Clinical Trial: A Novel Drug for Borderline Personality Disorder
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
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
Brief Summary:
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 fo
Detailed Summary:
Sponsor: The Alfred
Current Primary Outcome: The Zanarini Rating Scale for Borderline Personality Disorder [ Time Frame: Weeks 0,2,4,8 ]
Original Primary Outcome: The Zanarini Rating Scale for Borderline Personality Disorder [ Time Frame: Weeks 0,1,2,4,8 ]
Current Secondary Outcome:
- 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.
Original Secondary Outcome:
- The Montgomery-Asberg Depression Scale (MADRS) [ Time Frame: Weeks 0,1,2,4,8. ]The Montgomery-Asberg Depression Scale (MADRS) is a 10 item semi-structured clinician-rated interview of depression where each item is rated on a 7 point scale ranging from 0 to 6. The MADRS will be used to monitor the participant's experience of depressive symptoms and severity across the trial.
- 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.
Information By: The Alfred
Dates:
Date Received: March 25, 2014
Date Started: January 2015
Date Completion: December 2016
Last Updated: March 1, 2016
Last Verified: March 2016
