Borderline Personality DisorderPhase 2NCT02097706
A Novel Drug for Borderline Personality Disorder
A Phase 2 study testing NMDA receptor antagonist (active drug) and Lactose packed capsule (inert/inactive arm) in people with Borderline Personality Disorder, run by The Alfred at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Borderline Personality Disorder
- What is being tested?
- NMDA receptor antagonist (active drug) and Lactose packed capsule (inert/inactive arm)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteAustralia
- Study dates
- Jan 2015to Dec 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants will be eligible to proceed in the study if they meet all of the following criteria (as determined in the screening session):
- Men and women aged between 18-65 years of age
- A current diagnosis of BPD, or a score ≥ 8 on Diagnostic Interview for Borderline patients, or a score ≥ 15 on Zanarini Rating Scale for Borderline Personality Disorder
- Proficient in reading and writing English
Who cannot join
- Potential participants who meet the criteria for any of the following will be excluded from participating in the study:
- Clinical evidence of acute delirium or severe head injury
- Epilepsy or other current seizure disorder, history of seizures or convulsions (not including febrile convulsions), or presence of predisposing factors for epilepsy.
- Clinically significant hepatic or renal impairment, haematological, or cardiovascular disease.
- Concomitant use of NMDA antagonists (amantadine, ketamine, dextromethorphan), L-dopa, dopamine agonists or anticholinergics.
- Lifetime diagnosis of schizophrenia, schizoaffective disorder, substance-induced psychotic disorder or bipolar I disorder (DSM-V).
Show all 11Show fewer
- Risk of suicide such that inpatient admission is required, as determined by PI (psychiatrist) on the basis of clinical assessment and baseline BPDSI-IV and/or ZAN-BPD suicide subscale scores.
- Taking more than 4 psychotropic medications.
- Planned changes to psychotropic medication or psychotherapy regime.
- Substance abuse or dependence requiring intervention or rehabilitation in last 3 months.
- Pregnant or breastfeeding; if of child-bearing age, not using appropriate contraceptive precaution.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
Monash Alfred Psychiatry Research Centre
Melbourne, Victoria, 3004
Jayashri Kulkarni AM, MBBS,MPM,FRANZCP,PhD, +61 3 9076 6924, j.kulkarni@alfred.org.au
Anthony deCastella, Dip App Sci, BA, MA, +61 3 9076 6554 ext. 66554, anthony.decastella@monash.edu
About this study
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
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.
Read more
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.
- Conditions
- Borderline Personality Disorder
- Being tested
- NMDA receptor antagonist (active drug), Lactose packed capsule (inert/inactive arm)
- Keywords
- Boderline Personality Disorder, Mental Illness, Cognition
- Medical subject headings
- Borderline Personality Disorder, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NMDA receptor antagonist (active drug)Drug
Lactose packed capsule (inert/inactive arm)Other
| Study group | Role | What they receive |
|---|---|---|
| NMDA receptor antagonist | Active comparator | 20mg/daily for 12 weeks (84 days) Receives: Drug: NMDA receptor antagonist (active drug) |
| Placebo tablet | Placebo comparator | 1 capsule/daily for 12 weeks (84 days) Receives: Other: Lactose packed capsule (inert/inactive arm) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Weeks 0, 2, 4, 6, 8, 10, 12
Secondary outcomes (3)
Borderline Evaluation of Severity over Time (BEST)
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.
Measured: Weeks 0,2,4,6,8,10,12
BPDSI
Borderline Personality Disorder Severity Index-IV (BPDSI-IV)
Measured: Baseline and Week 12
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.
Measured: Baseline and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2014 (estimated)
- Study startJan 2015
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Borderline Personality DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Alfred
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jayashri Kulkarni, Professor, The Alfred
- Investigators
- Jayashri Kulkarni AM, MBBS,MPM,FRANZCP,PhD, Principal investigator, Bayside Health, Alfred Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02097706
- Sponsor's protocol ID
- 204-14
- Status last verified
- Nov 2024
- First submitted
- 25 Mar 2014
- Last updated
- 15 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
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.
PubMed 36375174Kulkarni 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.
PubMed 29549516
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02097706
- Acronym / sponsor ID
- 204-14
- Conditions
- Borderline Personality Disorder
- Keywords
- Boderline Personality Disorder, Mental Illness, Cognition
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- The AlfredUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 27 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NMDA receptor antagonist | Active comparator | Drug: NMDA receptor antagonist (active drug)20mg/daily for 12 weeks (84 days) |
| Placebo tablet | Placebo comparator | Other: Lactose packed capsule (inert/inactive arm)1 capsule/daily for 12 weeks (84 days) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants will be eligible to proceed in the study if they meet all of the following criteria (as determined in the screening session):
- Men and women aged between 18-65 years of age
- A current diagnosis of BPD, or a score ≥ 8 on Diagnostic Interview for Borderline patients, or a score ≥ 15 on Zanarini Rating Scale for Borderline Personality Disorder
- Proficient in reading and writing English
Key exclusion criteria (11 listed)
- Potential participants who meet the criteria for any of the following will be excluded from participating in the study:
- Clinical evidence of acute delirium or severe head injury
- Epilepsy or other current seizure disorder, history of seizures or convulsions (not including febrile convulsions), or presence of predisposing factors for epilepsy.
- Clinically significant hepatic or renal impairment, haematological, or cardiovascular disease.
- Concomitant use of NMDA antagonists (amantadine, ketamine, dextromethorphan), L-dopa, dopamine agonists or anticholinergics.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NMDA receptor antagonist (active drug) | Drug | NMDA receptor antagonist |
| Lactose packed capsule (inert/inactive arm) | Other | Placebo tablet |
Primary outcome
The Zanarini Rating Scale for Borderline Personality Disorder
Time frame: Weeks 0, 2, 4, 6, 8, 10, 12
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.
3 secondary outcomes
Borderline Evaluation of Severity over Time (BEST)
Time frame: Weeks 0,2,4,6,8,10,12
BPDSI
Time frame: Baseline and Week 12
Cogstate (cognitive assessment)
Time frame: Baseline and Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2025.
- Derived from this study: PubMed 36375174Stoffers-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.
- Derived from this study: PubMed 29549516Kulkarni 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.
- Individual participant dataSharing planned: No
Related trials for Borderline Personality Disorder
Recruiting
Repetitive Transcranial Magnetic Stimulation Versus Theta Burst Stimulation on Impulsivity, Emotional Dysregulation, and Non-Suicidal Self-Injury in Borderline Personality Disorder Patients
Borderline Personality Disorder (BPD)
Not yet recruitingPhase 2
Ketamine Infusion for Symptomatic Improvement in Severe Borderline Personality Disorder
Infusion of Ketamine in Severe Borderline Personality Disorder, Borderline Personality Disorder (BPD)
Recruiting
Combining Transcranial Magnetic Stimulation With Emotion Regulation Skills Training in Borderline Personality Disorder
Borderline Personality Disorder (BPD)
RecruitingPhase 2
MDMA in Borderline Personality Disorder
Borderline Personality Disorder
Active, not recruitingPhase 2
Mindfulness-based Neurofeedback to Augment Psychotherapy for Adults With Borderline Personality Disorder
Borderline Personality Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jayashri Kulkarni AM, MBBS,MPM,FRANZCP,PhD principal investigator
Bayside Health, Alfred Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NMDA receptor antagonist (active drug) and Lactose packed capsule (inert/inactive arm) in people with Borderline Personality Disorder, run by The Alfred at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jayashri Kulkarni AM, MBBS,MPM,FRANZCP,PhD (+61 3 90766924 ext. 66924, j.kulkarni@alfred.org.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Zanarini Rating Scale for Borderline Personality Disorder (time frame: Weeks 0, 2, 4, 6, 8, 10, 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02097706, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2025.