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A Novel Drug for Borderline Personality Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02097706
Recruitment Status : Recruiting
First Posted : March 27, 2014
Last Update Posted : January 9, 2020
Information provided by (Responsible Party):
Jayashri Kulkarni, Professor, The Alfred

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 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.

Condition or disease Intervention/treatment Phase
Borderline Personality Disorder Drug: NMDA receptor antagonist (active drug) Other: Lactose packed capsule (inert/inactive arm) Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (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
Study Start Date : January 2015
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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)

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02097706

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Contact: Jayashri Kulkarni, MBBS,MPM,FRANZCP,PhD +61 3 90766924 ext 66924
Contact: Anthony deCastella, DipAppSci,BA,MA +61 3 90766564 ext 66564

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Australia, Victoria
Monash Alfred Psychiatry Research Centre Recruiting
Melbourne, Victoria, Australia, 3004
Contact: Jayashri Kulkarni, MBBS,MPM,FRANZCP,PhD    +61 3 9076 6924   
Contact: Anthony deCastella, Dip App Sci, BA, MA    +61 3 9076 6554 ext 66554   
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         
Sponsors and Collaborators
The Alfred
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Principal Investigator: Jayashri Kulkarni, MBBS,MPM,FRANZCP,PhD Bayside Health, Alfred Hospital
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Jayashri Kulkarni, Professor, Professor, The Alfred Identifier: NCT02097706    
Other Study ID Numbers: 204-14
First Posted: March 27, 2014    Key Record Dates
Last Update Posted: January 9, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Jayashri Kulkarni, Professor, The Alfred:
Boderline Personality Disorder
Mental Illness
Additional relevant MeSH terms:
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Personality Disorders
Borderline Personality Disorder
Pathologic Processes
Mental Disorders