A Novel Drug for Borderline Personality Disorder
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- injurious behaviour.
However, there are no pharmacologic interventions that are known to be specifically effective to treat BPD. Therapeutic options for this devastating disorder is still far from adequate for treating acute illness episodes, relapses, and recurrences and in restoring premorbid functioning. In addition, some patients are unable to tolerate existing therapies for BPD, which leads to either frequent changes in medications or to non-adherence. Therefore there is an urgent need for the development of more rapidly effective treatments for BPD.
A growing body of evidence suggests that glutamatergic neurotransmission, in particular N-methyl-D-aspartate (NMDA) subtype may play a role in the pathophysiology of multiple psychiatric disorders. This has led to various clinical trials with glutamate modulating drugs. The trial drug is an uncompetitive NMDA receptor antagonist approved for Alzheimer's disease is increasingly being studied in a variety of non-dementia psychiatric disorders. Results from these studies have proved that the trial drug was safe and well tolerated and has the potential for use in the treatment of psychiatric disorders.
To date, there are no published data on the use of trial drug in the treatment for BPD. Therefore, the investigators intend to study the efficacy of this novel drug as an addition to ongoing therapy with atypical antipsychotics in patients with Borderline Personality Disorder. This study will recruit 30 BPD patients. The patients will be randomly allocated to receive either the study medication (20mg/ day) or placebo via oral administration for eight weeks. To observe the efficacy of the trial treatment, all participants will be assessed at various time intervals for different borderline and cognitive symptoms.
|Borderline Personality Disorder||Drug: NMDA receptor antagonist (active drug) Other: Lactose packed capsule (inert/inactive arm)||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
|Official Title:||A Randomised Double-blind Placebo Controlled Investigation of the Efficacy of a Novel Drug as an Adjunct in Patients With Borderline Personality Disorder|
- The Zanarini Rating Scale for Borderline Personality Disorder [ Time Frame: Weeks 0,2,4,8 ]The Zanarini Rating Scale is a nine-item, validated, clinician-based diagnostic interview. It assesses the severity of DSM-IV-based Borderline personality disorder symptoms. This scale also measures meaningful changes in symptoms over time.
- Cogstate (cognitive assessment) [ Time Frame: baseline and week 8 ]Cogstate tests have been designed, developed and validated to both identify and measure cognitive impairment, and to track or monitor cognitive change. The tasks use novel visual and verbal stimuli to ensure assessment is culture-neutral and not limited by a participant's level of education.
- Borderline Evaluation of Severity over Time [ Time Frame: Weeks 0,2,4,8 ]The Borderline Evaluation of Severity over Time is a 15-item self-report measure used to assess the severity of and change in borderline symptoms over the course of treatment.
|Study Start Date:||January 2015|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
Active Comparator: NMDA receptor antagonist
20mg/daily for 8 weeks (56 days)
|Drug: NMDA receptor antagonist (active drug)|
Placebo Comparator: Placebo tablet
1 capsule/daily for 8 weeks (56 days)
|Other: Lactose packed capsule (inert/inactive arm)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT02097706
|Contact: Jayashri Kulkarni, MBBS,MPM,FRANZCP,PhD||+61 3 90766924 ext firstname.lastname@example.org|
|Contact: Anthony deCastella, DipAppSci,BA,MA||+61 3 90766564 ext email@example.com|
|Monash Alfred Psychiatry Research Centre||Recruiting|
|Melbourne, Victoria, Australia, 3004|
|Contact: Jayashri Kulkarni, MBBS,MPM,FRANZCP,PhD +61 3 9076 6924 firstname.lastname@example.org|
|Contact: Anthony deCastella, Dip App Sci, BA, MA +61 3 9076 6554 ext 66554 email@example.com|
|Principal Investigator: Jayashri Kulkarni, MBBS,MPM,FRANZCP,PhD|
|Sub-Investigator: Anthony deCastella, Dip AppSci,BA,MA|
|Sub-Investigator: Emorfia Gavrilidis, BAppSci|
|Sub-Investigator: Roisin Worsley, MBBS, FRACP|
|Sub-Investigator: Jasmin Grigg, PhD|
|Principal Investigator:||Jayashri Kulkarni, MBBS,MPM,FRANZCP,PhD||Bayside Health, Alfred Hospital|