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A Novel Drug for Borderline Personality Disorder

RecruitingPhase 2Ages 18 Years - 65 YearsAllThe Alfred
NCT02097706 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Borderline Personality Disorder (BPD) is one of the most prevalent psychiatric disorders with high morbidity and mortality. It affects the lives of millions worldwide and is often highly incapacitating, leading to significant psychosocial dysfunction. Moreover, nearly all patients have experienced suicidal ideation and about 10% actually commit suicide, a rate almost 50 times higher than in the general population. Mostly young women are at greater risk for the disorder and are three times more likely to be diagnosed with BPD than men. BPD aetiology is complex and could be explained by both biological and environmental factors. Among the environmental factors, sexual or physical abuse, parental divorce, loss or illnesses are identified as the most common ones. These factors can induce dysfunctional behaviours, which might cause emotional dysregulation, high impulsivity and frequent self-

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📋 Eligibility rules (as published)
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.
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What it tests

  • NMDA receptor antagonist (active drug)
  • Lactose packed capsule (inert/inactive arm)
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Where

1 site
Monash Alfred Psychiatry Research Centre
Melbourne, Australia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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