Saletu 1994.
| Methods | Allocation: randomised,no further details. Blindness: double‐blind. Duration: 3‐day washout period plus 6 weeks treatment period. Setting: in‐patients, Austria. Design: parallel. |
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| Participants | Diagnosis: DSM‐III schizophrenia. N = 40. Age: mean˜31 years,SD˜6.4 years. Sex: men = 32 and women = 8. Length of illness: mean 82.6˜118.3 months. Inclusion criteria:clinical diagnosis (ICD 9 criteria) of either a simple type (295.0), hebephrenic type (295.1) or residual type (295.6) of schizophrenia; minimal age of 18 years; minimal length of illness of 1 year; a necessity of 6 weeks in‐patient treatment. Exclusion criteria: an acute phase of a paranoid schizophrenia; pronounced symptoms of depression, neurotic asthenia or neurotic depression; reactive depressive psychosis; alcohol‐induced psychiatric disturbances; gravidity; physical illness; treatment with lithium salts; treatment with depot neuroleptics within the last 45 days; potential premature discontinuation of treatment. |
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| Interventions | 1. Fluphenazine: 2 mg/day to 4 mg/day, n = 21. 2. Amisulpride: 50 mg/day to 100 mg/day, n = 19. During the first 2 weeks, the dosage consisted of single doses of 50 mg/day amisulpride or 2 mg/day fluphenazine. From the third week up to the sixth, the daily doses were 100 mg amisulpride (50 mg twice daily) and 4 mg fluphenazine (2 mg twice daily). |
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| Outcomes | Global state: CGI Mental state: Association for Methodology and Documentation in Psychiatry (AMDP), SANS. Extrapyramidal adverse effects: Webster scale, contaminant of anticholinergic drugs. Adverse effect: Adverse experience questionnaire. Leave the study early. Unable to use: Global function: Grunberger AD test (Alphabetical cross‐out test); Grunberger psychomotor activity test; numerical memory test; Pauli test; reaction time test; complex reaction test; Zerssen well‐being scale; semantic differential polarity profile; state‐trait anxiety scale; CFF descending threshold; skin conductance (mean); skin conductance fluctuations. There is no SD reported and no reply from the author. Webster scale, Adverse experience questionnaire, EEG, no data reported on this outcome. |
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| Notes | Funding: Experimental drugs supplied by Synthelabo Recherche/Laboratoires Delagrange (Bagneux, France). | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "patients were included in the double‐blind, parallel group study" (p.127) |
| Allocation concealment (selection bias) | Unclear risk | Allocation concealment not described. |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote:"patients were included in the double‐blind, parallel group study" (p.127) |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: "patients were included in the double‐blind, parallel group study" (p.127) |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Out of 40 participants, five discontinued therapy prematurely. Three amisulpride participants dropped out due to productive symptoms (days 14, 28 and 35) while two fluphenazine participants dropped out due to depressive symptoms (days 21 and 28). |
| Selective reporting (reporting bias) | High risk | Webster scale, adverse experience questionnaire and EEG were not reported. |
| Other bias | High risk | Funding: Experimental drugs supplied by Synthelabo Recherche/Laboratoires Delagrange (Bagneux, France). |
AIMS ‐ Assessment of Involuntary Movements Scale AMDP ‐ Association for Methodology and Documentation in Psychiatry BAS – Barnes Akathisa Scale BPRS – Brief Psychiatric Rating Scale CFF: critical flicker frequency CGI – Cognitive Global Impression CHESS ‐ Changes in Health, End‐Stage, Disease, Signs, and Symptoms CSFQ ‐ Changes in Sexual Functioning Questionnaire DAI – Drug Attitude Inventory DSAS – Depression Anxiety and Stress Scale DSM‐III: Diagnostic and Statistical Manual, third edition DSM‐IV: Diagnostic and Statistical Manual, fourth edition ECG ‐ electrocardiogram HAMA ‐ Hamilton Anxiety Scale HAS ‐ Hillside Akathisia Scale ICD: International Classification of Diseases LSEQ – Leeds Sleep Evaluation Questionnaire NOSIE – Nurses’ Observation Scale for Inpatient Evaluation PANSS – Positive and Negative Syndrome Scale PRAEQ ‐ Prolactin Related Adverse Event Questionnaire SANS – Scale for Assessment of Negative Symptoms SAS – Simpson‐Angus Scale SD: standard deviation SE: standard error