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A Novel Drug for Borderline Personality Disorder

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ClinicalTrials.gov Identifier: NCT02097706
Recruitment Status : Recruiting
First Posted : March 27, 2014
Last Update Posted : January 11, 2018
Sponsor:
Information provided by (Responsible Party):
Jayashri Kulkarni, Professor, The Alfred

March 25, 2014
March 27, 2014
January 11, 2018
January 2015
December 2018   (Final data collection date for primary outcome measure)
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.
The Zanarini Rating Scale for Borderline Personality Disorder [ Time Frame: Weeks 0,1,2,4,8 ]
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.
Complete list of historical versions of study NCT02097706 on ClinicalTrials.gov Archive Site
  • 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.
  • 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.
Not Provided
Not Provided
 
A Novel Drug for 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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Borderline Personality Disorder
  • Drug: NMDA receptor antagonist (active drug)
  • Other: Lactose packed capsule (inert/inactive arm)
  • Active Comparator: NMDA receptor antagonist
    20mg/daily for 8 weeks (56 days)
    Intervention: Drug: NMDA receptor antagonist (active drug)
  • Placebo Comparator: Placebo tablet
    1 capsule/daily for 8 weeks (56 days)
    Intervention: Other: Lactose packed capsule (inert/inactive arm)
Kulkarni J, Thomas N, Hudaib AR, Gavrilidis E, Grigg J, Tan R, Cheng J, Arnold A, Gurvich C. Effect of the Glutamate NMDA Receptor Antagonist Memantine as Adjunctive Treatment in Borderline Personality Disorder: An Exploratory, Randomised, Double-Blind, Placebo-Controlled Trial. CNS Drugs. 2018 Feb;32(2):179-187. doi: 10.1007/s40263-018-0506-8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
Same as current
December 2018
December 2018   (Final data collection date for primary outcome measure)

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 diagnosis of BPD according to the Diagnostic Interview for Borderline patients
  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 CNS pathology, neurological disorder, head injury, epileptic seizures or convulsions.
  2. Currently pregnant or breastfeeding
  3. A current DSM-IV-TR diagnosis of substance abuse or dependence disorder, or another Axis I disorder including a past or current diagnosis of schizophrenia, delusional (paranoid) disorder, schizoaffective disorder, bipolar I (mixed, manic, depressed or euthymic) or psychotic depression. Individuals with bipolar II will be included
  4. Clinically significant and active evidence of liver or kidney disease, hematological, respiratory, endocrine or cardiovascular disease.
  5. Use of prescription drugs that may cause relevant drug interactions with the study drug according to the summary of product characteristics: NMDAR antagonists (amantadine, ketamine, dextromethorphan), L-Dopa, dopamine agonists and cholinergic agonists.
  6. Commencing new psychotherapy/ new medication during the trial period.
  7. History of mental retardation or documented IQ below 75
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact: Jayashri Kulkarni, MBBS,MPM,FRANZCP,PhD +61 3 90766924 ext 66924 j.kulkarni@alfred.org.au
Contact: Anthony deCastella, DipAppSci,BA,MA +61 3 90766564 ext 66564 a.decastella@alfred.org.au
Australia
 
 
NCT02097706
204-14
Yes
Not Provided
Plan to Share IPD: No
Jayashri Kulkarni, Professor, The Alfred
The Alfred
Not Provided
Principal Investigator: Jayashri Kulkarni, MBBS,MPM,FRANZCP,PhD Bayside Health, Alfred Hospital
The Alfred
January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP