A Novel Cognitive Enhancing Drug for Borderline Personality Disorder

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2014 by The Alfred
Sponsor:
Information provided by (Responsible Party):
Jayashri Kulkarni, Professor, The Alfred
ClinicalTrials.gov Identifier:
NCT02097706
First received: March 25, 2014
Last updated: July 2, 2014
Last verified: July 2014
  Purpose

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 cognitive enhancing drug as an addition to ongoing therapy with atypical antipsychotics in patients with Borderline Personality Disorder. This study will recruit 30 BPD patients who are currently stable on Quetiapine (25-150mg) medication for three weeks. 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.


Condition Intervention Phase
Borderline Personality Disorder
Drug: NMDA receptor antagonist (active drug)
Other: Lactose packed capsule (inert/inactive arm)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomised Double-blind Placebo Controlled Investigation of the Efficacy of a Novel Cognitive Enhancing Drug as an Adjunct in Patients With Borderline Personality Disorder

Resource links provided by NLM:


Further study details as provided by The Alfred:

Primary Outcome Measures:
  • The Zanarini Rating Scale for Borderline Personality Disorder [ Time Frame: Weeks 0,2,4,8 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Cogstate (cognitive assessment) [ Time Frame: baseline and week 8 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 30
Study Start Date: September 2014
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 18-35 years of age
  2. A diagnosis of BPD according to the Diagnostic Interview for Borderline patients
  3. Proficient in reading and writing English
  4. Stabilized on quetiapine 25- 150mg for at least 3 weeks prior to study entry.

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 memantine 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02097706

Contacts
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

Locations
Australia, Victoria
Monash Alfred Psychiatry Research Centre Not yet recruiting
Melbourne, Victoria, Australia, 3004
Contact: Jayashri Kulkarni, MBBS,MPM,FRANZCP,PhD    +61 3 9076 6924    j.kulkarni@alfred.org.au   
Contact: Anthony deCastella, Dip App Sci, BA, MA    +61 3 9076 6554 ext 66554    anthony.decastella@monash.edu   
Principal Investigator: Jayashri Kulkarni, MBBS,MPM,FRANZCP,PhD         
Sub-Investigator: Anthony deCastella, Dip AppSci,BA,MA         
Sub-Investigator: Emorfia Gavrilidis, BAppSci         
Sub-Investigator: Nirmala Lazar, PhD         
Sub-Investigator: Roisin Worsley, MBBS, FRACP         
Sub-Investigator: Tamsyn E Van Rheenen, PhD         
Sponsors and Collaborators
The Alfred
Investigators
Principal Investigator: Jayashri Kulkarni, MBBS,MPM,FRANZCP,PhD Bayside Health, Alfred Hospital
  More Information

No publications provided

Responsible Party: Jayashri Kulkarni, Professor, Professor, The Alfred
ClinicalTrials.gov Identifier: NCT02097706     History of Changes
Other Study ID Numbers: MAPrc Project- TBA
Study First Received: March 25, 2014
Last Updated: July 2, 2014
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by The Alfred:
Boderline Personality Disorder
Mental Illness
Cognition

Additional relevant MeSH terms:
Personality Disorders
Borderline Personality Disorder
Mental Disorders

ClinicalTrials.gov processed this record on July 22, 2014