Rinne 2002.

Study characteristics
Methods	6‐week trial with 2 arms: fluvoxamine placebo Duration: 6 weeks, patients had to be medication‐free for at least 2 weeks before entering the trial Country: Holland Setting: outpatients
Participants	Method of recruitment of participants: "[Patients were] recruited from psychiatric outpatient clinics, from community mental health centres, and through advertisement in newspapers and on the Internet." (Rinne 2002, p. 2049) Overall sample size: 38 Diagnosis of borderline personality disorder: DSM‐IV Means of assessment: SCID‐II + a score of 110 or more on the Borderline Trait and Distress scale of a self‐report screener for personality disorders (ADP‐IV) + score of 20 or more on BPDSI Mean age: 29.2 years (SD 7.6 years; range = no information) Sex: 100% women Comorbidity: depression (28.95%), dysthymia (21.05%), generalised anxiety disorder (7.89%) and PTSD (31.58%) Inclusion criteria A score of 110 or more on the Borderline Trait and Distress Scale of a self‐report screener for personality disorders, the Assessment of DSM‐IV Personality Disorder Meet five or more of the criteria on a semi‐structured diagnostic interview, the Structured Interview for DSM‐IV Personality Disorders A score of 20 or more on a fully structured interview, the BPDSI Exclusion criteria: no information
Interventions	Experimental group Treatment name: fluvoxamine Number randomised to group: 20 Duration: 6 weeks; patients had to be medication‐free for at least 2 weeks prior to entering trial Control/comparison group Comparison name: placebo Number randomised to group: 18 Duration: 6 weeks; patients had to be medication‐free for at least 2 weeks prior to entering trial Both groups Concomitant psychotherapy: Two patients who began psychotherapy dropped out of the trial; thus, psychotherapeutic treatment was likely not to have been allowed. Concomitant pharmacotherapy: Patients had to stop taking all psychoactive drugs and be medication‐free for at least 2 weeks before entering the trial (6 weeks for fluoxetine). Proportions of participants taking standing medication during trial observation period: Patients had to be free of medication 2‐6 weeks prior to entering trial; however, no further information was stated.
Outcomes	Primary outcomes: none Secondary outcomes Anger, measured by BPDSI‐anger. Assessed at baseline and week 6 (EOT) Affective instability, measured by BPDSI‐rapid mood shifts. Assessed at baseline and week 6 (EOT) Impulsivity, measured by BPDSI‐impulsivity. Assessed at baseline and week 6 (EOT) Attrition Adverse effects: any, measured by number of participants experiencing specific adverse events (not used here as data referred to intermediate assessment, whereas post‐treatment data were not available)
Notes	Sample calculation: no information Ethics approval: no information Funding source: funded by grants from universities, authorities or research foundations Conflicts of interest: No conflicts of interest were reported. Comments from trial authors (limitations) "[...] the dose of fluvoxamine, 150 mg/day, may have been too low for the treatment of impulsive and aggressive behaviour. However, this dose was chosen because it is fairly high and is sufficient for most indications but is low enough to restrict side effects." (Rinne 2002, p. 2052) "[...] It cannot be ruled out completely that the power of the study was too small to detect smaller differences in reductions of anger and impulsivity and interactions with depression." (Rinne 2002, p. 2052) "The lack of an effect of fluvoxamine on impulsivity might also be related to the relatively low internal consistency of the impulsivity subscale of the Borderline Personality Disorder Severity Index (alpha = 0.48)." (Rinne 2002, p. 2053) Comments from review authors: This is an RCT followed by a single‐blind half cross‐over and an open treatment phase; only the first RCT phase was regarded in this review.
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 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, no information was provided on how blinding was carried out or maintained.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Comment: The trial was referred to as being double‐blind, however, no information was provided on how blinding was carried out or maintained.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Quotes: "The final study group comprised the 38 subjects eligible for participation". (Rinne 2002, p. 2049), "an intent‐to‐treat analysis was performed" (Rinne 2002, p. 2050) Comments: Of the 38 patients enrolled, 35 completed the RCT phase (19 in active drug group, 16 in placebo group). Reasons for early termination: Serious aggravation of self‐damaging behaviours: 0 in the fluvoxamine group, 2 in the placebo group Severe side effects: 1/0 Continuous outcomes based on ITT; BMDP imputation technique used for dropouts
Selective reporting (reporting bias)	Unclear risk	Comment: no protocol found
Vested Interest (funding and/or author affiliations)	High risk	Quote: "Supported by the De Geestgronden Institute of Mental Health Care, by Stichting tot Steun of Vereiniging Bennekom, by national Fund for Mental Health grant 4820, and by Solvay Pharma." (Rinne 2002, p. 2053)
Other bias	Low risk	Comment: No apparent other sources of bias found