What side effects are associated with this type of intervention?

Common treatments for Borderline Personality Disorder (BPD) include second-generation antipsychotics, SSRIs, and mood stabilizers. Second-generation antipsychotics can cause extrapyramidal symptoms, weight gain, and metabolic syndrome. SSRIs, while generally well-tolerated, may lead to side effects such as gastrointestinal disturbances, sexual dysfunction, and weight changes. Mood stabilizers like lithium, carbamazepine, and lamotrigine can cause tremors, increased thirst, diarrhea, and potential teratogenic effects. These treatments aim to manage symptoms but come with varying side effect profiles that need to be carefully monitored.

What prior FDA approvals exist?

As of now, there are no FDA-approved medications specifically for the treatment of Borderline Personality Disorder (BPD). Treatment typically involves a combination of psychotherapy and medications to manage symptoms such as mood instability, depression, and anxiety. Commonly used medications include antidepressants, antipsychotics, and mood stabilizers. Vafidemstat, an LSD1 inhibitor, is currently being studied for its potential efficacy in treating BPD, but it has not yet received FDA approval for this indication.

What other types of research exist?

Promising novel alternatives to Vafidemstat for BPD treatment include Asenapine, which has shown significant improvement in BPD symptomatology in an observational open-label study. Additionally, mood stabilizers and antiepileptics like Oxcarbazepine have demonstrated efficacy in treating impulsive aggression, a common symptom in BPD patients.

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Vafidemstat for Borderline Personality Disorder

Phase 2

Recruiting

Research Sponsored by Oryzon Genomics S.A.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Men and women 18-65 years of age.

Are you 18 to 65 years of age?

Must not have

Have you received esketamine in the past 3 months?

Timeline

Screening 3 weeks

Treatment 12 weeks

Follow Up 2 weeks

Summary

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.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

While the side effects of Vafidemstat are not detailed here, common side effects in trials may include nausea, headaches, dizziness, fatigue, mood changes or other physical discomforts that vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 65 years old.

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I am between 18 and 65 years old.

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I am between 18 and 65 years old.

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I am between 18 and 65 years old.

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My BMI is between 18.5 and 35.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not taken esketamine in the last 3 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ 12 weeks8 visits

Follow Up ~ 2 weeks0 visits

Screening ~ 3 weeks

Treatment ~ 12 weeks

Follow Up ~2 weeks

This trial's timeline: 3 weeks for screening, 12 weeks for treatment, and 2 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Efficacy: Beck Depression Inventory II (BDI-II)

Efficacy: Borderline Evaluation of Severity over Time (BEST)

Efficacy: Borderline Personality Disorder Checklist (BPDCL)

+6 more

Trial Design

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.

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Borderline Personality Disorder (BPD) include Dialectical Behavior Therapy (DBT), Cognitive Behavioral Therapy (CBT), and pharmacotherapy. DBT focuses on teaching patients skills to manage emotions, reduce self-destructive behaviors, and improve relationships through behavioral analysis and mindfulness techniques. CBT helps patients identify and change distorted thinking patterns and behaviors. Pharmacotherapy often targets specific symptoms such as mood instability and impulsivity using mood stabilizers or low-dose antipsychotics. Vafidemstat, a LSD1 inhibitor, is being studied for its potential to modulate gene expression and reduce neuroinflammation, which may help in managing the emotional dysregulation and impulsivity seen in BPD. Understanding these mechanisms is crucial as they address the core symptoms of BPD, potentially leading to better patient outcomes.