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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
Date last updated
24/10/2024

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
Active comparator: NMDA receptor antagonist - 20mg/daily for 12 weeks (84 days)

Placebo comparator: Placebo tablet - 1 capsule/daily for 12 weeks (84 days)
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The Zanarini Rating Scale for Borderline Personality Disorder
Timepoint [1] 0 0
Weeks 0, 2, 4, 6, 8, 10, 12
Secondary outcome [1] 0 0
Cogstate (cognitive assessment)
Timepoint [1] 0 0
Baseline and Week 12
Secondary outcome [2] 0 0
Borderline Evaluation of Severity over Time (BEST)
Timepoint [2] 0 0
Weeks 0,2,4,6,8,10,12
Secondary outcome [3] 0 0
BPDSI
Timepoint [3] 0 0
Baseline and Week 12

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
Minimum age
18 Years
Maximum age
65 Years
Sex
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
1/01/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2025
Actual
Sample size
Target
150
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 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.
Trial website
https://clinicaltrials.gov/study/NCT02097706
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.
Public notes

Contacts
Principal investigator
Name 0 0
Jayashri Kulkarni AM, 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 AM, MBBS,MPM,FRANZCP,PhD
Address 0 0
Country 0 0
Phone 0 0
+61 3 90766924
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

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