Wagner 2005.
| Methods | Allocation: random, medication containers according to a pseudo‐random computer algorithm. Blindness: double, no further details. Duration: 8 weeks. Design: parallel. | |
| Participants | Diagnosis: schizophrenia (DSM‐IV and ICD‐10). N=52. Age: 18‐65 years (amisulpride mean=38.3 years, olanzapine mean=34.3 years). Sex: 23M, 13F*. Location: single centre. Setting: inpatient. History: CGI score > 4, PANSS score > 61, mean duration illness=8.4 years, age at onset 27.9 years* Excluded: risk of suicide or aggressive behaviour, previous CNS trauma, epilepsy, instable somatic condition, drug dependence, lack of sufficient contraception, drug resistance. | |
| Interventions | 1. Amisulpride: flexible dose. Allowed dose range: 400‐800 mg/day. Mean dose: 511.1 mg/day. N=26. 2. Olanzapine: flexible dose. Allowed dose range: 10‐20 mg/day. Mean dose: 15.0 mg/day. N=26. | |
| Outcomes | Global State: CGI. Leaving the study early: any reason, adverse events, inefficacy. Mental State: PANSS total score, PANSS positive subscore, PANSS negative subscore, SANS total score. Cognitive Functioning: Global Cognitive Index total score, trail making test A & B, continuous performance test, self ordered pointing task, Rey auditory verbal learning test. Adverse effects: EPS, SAS. | |
| Notes | * data only available for 36 participants. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Random, medication containers according to a pseudo‐random computer algorithm. |
| Allocation concealment (selection bias) | Unclear risk | No further details. |
| Blinding (performance bias and detection bias) Objective outcomes | Low risk | Double, no further details. Objective outcomes such as laboratory measures or death are unlikely to have been much affected by problems of blinding. |
| Blinding (performance bias and detection bias) Subjective outcomes | Unclear risk | Double, no further details. Whether blinding was successful has not been examined, but both compounds differ quite substantially in side effects. This can be a problem for blinding. |
| Incomplete outcome data (attrition bias) | High risk | The rate of participants leaving the study early was high (50%). The last‐observation‐carried‐forward method was used to account for people leaving the study early. It assumes that a participant who discontinued the study would not have had a change of his condition if he had remained in the study. This assumption can often be wrong and lead to bias in cases of high attrition. |
| Selective reporting (reporting bias) | High risk | Additional treatment with biperiden up to 4mg/day was permitted, but data on use of antiparkinson medication was not available. |
| Other bias | High risk | The study was sponsored by the manufacturer of olanzapine. |
Diagnostic tool DSM III‐R and DSM‐IV ‐ Diagnostic Statistical Manual version 3 Revised and version 4. ICD 10 ‐ The International Statistical Classification of Diseases and Related Health Problems.
Rating Scales:
Global rating scales: CGI ‐ Clinical Global Impressions. CGI‐S ‐ Clinical Global Impression‐Severity. CGI‐I ‐ Clinical Global Impression‐Improvement.
Mental state: BPRS ‐ Brief Psychiatric Rating Scale. MADRS ‐ Montgomery‐Asberg Depression Rating Scale. MMSE ‐ Wiing Mini Mental State Examination. PANSS ‐ Positive and Negative Syndrome Scale. SANS ‐ Scale for the Assessment of Negative Symptoms. SAPS‐ Scale for the Assessment of Positive Symptoms.
General functioning: GAF ‐ Global assessment of functioning.
Side effects: AIMS ‐ Abnormal Involuntary Movement Scale. BAS ‐ Barnes Akathisia Scale. ESRS ‐ Extrapyramidal Syndrome Rating Scale. SAS ‐ Simpson‐Angus Index ‐ for neurological side effects. UKU ‐ Udvalg for kliniske undersogelser side effect ratings.
Quality of Life: QLS ‐ Quality of Life Scale. SWN ‐Subjective Well‐being List.