Various drugs 1993.
Study characteristics | ||
Methods | Randomisation: centrally randomised by a specialised unit using an "adaptive randomisation method”. Allocation: procedure not described. Blinding: open, only key rating scales were additionally rated by a second blind assessor. Duration: 2 years. Design: parallel. Location: multi‐centre. Setting: outpatient. | |
Participants | Diagnosis: schizophrenia or schizoaffective disorder (ICD‐9 and Research Diagnostic Criteria). N = 237. Gender: 124 women, 113 men. Age: mean 34.6 years. History: duration stable‐ at least 3 months in addition titrated to minimally effective dose which was maintained for at least 4 weeks, duration ill‐ mean 7.3 years, number of previous hospitalisations‐ n.i., age at onset‐ mean 27.3 years, severity of illness‐ mean CGI 3.8; mean BPRS total score 28.5, baseline antipsychotic dose‐ n.i.. |
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Interventions | 1. Drug: various antipsychotic drugs. Flexible dose, minimum 100 mg/day chlorpromazine equivalent. Allowed dose range: 100 mg ‐ unlimited chlorpromazine equivalents/day. Mean dose: 201 mg/day. N = 122. 2. No treatment (= crisis management, medication was only given in case of a full relapse). Duration of taper: 50% every two weeks, thus after 6 weeks only 12.5% of initial dose left, thus 42 days. Note that participants were not withdrawn after they had received crisis intervention. N = 115. Rescue medication: in the no treatment group additional antipsychotic medication could only be given in case of relapse. |
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Outcomes |
Examined Relapse: BPRS total score ‐ >10 increase, GAS < 20 reduction, deterioration Clinical Global Impression Scale CGI >7. Leaving the study early. Service use: number of participants hospitalised. Unable to use/Not included Global state: CGI (no usable data ). Mental state: BPRS, AMDP system, Paranoid Depression Scale (all no means, no SDs / no predefined outcome of interest). Functioning: Strauss and Carpenter scale, another scale validated by the study group (no usable data) Subjective well‐being (own scale ‐ no mean, no SD/no predefined outcome of interest). Adverse effects: extrapyramidal side‐effects (AIMS ‐ no SD, SAS, Dosage Record and Treatment Emergent Symptoms Scale ‐ all no means, no SDs/continuous side‐effect results were not among the predefined outcomes of interest). Concept of illness (concept of illness scale ‐ no mean, no SD). Compliance: doctors’ assessment (no predefined outcome of interest). Physiological measures: routine laboratory, ECG, EEG (no data/no predefined outcome of interest). |
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Notes | There was a third group using intermittent treatment which was not of interest for this review. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Centrally randomised by a specialised unit using an "adaptive randomisation method”. |
Allocation concealment (selection bias) | Unclear risk | Procedure not described. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Open, only key rating scales were additionally rated by a second blind assessor. |
Blinding (performance bias and detection bias) Subjective outcomes | Unclear risk | Open, only key rating scales were additionally rated by a second blind assessor. |
Blinding (performance bias and detection bias) Objective outcomes | Low risk | Open, only key rating scales were additionally rated by a second blind assessor. |
Incomplete outcome data (attrition bias) All outcomes | High risk | High two‐year discontinuation rate of 43.7%. Analysis was ITT based on Kaplan‐Meier survival curve analysis, completer analyses were presented in addition if different. A risk of bias can not be excluded given the high discontinuation rate. |
Selective reporting (reporting bias) | Low risk | No evidence for selective reporting. |
Other bias | Low risk | No clear evidence for other bias. |