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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02097706




Registration number
NCT02097706
Ethics application status
Date submitted
25/03/2014
Date registered
27/03/2014
Date last updated
9/01/2020

Titles & IDs
Public title
A Novel Drug for Borderline Personality Disorder
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
Secondary ID [1] 0 0
204-14
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Borderline Personality Disorder 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Psychosis and personality disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - NMDA receptor antagonist (active drug)
Other interventions - Lactose packed capsule (inert/inactive arm)

Active Comparator: NMDA receptor antagonist - 20mg/daily for 8 weeks (56 days)

Placebo Comparator: Placebo tablet - 1 capsule/daily for 8 weeks (56 days)


Treatment: Drugs: NMDA receptor antagonist (active drug)


Other interventions: Lactose packed capsule (inert/inactive arm)


Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The Zanarini Rating Scale for Borderline Personality Disorder - 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.
Timepoint [1] 0 0
Weeks 0,2,4,8
Secondary outcome [1] 0 0
Cogstate (cognitive assessment) - 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.
Timepoint [1] 0 0
baseline and week 8
Secondary outcome [2] 0 0
Borderline Evaluation of Severity over Time - 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.
Timepoint [2] 0 0
Weeks 0,2,4,8

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

3. Proficient in reading and writing English
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Monash Alfred Psychiatry Research Centre - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
The Alfred
Address
Country

Ethics approval
Ethics application status

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 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.
Trial website
https://clinicaltrials.gov/show/NCT02097706
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jayashri Kulkarni, MBBS,MPM,FRANZCP,PhD
Address 0 0
Bayside Health, Alfred Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Jayashri Kulkarni, MBBS,MPM,FRANZCP,PhD
Address 0 0
Country 0 0
Phone 0 0
+61 3 90766924
Fax 0 0
Email 0 0
j.kulkarni@alfred.org.au
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02097706