Stanley 2017.

Study characteristics
Methods	12‐month trial with 4 arms Dialectical behavior therapy (DBT) + fluoxetine DBT + placebo Supportive therapy + fluoxetine supportive therapy + placebo Duration of trial: 12 months Country: USA Setting: inpatient
Participants	Method of recruitment of participants: recruited from emergency departments, clinician referrals and advertisements. Recruitment period ended 6 months prior to study end date. Sample size: 86 Diagnosis of borderline personality disorder: not stated Means of assessment: not stated Age: not stated Sex: not stated Comorbidity: not stated Inclusion criteria Meets criteria for diagnosis of borderline personality disorder History of at least 1 suicide attempt or self‐mutilation episode 12 months prior to study entry Experiences continued urges to self‐mutilate or attempt suicide Stable living situation Use of effective birth control if sexually active Clinically stable enough to tolerate placebo condition Not participating in other forms of treatment during the study Exclusion criteria Any current organic mental syndromes, lifetime schizophrenic or bipolar disorders, psychotic disorders, or mental retardation Inability to complete psychiatric interview due to lack of cooperation or lack of comprehension Unable to tolerate fluoxetine or DBT Currently receiving treatment for an acute medical illness or other debilitating problem, including substance abuse or anorexia nervosa History of major depression lasting more than 3 months Current Hamilton depression score above 22 and not receiving treatment Pregnant or breastfeeding
Interventions	Experimental group Treatment name: DBT + fluoxetine Number randomised to group: 18 Duration: 12 months Control/comparison group 1 Comparison name: DBT + placebo Number randomised to group: 19 Duration: 12 months Control/comparison group 2 Comparison name: supportive therapy + fluoxetine Number randomised to group: 20 Duration: 12 months Control/comparison group 3 Comparison name: supportive therapy + placebo Number randomised to group: 18 Duration: 12 months All groups Concomitant psychotherapy: not stated Concomitant pharmacotherapy: all participants were washed out of psychotropic medications and received fluoxetine or placebo, depending on randomisation (50% of each group received fluoxetine or placebo). Benzodiazapines were permitted for sleep. Proportions of participants taking standing psychotropic medication during trial observation period: 50% of each group were taking fluoxetine.
Outcomes	Primary Suicide‐related outcomes, assessed by total counts of attempted suicide attempts over the course of the 12‐month treatment period (sum of 6, bimonthly assessments during the treatment phase) Secondary Attrition, in terms of patients lost after randomisation in each group Adverse effects, measured by spontaneous reporting
Notes	Sample size calculation: not stated Ethics approval: not stated Comments from review authors: Data available at clinicaltrials.gov/ct2/show/results/NCT00533117
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Comment: no clear information on randomisation method was provided
Allocation concealment (selection bias)	Unclear risk	Comment: no clear information on allocation concealment was provided
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Comment: outcome assessors were masked to treatment allocation
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Comment: dropout rates were even across groups, total rates were around ¼ of participants; no information provided on ITT, but all randomised participants were analysed
Selective reporting (reporting bias)	Low risk	Comment: NCT00533117: no apparent bias
Other bias	Unclear risk	Treatment adherence Comment: adherence not stated Attention bias Comment: equal treatment in four groups Allegiance bias Comment: nothing found