210 Participants Needed

Vafidemstat for Borderline Personality Disorder

Recruiting at 24 trial locations
VG
MR
Overseen ByMichael Ropacki, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Trial Phase: Phase 2
Sponsor: Oryzon Genomics S.A.
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

This trial is testing a new medication called vafidemstat to see if it can help adults with borderline personality disorder. The study will check if the medication is safe and effective over several weeks.

Will I have to stop taking my current medications?

The trial requires that you maintain your current medication regimen throughout the study and not start any new prohibited medications. You should inform your study physician of any changes in your medications during the trial.

What data supports the effectiveness of the drug Vafidemstat for treating Borderline Personality Disorder?

Research on similar drugs, like antipsychotics, shows they can help with impulsivity, aggression, and interpersonal relationships in Borderline Personality Disorder. This suggests that Vafidemstat, which may have similar properties, could also be effective.12345

How does the drug Vafidemstat differ from other treatments for borderline personality disorder?

Vafidemstat is unique because it is being specifically studied for its effects on borderline personality disorder, whereas other treatments like antipsychotics, antidepressants, and mood stabilizers are often used based on their effects on related symptoms rather than the disorder itself. This trial is exploring its potential as a novel option, distinct from existing medications that target symptoms like mood instability and impulsivity.12367

Research Team

MR

Michael Ropacki, MD

Principal Investigator

Oryzon Genomics

Eligibility Criteria

This trial is for adults aged 18-65 with Borderline Personality Disorder (BPD), confirmed by specific criteria and interviews. Participants should have a BMI between 18.5 and 35, indicating a healthy weight range. Those who've attempted suicide or taken esketamine in the past three months cannot join.

Inclusion Criteria

You have a healthy weight that is not too low or too high, with a BMI between 18.5 and 35.
I am between 18 and 65 years old.
I am between 18 and 65 years old.
See 2 more

Exclusion Criteria

I have not used esketamine in the last 3 months.
I am between 18 and 65 years old.
Your Body Mass Index (BMI) is 18.5 to 35.0
See 4 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive vafidemstat or placebo for 14 weeks in a double-blind, randomized, placebo-controlled setting

14 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Placebo
  • Vafidemstat
Trial OverviewThe PORTICO study is testing Vafidemstat's effectiveness and safety in treating BPD compared to a placebo. This Phase IIb trial will randomly assign participants to either receive Vafidemstat or an inactive substance, without choosing which one they get.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: vafidemstat 1.2mgExperimental Treatment1 Intervention
Vafidemstat is administered as capsules.
Group II: placeboPlacebo Group1 Intervention
Placebo is administered as capsules.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Oryzon Genomics S.A.

Lead Sponsor

Trials
5
Recruited
350+

References

Personality trait dimensions and the pharmacological treatment of borderline personality disorder. [2018]
Evaluation of naltrexone for dissociative symptoms in borderline personality disorder. [2013]
Treatment of depression and borderline personality disorder with 1 Hz repetitive transcranial magnetic stimulation of the orbitofrontal cortex - A pilot study. [2023]
Neurobiological and clinical effect of metacognitive interpersonal therapy vs structured clinical model: study protocol for a randomized controlled trial. [2020]
Efficacy of pharmacotherapy against core traits of borderline personality disorder: meta-analysis of randomized controlled trials. [2022]
omega-3 Fatty acid treatment of women with borderline personality disorder: a double-blind, placebo-controlled pilot study. [2016]
Ziprasidone in the treatment of borderline personality disorder: a double-blind, placebo-controlled, randomized study. [2022]