company. *Two definitions: decreased rate of PANSS score < 40%, decreased rate of BPRS score < 40%.The data were reported separately in our data analysis based on these two definitions. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quotes: "Random allocation at a 1:1 ratio" (p.312) |
Allocation concealment (selection bias) | Unclear risk | Not reported. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote: "This was a long‐term, randomised, double‐blind parallel clinical trial" (p.312) |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote:"This was a long‐term, randomised, double‐blind parallel clinical trial" (p.312) |
Incomplete outcome data (attrition bias) All outcomes | High risk | Out of 60 participants, five (n = 3 olanzapine; n = 2 fluphenazine) were excluded from efficacy analysis because they did not meet inclusion criteria for BPRS or CGI. Three participants missing from DAI results because of no baseline data for two (n = 1 olanzapine; n = 1 fluphenazine) and one participant on fluphenazine discontinuing without having a DAI performed. Four participants in fluphenazine group discontinued because of adverse event. All participants were included in safety analysis. |
Selective reporting (reporting bias) | Low risk | All measured outcomes were well reported. |
Other bias | High risk | Funding: sponsored by Eli Lilly and Company. |