Zanarini 2001.

Study characteristics
Methods	6‐month trial with 2 arms: olanzapine placebo Duration: 6 months Country: USA Setting: outpatient
Participants	Method of recruitment of participants: through advertisement in Boston‐area newspapers seeking women aged between 18 and 40 years, who were disturbed by moodiness, distrustfulness, impulsivity, and painful and difficult relationships Overall sample size: 28 Diagnosis of borderline personality disorder: DSM‐IV Means of assessment: DIB‐R Mean age: 26.7 years (SD = no information; range = no information) Sex: 100% women Comorbidity: no information Inclusion criteria: meeting both DIB‐R and DSM‐IV criteria for BPD and not meeting current criteria for major depression Exclusion criteria Actively abusing alcohol or drugs Acutely suicidal Current or lifetime schizophrenia Schizoaffective disorder Bipolar disorder Medically ill Seizure disorder Pregnant or planning to become pregnant Breastfeeding Not using reliable forms of contraception Having been treated with olanzapine Being prescribed any psychotropic medication that patients thought was helpful
Interventions	Experimental group Treatment name: olanzapine Number randomised to group: 19 Duration: 6 months Control/comparison group Comparison name: placebo Number randomised to group: 9 Duration: 6 months Both groups Concomitant psychotherapy: not specified Concomitant pharmacotherapy: No other psychotropic medication was allowed. Proportions of participants taking standing medication during trial observation period: Patients currently prescribed any psychotropic medication that they thought was helping to alleviate troublesome symptoms were excluded. No further information provided
Outcomes	Primary outcomes Mental health status, measured by GAF. Assessed at baseline and weeks 1, 2, 3 and 4, then monthly for 5 months Secondary outcomes Anger, measured by SCL‐90‐HOS. Assessed at baseline and weeks 1, 2, 3 and 4, then monthly for 5 months Interpersonal problems, measured by SCL‐90‐INT. Assessed at baseline and weeks 1, 2, 3 and 4, then monthly for 5 months Dissociative symptoms, measured by DES. Assessed at baseline and weeks 1, 2, 3 and 4, then monthly for 5 months Psychotic symptoms, measured by SCL‐90‐PAR, SCL‐90‐PS and PANSS. Assessed at baseline and weeks 1, 2, 3 and 4, then monthly for 5 months Depression, measured by SCL‐90‐DEP and Ham‐D. Assessed at baseline and weeks 1, 2, 3 and 4, then monthly for 5 months Attrition Adverse effects, measured by weight, Simpson‐Angus Scale, BARS, AIMS and structured questionnaire. Assessed at baseline and week 1,2,3 and 4, then monthly for 5 months
Notes	Sample calculation: no information Ethics approval: no information Funding source: funded or partially funded by pharmaceutical industry Conflicts of interest: No conflicts of interest were reported besides partial funding from the pharmaceutical industry. Comments from trial authors (limitations) "the sample size was small". (Zanarini 2001, p. 853) "the sample consisted only of women with BPD. Whether these results would also apply to men meeting criteria for BPD is unknown". (Zanarini 2001, p. 853) "the sample was composed of moderately ill outpatients who were not suffering from a concurrent major depressive episode, abusing substances or taking concurrent medications. It is unknown if similar results would be obtained in a more severely impaired sample of borderline patients, particularly those who are inpatients at the time of their participation in a controlled trial of olanzapine begins." (Zanarini 2001, p. 853) " only 1 participant in the placebo condition and 8 participants in the olanzapine completed the entire 6‐month trial." (Zanarini 2001, p. 853)
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "random number sequence" (Zanarini 2001, p. 850)
Allocation concealment (selection bias)	Unclear risk	Comment: There was no information on how sequence allocation was concealed to permit a judgement of low or high risk of bias.
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote: "Tablets were supplied in numbered bottles containing drug or placebo as determined by a random number sequence." (Zanarini 2001, p. 850) Quote: "Each tablet contained either 2.5 mg of olanzapine or matching inert placebo. [...] Both subjects and clinicians were blinded to olanzapine/placebo assignment. The blind was broken after the acquisition of all endpoint data for all subjects." (Zanarini 2001, p. 850)
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	Unclear risk	Quote: "Thirty subjects completed all aspects of pre‐randomization assessment. However, 2 of these subjects were excluded [...] because it was determined that they were responding well to a selective serotonin reuptake inhibitor. Twenty‐eight subjects entered the trial and were randomly assigned [...] All [...] completed at least 2 post‐baseline visits and were included in all subsequent analyses." (Zanarini 2001, p. 851) Comment: Of the 28 patients enrolled, 9 completed treatment (8 in olanzapine group, 1 in placebo group) Reasons for early termination: Sedation: 1 in olanzapine group, 0 in placebo group Increased anxiety or depression: 3/2 Perceived weight gain: 2/0 Lost to follow‐up: 5/6 Continuous outcomes based on ITT sample (LOCF) Comment: high dropout rate overall, but adequately addressed
Selective reporting (reporting bias)	High risk	Quote: "Due to the small number of subjects, results pertaining to secondary outcome measures will not be reported." (Zanarini 2001, p. 851)
Vested Interest (funding and/or author affiliations)	High risk	Quote: "Supported, in part, by a grant from Eli Lilly" (Zanarini 2001, p. 849)
Other bias	Low risk	Comment: no apparent other sources of bias found