Methods | Design: placebo-controlled parallel trial. |
Participants | Participants: outpatients with repeated suicidal attempts but without major depression Sex: 37 male; 54 female (data not extractable for any AsPD subgroup; see note 1) Age: mean 34.1 (SD 11.6) and 37.1 (SD 13.0) years (data not extractable for any AsPD subgroup; see note 1) Unit of allocation: individual participant. Number randomised: 91 (paroxetine, n = 46; placebo, n = 44) (see note 1). Number completing: at 8 weeks (paroxetine, n = 28; placebo, n = 30); at 52 weeks (paroxetine, n = 11; placebo, n = 8) (see note 1) Setting: outpatient; 2 sites; Netherlands (Rotterdam, Leiden). Inclusion criteria: at least one previous suicide attempt; aged 18 yrs or older Exclusion criteria: major affective disorder; psychotic disorder; currently taking antidepressant or antipsychotic medication; organic mental disorder; dependency on alcohol or substances; using prohibited medication; serious physical disease; unable to co-operate Ethnicity: not reported. |
Interventions | Two conditions: paroxetine/ placebo.
In addition to medication, supportive psychotherapy offered weekly to fortnightly to all participants Duration of intervention: up to 52 weeks. Duration of trial: up to 52 weeks. Length of follow up: participants were not followed up beyond the end of the intervention period Dose adjustment: initial placebo washout period of 2 weeks; then 20 mg/day paroxetine for one week followed by a fixed dose of 40 mg/day for up to 52 weeks (or matching placebo) |
Outcomes |
Primary outcomes
none. Secondary outcomes Leaving the study early: Anger: STAXI scores. Other outcomes subsequent suicide attempts; depression (Beck Depression Inventory; self report); hopelessness (Beck Hopelessness Scale, self-report) |
Notes | 1. study may have recruited a subgroup with AsPD as 74 participants had DSM-III-R Cluster B personality disorder, although this is unclear. No data extractable on any AsPD subgroup. Awaiting clarification from investigators |
RCT: randomised controlled trial