Montgomery 1982b.
Study characteristics | ||
Methods | 38 participants; 6‐month trial with 2 arms:
Duration of trial: 24 weeks Country: UK Setting: outpatient |
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Participants |
Methods of recruitment of patients: "[...] endogenously depressed patients who were taking part in a comparative antidepressant efficacy study of zimelidine and maprotiline were recruited". (Montgomery 1982a, p. 292) Overall sample size: 38 Diagnosis of borderline personality disorder: DSM‐III Means of assessment: clinical interview Mean age: 35.65 years (SD = no information; range = no information) Sex: 68.42% women Comorbidity: no information Inclusion criteria
Exclusion criteria
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Interventions |
Experimental group
Treatment name: mianserin
Number randomised to group: 29
Duration: 6 months Control/comparison group Comparison name: placebo Number randomised to group: 29 Duration: 6 months Both groups Concomitant psychotherapy: Patients were followed up in a clinic, with back‐up from social workers, community nurses and a crisis intervention team. Concomitant pharmacotherapy: no information Proportions of participants taking standing medication during trial observation period: no information |
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Outcomes |
Primary outcomes: suicidal behaviour, measured by the number of participants in each group with/without act of self‐harm within the 6 months of treatment. Assessed at week 4, 8, 12, 16, 20 and 24 (EOT) Secondary outcomes: attrition in terms of participants lost after randomisation |
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Notes |
Sample calculation: no information Ethics approval: no information Funding source: unclear funding Conflicts of interest: No conflicts of interest were reported. Comments from trial authors (limitations): none mentioned |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Comment: insufficient information on methods used to generate random sequence to permit a judgement of low or high risk of bias |
Allocation concealment (selection bias) | Unclear risk | Comment: no information provided on allocation concealment to permit a judgement of low or high risk of bias |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Comment: The trial was referred to as being double‐blind, however, insufficient information was given on how blinding of participants and personnel was carried out (packaging of trial medication etc.) and maintained, to permit a judgement of low or high risk of bias. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: The trial was referred to as being double‐blind, however, insufficient information was given on how blinding of outcome assessors was carried out and maintained, to permit a judgement of low or high risk of bias. |
Incomplete outcome data (attrition bias) All outcomes | Low risk |
Comment: dichotomous outcomes used here were based on the ITT sample; patients who had dropped out were imputed as having the negative outcome. High dropout rate (20 out of 58; Montgomery 1983, p. 787), but reasons not specified, nor to which treatment group the lost patients belonged. Therefore, dropouts could not be imputed in categorical outcomes as having the negative outcome. |
Selective reporting (reporting bias) | Unclear risk | Comment: no protocol found |
Vested Interest (funding and/or author affiliations) | Unclear risk | Comment: no details about funding/sponsoring provided |
Other bias | Low risk | Comment: no indication of other bias |