Introduction
Methods
Results of the Search
RCTs | Participants | Interventional drug | Comparison treatment | Observation period | Outcomes | Effects | |
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Antidepressants | |||||||
NCT00834834 [18] | n = 84 participants with BPD (DSM-IV), 8.3% men, suicide attempt within past 2 months, additional suicide attempt(s) or self-injury episode in past 12 months | Fluoxetine (up to 40 mg/day) + clinical management, switching to citalopram (up to 60 mg/day) if necessary | DBT | 6 months | Suicidal and suicide-related behaviour, serious and non-serious AE | Significantly more suicide attempts in fluoxetine group (RR 2.87, 95% CI 1.15, 7.20) | |
NCT00533117 [19] | n = 75 participants with BPD, 22.7% men, at least one suicide attempt or self-mutilation episode 12 months prior to study entry, continued urges to self-mutilate or attempt suicide | Fluoxetine (up to 80 mg/day) + DBT or + SP | Placebo + DBT or + SP | 12 months | Suicidal ideation, suicide attempts, and self-mutilation | Data available only for serious AE (including suicide attempts), difference between groups with active drug and placebo n.s. | |
Antipsychotics | |||||||
Bozzatello et al. 2017 [11] | n = 51 outpatients with BPD | Olanzapine (5–10 mg/day) | Asenapine (5–10 mg/day) | 12 weeks | Clinical severity, depression, anxiety, psychosocial functioning, BPD symptoms, BPD severity, impulsiveness, aggression, self-harm, and AE | Olanzapine superior: dissociation/paranoid ideation (η2 = 0.21, p = 0.012), asenapine superior: affective instability (η2 = 0.53, p = 0.001) | |
Black 2014 [16]: new final data posted at ClinicalTrials.gov [17], additional data published in paper by Lee et al. [14] | n = 97 outpatients with BPD, 29.5% men (common comorbidities were excluded: MDD, PTSD, panic disorder, obsessive-compulsive disorder, substance dependence or abuse (other than alcohol/nicotine) | Quetiapine 150 mg/day(n = 33); quetiapine 300 mg/day (n = 33) | Placebo (n = 29) | 8 weeks | BPD severity, psychosocial functioning, impulsiveness, aggression, mania, depression, general psychopathology, and AD | Significant effects for 150 mg/day as compared with placebo:BPD severity self-rated (BEST), SMD − 0.67, p = 0.01; BPD severity interviewer-rated (Zan-BPD): SMD − 0.55, p = 0.03), psychosocial functioning (SDS), SMD − 1.36, p < 0.0001; aggression (OAS-M) SMD − 0.65, p = .01; non-serious adverse events, RR 1.34, p = .05) | Significant effects for 300 mg/day as compared with placebo, BPD severity self-rated (BEST), SMD − 0.57, p = .02; psychosocial functioning (SDS), SMD, p < .00001; aggression (OAS-M), SMD − 0.60, p = .02; mania (YMS), SMD − 1.21, p < .0001; non-serious AE, RR 1.39, p = .02 |
Lee et al. 2016 [14]: SCL-90-R subscales | Significant effects for 150 mg/day as compared with placebo,interpersonal sensitivity (d = − 0.58, p = 0.038, depression d = − 0.87, p = 0.007), hostility (d = − 0.71, p = 0.017) | Significant effects for 150 mg/day as compared with placebo,interpersonal sensitivity (d = − 0.80, p = 0.05), depression (d = − 0.94, p = 0.04), hostility (d = − 0.68, p = 0.023), phobic anxiety (d = −0.66, p = 0.023), SCL-90-R total (d = − 0.62, p = 0.033) | |||||
Mood stabiliser | |||||||
n = 195 participants with BPD (24.6% men) | Lamotrigine (up to 200 mg/day) | Placebo | 52 weeks | BPD symptoms, self-harm, social functioning, drug and alcohol use, health-related quality of life, AE, and costs | No significant difference was observed for any outcome | ||
Other substance classes | |||||||
Kulkarni 2018 [13] | n = 18 participants with BPD (13.8% men) | Memantine (anti-dementia drug; up to 20 mg/day) as adjunct to ongoing psychotherapy and/or medication | Placebo | 8 weeks | BPD symptoms, AEs | Significantly higher rate of change in BPD severity (latent growth curve analysis; b = 7.30, p = 0.02) reported by study authors; between-group effects do not indicate a significant difference SMD 0.37 (− 0.32, 1.06) | |
NCT01212588 [20] | n = 22 participants with BPD (13.5% men) | Mifepristone (3 × 200 mg/day) | Placebo | 7 days | BPD pathology, general psychopathology, psychotic symptoms, and AE | No significant effects for mifepristone, instead consistent trend of better outcomes in placebo group, including one sig. effect indicating less identity disturbance in control group (SMD 0.97, 95% CI 0.08 to 1.87) | |
NCT00539188 [21] | n = 6 participants with BPD (33% men) | N-Acetylcysteine3000 mg PO (1200 mg a.m., 1800 mg p.m.), | Placebo | 6 weeks | Self-harm | Study was withdrawn due to poor subject compliance. |
Antidepressants
Recently Published RCT Data
Unpublished RCTs
Ongoing RCTs
Critical Judgement of Current Evidence
Antipsychotics
Recently Published RCT Data
Ongoing Studies
Trial registration number | Participants | Sponsor | Registration date (month/year) | Interventional drug | Comparison treatment | Observation period | Clinical outcomes |
---|---|---|---|---|---|---|---|
Antipsychotics | |||||||
ACTRN12616001192471 [35] | BPD + auditory verbal hallucinations, aged 15 to 25 years | N/a | 08/2018 | Aripiprazole (up to 30 mg/day) | Placebo | 12 weeks | Severity of auditory verbal hallucinations, BPD severity, depression, anxiety, psychotic symptoms, and psychosocial functioning |
ISRCTN18352058 [34] | Inpatients with BPD without adequate clinical response to antipsychotic medication other than clozapine | University | 03/2019 | Clozapine (up to 400 mg/day) | Placebo | 6 months | BPD severity, psychotic symptoms, suicidal behaviour, aggression, health-related quality of life, side effects, medication adherence, and service use |
NCT03418675 [32] | BPD | University, industry | 02/2018 | Brexpiprazole (up to 2 mg/day) | Placebo | 12 weeks | BPD severity, aggression, impulsiveness, suicidality, anxiety, depression, impairment, quality of life, and mania |
NCT04100096 [33] | BPD | Industry | 09/2019 | Brexpiprazole (up to 3 mg/day | Placebo | 12 weeks | BPD severity, global clinical severity |
Explanatory trials miscellaneous | |||||||
NCT03395314 [45] | BPD | University | 01/2018 | Ketamine i.v. 0.5 mg/kg over 40 min | Placebo (midazolam, 0.04 mg/kg over 40 min) | Single application, observation period 4 weeks | BPD severity, suicidality, depression, anxiety, psychosocial functioning, and psychotic symptoms |
NCT02728778 [46] | BPD | University | 04/2016 | Botulinum toxin A Single administration of incobotulinumtoxin A into the forehead (glabellar region); 34 U in five injection sites | Acupuncture into the forehead | Single application, observation period 16 weeks | BPD pathology, depression |