Zanarini 2004.

Study characteristics
Methods	8‐week trial with 3 arms: fluoxetine olanzapine fluoxetine + olanzapine Duration: 8 weeks Country: USA Setting: outpatient
Participants	Method of recruitment of participants: "Recruitment [...] was accomplished primarily through advertisement in Boston, Mass. area newspapers." (Zanarini 2004, p. 904) Overall sample size: 45 Diagnosis of borderline personality disorder: DSM‐IV Means of assessment: DIB‐R Mean age: 23 years (SD 5.7; range = no information) Sex: 100% women Comorbidity: Current major depression, current or lifetime schizophrenia, schizoaffective disorder and bipolar disorder were exclusion criteria. In terms of Axis I disorders, 93.3% had a history of a mood disorder, 51.1% had a history of a substance use disorder, 48.9% had a history of an anxiety disorder and 44.4% had a history of an eating disorder. Inclusion criteria Meeting both DIB‐R and DSM‐IV criteria for borderline personality disorder Women Aged 18 to 40 years Exclusion criteria Current major depression Current or lifetime schizophrenia Schizoaffective disorder Bipolar disorder
Interventions	Experimental group Treatment name: fluoxetine Number randomised to group: 14 Duration: 8 weeks Comparison group 1 Treatment name: olanzapine Number randomised to group: 16 Duration: 8 weeks Comparison group 2 Treatment name: fluoxetine + olanzapine Number randomised to group: 15 Duration: 8 weeks All groups Concomitant psychotherapy: not specified Concomitant pharmacotherapy: Current prescription to any psychotropic medication was an exclusion criterion. No other information provided Proportions of participants taking standing medication during trial observation period: no information
Outcomes	Primary outcomes: none Secondary outcomes Impulsivity, measured by OAS‐M total. Assessed at baseline and every week for 8 weeks (EOT) Depression, measured by MADRS. Assessed at baseline and every week for 8 weeks (EOT) Attrition Adverse effects, measured by weight at baseline and EOT, and by the Simpson‐Angus Rating Scale, BARS, AIMS and structured questionnaire. Assessed at baseline and every week for 8 weeks (EOT)
Notes	Sample calculation: no information Ethics approval: yes Funding source: funded or partially funded by pharmaceutical industry Comments from trial authors (limitations) [...] there was no placebo group for comparison, particularly for OFC, which has never been compared with placebo in a study of borderline personality disorder." (Zanarini 2004, p. 907) "[...] the study was limited to women with borderline personality disorder, and there is no way of knowing if men with borderline personality disorder would have the same response pattern as the women in this study." (Zanarini 2004, p. 907)
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: insufficient information to permit judgement of high or low risk of bias
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote: "Dose was adjusted by an unblinded psychiatrist according to perceived response and side effects. Both subjects and raters were blinded to study assignment. The blind was broken after acquisition of all endpoint data for all subjects." (Zanarini 2004, p. 904)
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote: "Dose was adjusted by an unblinded psychiatrist according to perceived response and side effects. Both subjects and raters were blinded to study assignment. The blind was broken after acquisition of all endpoint data for all subjects." (Zanarini 2004, p. 904)
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Comments: Reasons for dropout specified (Zanarini 2004 p. 905), but outcome data were only reported for completers. Of the 45 patients enrolled, 42 completed treatment (13 in fluoxetine group, 16 in olanzapine group, 13 in fluoxetine + olanzapine group) Reasons for early termination: Onset of a number of psychosocial stressors culminating in a suicide gesture: 1/0/0 Dizziness and headaches: 0/0/1 Lost to follow‐up: 0/0/1
Selective reporting (reporting bias)	Unclear risk	Comment: no protocol found
Vested Interest (funding and/or author affiliations)	High risk	Quote: "Supported by a grant from Eli Lilly, Indianapolis, Ind." (Zanarini 2004, p. 903)
Other bias	Low risk	Comment: no apparent other sources of bias found