A new medication for treating Borderline Personality Disorder

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

This study is testing a new medication to see if it can help people with Borderline Personality Disorder feel better and manage their emotions more effectively.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: The Alfred (other)
• Locations: 1 site (Melbourne, Victoria)
• Trial ID: NCT02097706 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the efficacy of an NMDA receptor antagonist in treating Borderline Personality Disorder (BPD), a condition characterized by emotional dysregulation and impulsive behaviors. Participants aged 18-65 with a confirmed diagnosis of BPD will be enrolled and randomly assigned to receive either the active drug or a placebo. The study aims to assess the drug's impact on symptoms and overall functioning in individuals suffering from this debilitating mental illness.

Who should consider this trial

Good fit: Ideal candidates for this study are men and women aged 18-65 who have been diagnosed with Borderline Personality Disorder.

Not a fit: Patients with concurrent severe mental health disorders or neurological conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for patients with Borderline Personality Disorder.

How similar studies have performed: While there have been various approaches to treating BPD, the use of NMDA receptor antagonists is relatively novel and has not been extensively tested in this context.

Eligibility criteria

Inclusion criteria

Participants will be eligible to proceed in the study if they meet all of the following criteria (as determined in the screening session):

1. Men and women aged between 18-65 years of age
2. A current diagnosis of BPD, or a score ≥ 8 on Diagnostic Interview for Borderline patients, or a score ≥ 15 on Zanarini Rating Scale for Borderline Personality Disorder
3. Proficient in reading and writing English

Exclusion criteria

Potential participants who meet the criteria for any of the following will be excluded from participating in the study:

1. Clinical evidence of acute delirium or severe head injury
2. Epilepsy or other current seizure disorder, history of seizures or convulsions (not including febrile convulsions), or presence of predisposing factors for epilepsy.
3. Clinically significant hepatic or renal impairment, haematological, or cardiovascular disease.
4. Concomitant use of NMDA antagonists (amantadine, ketamine, dextromethorphan), L-dopa, dopamine agonists or anticholinergics.
5. Lifetime diagnosis of schizophrenia, schizoaffective disorder, substance-induced psychotic disorder or bipolar I disorder (DSM-V).
6. Risk of suicide such that inpatient admission is required, as determined by PI (psychiatrist) on the basis of clinical assessment and baseline BPDSI-IV and/or ZAN-BPD suicide subscale scores.
7. Taking more than 4 psychotropic medications.
8. Planned changes to psychotropic medication or psychotherapy regime.
9. Substance abuse or dependence requiring intervention or rehabilitation in last 3 months.
10. Pregnant or breastfeeding; if of child-bearing age, not using appropriate contraceptive precaution.

Where this trial is running

Melbourne, Victoria

• Monash Alfred Psychiatry Research Centre — Melbourne, Victoria, Australia (RECRUITING)

Study contacts

• Principal investigator: Jayashri Kulkarni AM, MBBS,MPM,FRANZCP,PhD — Bayside Health, Alfred Hospital
• Study coordinator: Jayashri Kulkarni AM, MBBS,MPM,FRANZCP,PhD

Conditions: Borderline Personality Disorder, Boderline Personality Disorder, Mental Illness, Cognition