So far, 17 clinical trials on BPD have failed. Methodological challenges include the lack of a ‘gold standard’ measure, uncertain but high placebo rate, large sample sizes, difficult and non-adherent patient population, endpoint timing challenges, and large percentages of BPD patients receiving psychotherapy [2]. PORTICO is the first real-world clinical trial designed to overcome many of these methodological challenges. It is designed as a double-blind, randomised, placebo-controlled, adaptive, 14-week phase 2b trial to evaluate the efficacy and safety of vafidemstat in adult BPD patients.
Vafidemstat is a selective inhibitor of the epigenetic target LSD1, modulating aggression and sociability. It represents a novel epigenetic approach for the treatment of BPD. It is this novel approach that is supposed to facilitate enrollment of a real-world BPD population, allowing common comorbidities, psychotherapy, and concomitant medications that would normally be exclusion criteria. It may also aid treatment adherence, decrease dropout rate, and result in cleaner data.
A maximum of 156 participants will be randomised 1:1 to 1.2 mg vafidemstat or placebo. About 124 of them are expected to complete the study, as about 20% of patients are projected to drop out of the trial. PORTICO will involve 9 study visits and a blinded protocol to reduce the risk of bias in the assessment of the study endpoints. The primary objectives of the trial are a reduction of aggression and agitation plus an overall improvement of BPD. Primary endpoints include the Clinician’s Global Impression-Severity focused on agitation and aggression (CGI-S A/A), and the Borderline Personality Disorder Checklist (BPDCL).
- Gutiérrez S, et al. PORTICO – Phase IIb trial evaluating vafidemstat, an epigenetic therapeutic approach, for the treatment of Borderline Personality Disorder. P.1004, ECNP 2021 Congress, 2–5 October.
- Ropacki MT. ISCTM Autumn Conference 2020, 21–25 September.
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Table of Contents: ECNP 2021
Featured articles
Anxiety and Stress
Anxiolytic activity of a novel orexin-1 receptor antagonist
Autism
Finding biomarkers for improved patient stratification
Behavioural Disorders
Sex similarities and differences in the neurobiology of aggression
Risky driving and lifestyle may have a common psychobiological basis
Cannabidiol for cannabis cessation shows positive results
Somatic comorbidities of ADHD: epidemiological and genetic data
Novel approaches to understanding the social brain
COVID-19
Alcohol consumption during lockdown
Post-COVID-19 depression responds well to SSRIs
Impact of COVID-19 on patients with psychotic disorders
Mood Disorders
Depression and brain structures associations across a lifespan
BDNF/TrkB pathway promising alternative for new antidepressants
Zuranolone reduces symptoms of major depression
Vortioxetine effectively reduces symptoms of depression and anxiety
Esketamine outperforms real-world management for treatment-resistant depression: preliminary results
Smartphone interventions in bipolar disorder: a position paper
Connecting, challenging, and empowering youth through their smartphone
Personality Disorders
Evaluating vafidemstat for the treatment of borderline personality disorder
Deep brain stimulation effective in the treatment of refractory OCD
Psychotic Disorders
Why antipsychotics cause weight gain
Roluperidone improves negative symptoms in schizophrenia
Other
Brain Prize Lecture: Prof. Jes Olesen on migraine
Laxative may improve cognitive performance
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