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. 2022 Nov 14;2022(11):CD012956. doi: 10.1002/14651858.CD012956.pub2

Montgomery 1982b.

Study characteristics
Methods 38 participants; 6‐month trial with 2 arms:
  1. mianserin

  2. placebo


Duration of trial: 24 weeks
Country: UK
Setting: outpatient
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
  1. Patients admitted following a suicidal act

  2. Having a history of 2 or more previous documented suicidal acts

  3. More than 75% BPD (23 out of 30* by DSM‐III and clinical interview)


Exclusion criteria
  1. Overt schizophrenia or depression

  2. Organic illness

Interventions Experimental groupTreatment name: mianserin
Number randomised to group: 29
Duration: 6 months
Control/comparison groupComparison name: placebo
Number randomised to group: 29
Duration: 6 months
Both groupsConcomitant 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
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
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
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