Actively Recruiting

Phase 2
Age: 18Years - 65Years
All Genders
ID02097706

A Randomised Double-blind Placebo Controlled Investigation of the Efficacy of a Novel Drug as an Adjunct Treatment in Patients With Borderline Personality Disorder

Led by The Alfred · Updated on 2025-08-15

150

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Borderline Personality Disorder (BPD) is a common and serious psychiatric condition that affects millions worldwide, leading to significant difficulties in daily life and high rates of suicidal thoughts and actions. Young women are especially at risk, with BPD being diagnosed three times more often in women than men. The causes of BPD are complex, involving both biological and environmental factors such as abuse and family issues, which contribute to emotional and behavioral challenges. Currently, no medications are specifically approved to treat BPD effectively, and many patients struggle with existing treatments due to side effects or lack of response. Researchers are evaluating a novel drug that blocks a brain receptor called NMDA, which has been approved for Alzheimer's disease and is being studied for other psychiatric conditions. In this trial, 150 adults with BPD will be randomly assigned to receive either the study drug at a dose of 20 mg daily or a placebo, in addition to their current antipsychotic treatment, for 12 weeks. The trial is double-blind, meaning neither participants nor researchers know who receives the drug or placebo, to fairly assess the drug's effects. Participants will be closely monitored throughout the study with regular assessments of their borderline symptoms and cognitive function using specific rating scales at multiple time points over 12 weeks. Safety and tolerability will also be observed. This thorough evaluation aims to determine whether adding this novel drug can improve symptoms and functioning in people living with BPD during and at the end of the treatment period.

CONDITIONS

Brief Title

A Novel Drug for Borderline Personality Disorder

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Men and women aged between 18 and 65 years
  • Current diagnosis of Borderline Personality Disorder or a score of 8 or higher on the Diagnostic Interview for Borderline patients or a score of 15 or higher on the Zanarini Rating Scale for Borderline Personality Disorder
  • Able to read and write English proficiently
Not Eligible

You will not qualify if you...

  • Acute delirium or severe head injury
  • Epilepsy, seizure disorder, history of seizures (excluding febrile convulsions), or risk factors for epilepsy
  • Significant liver, kidney, blood, or heart disease
  • Current use of NMDA antagonists, L-dopa, dopamine agonists, or anticholinergic drugs
  • Lifetime diagnosis of schizophrenia, schizoaffective disorder, substance-induced psychotic disorder, or bipolar I disorder
  • Suicide risk requiring inpatient admission as assessed by psychiatrist
  • Taking more than 4 psychotropic medications
  • Planned changes to psychotropic medication or psychotherapy during study
  • Substance abuse or dependence requiring treatment in the last 3 months
  • Pregnant, breastfeeding, or not using appropriate contraception if of child-bearing age

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 12 weeks

Participants receive either the active drug or placebo daily for 12 weeks as part of the trial treatment.

Weekly visits for up to 12 weeks

Trial Site Locations

Total: 1 location

1

Monash Alfred Psychiatry Research Centre

Melbourne, Victoria, Australia, 3004

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Research Team

J

Jayashri Kulkarni AM, MBBS,MPM,FRANZCP,PhD

A

Anthony deCastella, DipAppSci,BA,MA

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Effect of the Glutamate NMDA Receptor Antagonist Memantine as Adjunctive Treatment in Borderline Personality Disorder: An Exploratory, Randomised, Double-Blind, Placebo-Controlled Trial.

Jayashri Kulkarni, Natalie Thomas, Abdul-Rahman Hudaib...

https://pubmed.ncbi.nlm.nih.gov/29549516