Hale 2000.
| Methods | Allocation: randomised, no further details. Blinding: double, participants were administered matching placebo in addition to their randomised treatment, all participants took 3x tablets and 2x capsules every day. Duration: 8 weeks (preceeded by 3‐7 day washout period). Multicentre: 89 European sites (11 European countries). Power calculation: none reported | |
| Participants | Diagnosis: schizophrenia (DSM‐III‐R). Included: Score >2 for at least two of the following PANSS items (sum of scores >=8): conceptual disorganisation, hallucinatory behaviour, suspiciousness, unusual thought content; <3 for all items on Simpson‐Angus scale and AIMS. Excluded: Non‐responders to any antipsychotic agent within the pat 5 years; unrateable using the battery of psychiatric and movement rating scales; current primary psychiatric diagnosis other than schizophrenia; confounding medical or neurological disorders; history of substance abuse; clinically relevant electrocardiogram (ECG) abnormalities; decrease in PANSS score >=20 over a 7‐day placebo run. N=617. Sex: 400/595 were male (intention‐to‐treat population). Age range: 17‐66 Setting: inpatients. | |
| Interventions | 1. Sertindole: fixed dose 8mg/day. N=120. 2. Sertindole: fixed dose 16mg/day. N=127. 3. Sertindole: fixed dose 20mg/day. N=128. 4. Sertindole: fixed dose 24mg/day. N=117. 5. Haloperidol: fixed dose 10mg/day. N=125. | |
| Outcomes | Mental state (Improvement in mean PANSS (=30%; =40%; =50%)).
Leaving study early (unacceptable treatment response, patient's decision to leave, adverse events).
Adverse effects (movement disorders ‐ documented EPS, prolonged QT/QTc intervals, COSTART list of adverse events). Unable to use ‐ Global state (CGI‐Severity ‐ no SD). Mental state (PANSS total, positive, negative ‐ no SD). Adverse effects (weight gain ‐ no actual data or SD, abnormal ejaculation ‐ denominators not given). Extrapyramidal side effects (BAS, SAS, AIMS ‐ no actual data or SD) Hospital utilisation (no. of days in hospital ‐ no SD). Other (suicidal tendency and suicidal attempt ‐ sertindole dose not given) |
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| Notes | STUDY 933032 Intention‐to‐treat analysis used last observation carried forward. 22 participants were missing from the ITT analysis, which included all those who received a baseline PANSS evaluation after their first dose of randomised treatment, but not more than one day after the last dose of trial medication. The identification of EPS related adverse events and the classification of anticholinergic medication were carried out before breaking the randomisation. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment? | Unclear risk | B ‐ Unclear |