Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02097706
Registration number
NCT02097706
Ethics application status
Date submitted
25/03/2014
Date registered
27/03/2014
Titles & IDs
Public title
A Novel Drug for Borderline Personality Disorder
Query!
Scientific title
A Randomised Double-blind Placebo Controlled Investigation of the Efficacy of a Novel Drug as an Adjunct in Patients With Borderline Personality Disorder
Query!
Secondary ID [1]
0
0
204-14
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Borderline Personality Disorder
0
0
Query!
Condition category
Condition code
Mental Health
0
0
0
0
Query!
Psychosis and personality disorders
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Active comparator: NMDA receptor antagonist - 20mg/daily for 12 weeks (84 days)
Placebo comparator: Placebo tablet - 1 capsule/daily for 12 weeks (84 days)
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
The Zanarini Rating Scale for Borderline Personality Disorder
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Weeks 0, 2, 4, 6, 8, 10, 12
Query!
Primary outcome [2]
0
0
Borderline Evaluation of Severity over Time (BEST)
Query!
Assessment method [2]
0
0
The Borderline Evaluation of Severity over Time (BEST) is a 15-item self-report measure that allows patients with borderline personality disorder (BPD) to rate the degree of impairment or interference from each of the nine BPD criteria over the past two weeks. Each time is rated on a 5-point scale, and scores can range from 12 to 72. Subscales include negative thoughts and feelings, positive behaviours and negative behaviours. The BEST is used to assess the severity of and change in borderline symptoms over the course of treatment.
Query!
Timepoint [2]
0
0
Weeks 0,2,4,6,8,10,12
Query!
Secondary outcome [1]
0
0
Cogstate (cognitive assessment)
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Baseline and Week 12
Query!
Secondary outcome [2]
0
0
BPDSI
Query!
Assessment method [2]
0
0
Borderline Personality Disorder Severity Index-IV (BPDSI-IV)
Query!
Timepoint [2]
0
0
Baseline and Week 12
Query!
Eligibility
Key inclusion 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 18-65 years of age
2. A diagnosis of BPD according to the Diagnostic Interview for Borderline patients or the Zanarini Rating Scale for Borderline Personality Disorder
3. Proficient in reading and writing English
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
65
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/01/2015
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
1/12/2025
Query!
Actual
Query!
Sample size
Target
150
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
VIC
Query!
Recruitment hospital [1]
0
0
Monash Alfred Psychiatry Research Centre - Melbourne
Query!
Recruitment postcode(s) [1]
0
0
3004 - Melbourne
Query!
Funding & Sponsors
Primary sponsor type
Other
Query!
Name
The Alfred
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
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 150 BPD patients. The patients will be randomly allocated to receive either the study medication (20mg/ day) or placebo via oral administration for twelve weeks. To observe the efficacy of the trial treatment, all participants will be assessed at various time intervals for different borderline and cognitive symptoms.
Query!
Trial website
https://clinicaltrials.gov/study/NCT02097706
Query!
Trial related presentations / publications
Stoffers-Winterling JM, Storebo OJ, Pereira Ribeiro J, Kongerslev MT, Vollm BA, Mattivi JT, Faltinsen E, Todorovac A, Jorgensen MS, Callesen HE, Sales CP, Schaug JP, Simonsen E, Lieb K. Pharmacological interventions for people with borderline personality disorder. Cochrane Database Syst Rev. 2022 Nov 14;11(11):CD012956. doi: 10.1002/14651858.CD012956.pub2. 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.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Jayashri Kulkarni AM, MBBS,MPM,FRANZCP,PhD
Query!
Address
0
0
Bayside Health, Alfred Hospital
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Jayashri Kulkarni AM, MBBS,MPM,FRANZCP,PhD
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
+61 3 90766924
Query!
Fax
0
0
Query!
Email
0
0
[email protected]
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
Query!
No/undecided IPD sharing reason/comment
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT02097706