Nickel 2006.

Study characteristics
Methods	8‐week trial with 2 arms: aripiprazole placebo Duration of trial: 8 weeks Country: Germany Setting: outpatient
Participants	Method of recruitment of participants: Participants were recruited through advertisements. Overall sample size: 52 Diagnosis of borderline personality disorder: DSM‐IV Means of assessment: SCID‐II Mean age: 21.65 years (SD 3.4; range = no information) Sex: 82.69% women, 17.3% men Comorbidity: Comorbidity included depressive disorders, anxiety disorders, obsessive‐compulsive disorders and somatoform disorders. Inclusion criteria: meeting criteria for borderline personality disorder Exclusion criteria Current suicidal ideation Schizophrenia Current use of aripiprazole or another psychotropic medication Current psychotherapy Pregnancy, planned pregnancy or sexual activity without contraception Severe somatic illness
Interventions	Experimental group Treatment name: aripiprazole Number randomised to group: 26 Duration: 8 weeks Control/comparison group Comparison name: placebo Number randomised to group: 26 Duration: 8 weeks Both groups Concomitant psychotherapy: not allowed Concomitant pharmacotherapy: not allowed Proportions of participants taking standing medication during trial observation period: no information; however, concomitant medication was not allowed.
Outcomes	Primary outcomes Self‐mutilating behaviour, measured by the number of patients with/without self‐injury during the 8‐week treatment Psychosocial functioning, measured by SCL‐90‐R GSI. Assessed at baseline and every week for 8 weeks (EOT) Secondary outcomes Anger, measured by SCL‐90‐R‐HOS and STAXI‐trait anger subscale. Assessed at baseline and every week for 8 weeks (EOT) Impulsivity, measured by STAXI‐anger out subscale. Assessed at baseline and every week for 8 weeks (EOT) Interpersonal problems, measured by SCL‐90‐R‐INT. Assessed at baseline and every week for 8 weeks (EOT) Psychotic symptoms, measured by SCL‐90‐R‐PAR and SCL‐90‐R‐PSY. Assessed at baseline and every week for 8 weeks (EOT) Depression, measured by SCL‐90‐R‐DEP and Ham‐D. Assessed at baseline and every week for 8 weeks (EOT) Adverse effects, measured by a non‐validated questionnaire, serious side effects and suicidal acts. Assessed every week for 8 weeks (EOT)
Notes	Sample calculation: no information Ethics approval: Yes, "The study was planned and conducted in accordance with the Declaration of Helsinki and ethical laws pertaining to the medical profession, and its design was approved by the clinic’s ethics committee". (Nickel 2006, p. 835) Funding source: no funding received Conflicts of interest: No conflicts of interest were reported Comments from trial authors (limitations) "Despite a valid power analysis, the group was small". (Nickel 2006, p. 836) "The length of this trial was only 8 weeks, which possibly reduced the failure rate". (Nickel 2006, p. 836) "The effects of aripiprazole on the fourth dimension—disturbed relationships—were not evaluated". (Nickel 2006, p. 837) "the Zanarini Rating Scale for Borderline Personality Disorder, a new clinician‐rated outcome measure specifically designed for borderline personality disorder, was not available in the German language when we began the study." (Nickel 2006, p. 837)
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Comment: The article mentioned that the trial was randomised, however, there was insufficient information on how the randomisation procedure was carried out to permit a judgement of low or high risk of bias.
Allocation concealment (selection bias)	Unclear risk	Quote: "The random assignment was carried out confidentially by the clinic administration and arranged so that the same number of patients would be treated with the active drug (N = 26, 21 women and 5 men) as with a placebo (N = 26, 22 women and 4 men)". (Nickel 2006, p. 835) Comment: Allocation sequence appeared to have been confidential, however, there was insufficient information on how this confidentiality was maintained to permit a judgement of low or high risk of bias.
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote: "the subjects received medication in a blinded manner, […] The dosage remained constant. Tablets were supplied in numbered boxes. Both the subjects and the clinicians were blinded regarding the assignment of aripiprazole or placebo." (Nickel 2006, p. 835)
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Quote: "the subjects received medication in a blinded manner, […] The dosage remained constant. Tablets were supplied in numbered boxes. Both the subjects and the clinicians were blinded regarding the assignment of aripiprazole or placebo." (Nickel 2006, p. 835) Comment: Unclear if clinicians were also outcome assessors, therefore insufficient information to permit judgement of low or high risk of bias
Incomplete outcome data (attrition bias) All outcomes	Low risk	Quotes: "Five subjects who missed more than two weekly evaluations dropped out." (Nickel 2006, p. 835) "according to the intent‐to‐treat principle performed with the last‐observation‐carried‐forward" (Nickel 2007, p. 1025) Comments: Of the 52 patients enrolled, 47 completed treatment. Reasons for dropout not further specified. Reasons for early termination: Failed to appear more than twice for weekly evaluation, no further reasons given: 5 participants, no further details Continuous outcomes based on ITT sample (LOCF); dichotomous outcomes based on ITT sample
Selective reporting (reporting bias)	Unclear risk	Comment: no protocol found
Vested Interest (funding and/or author affiliations)	Unclear risk	Quote: "The study was planned and conducted in accordance with the Declaration of Helsinki and ethical laws pertaining to the medical profession, and its design was approved by the clinic's ethics committee. The study was conducted independently of any institutional influence and was not funded." (Nickel 2006, p. 835)
Other bias	Low risk	Comment: No apparent other sources of bias found