Infusion of Ketamine in Severe Borderline Personality DisorderPhase 2BorderKETNCT07099534
Ketamine Infusion for Symptomatic Improvement in Severe Borderline Personality Disorder
A Phase 2 study testing IV Ketamine (0.5 mg/kg) Infusion - Two Doses Administered 24 Hours Apart for Severe Borderline Personality Disorder in people with Infusion of Ketamine in Severe Borderline Personality Disorder and Borderline Personality Disorder (BPD), run by University Hospital, Toulouse at 1 site in France.
Trial summary
The main objective of this pilot study is to evaluate at D9 the evolution of BPD symptoms' intensity(scale BSL-23) in severe BPD patients, after two Ketamine infusions (0.5mg/kg at H0 and H24). The intervention is combined with the first level standard of care : Good Psychiatric Management (GPM). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Infusion of Ketamine in Severe Borderline Personality Disorder, Borderline Personality Disorder (BPD)
- What is being tested?
- IV Ketamine (0.5 mg/kg) Infusion - Two Doses Administered 24 Hours Apart for Severe Borderline Personality Disorder
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2027to 30 Sep 2029
- 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
- Adult patient aged 18 to 65 years
- Fluent in French
- Person affiliated with or receiving social security benefits.
- Diagnosis of borderline personality disorder established according to the DSM-5 MINI criteria (5 out of 9 criteria)
- Severe borderline personality disorder
- Patient receiving stable pharmacological (antipsychotic, mood stabilizer, antidepressant) and/or non-pharmacological (schema therapy, DBT) treatment for four weeks
Who cannot join
- Personal history of an acute psychotic episode or chronic psychotic disorder
- Personal history of a manic or hypomanic episode
- Family history (first-degree relatives) of a psychotic disorder
- Current severe depressive episode
- Recreational ketamine use (multi-weekly ketamine use)
- New long-term treatment introduced within the previous four weeks (antidepressant, antipsychotic, mood stabilizer)
Show all 10Show fewer
- Prescription of an Monoamine oxidase inhibitors (increased risk of hypertension)
- Specific absolute contraindication to ketamine
- History of cirrhosis or major liver function test abnormalities
- Major ECG abnormality
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Toulouse Purpan University Hospital, Head of Psychiatry Clinic in the UF3 department
Toulouse, 31059
Gaël Galliot, +33 (0)5 34 55 76 51 ext. 33, galliot.g@chu-toulouse.fr
Gaël Galliot
About this study
Official title: Ketamine Infusion for Symptomatic Improvement in Severe Borderline Personality Disorder: A Pilot Study
The main objective of this pilot study is to evaluate at D9 the evolution of BPD symptoms' intensity(scale BSL-23) in severe BPD patients, after two Ketamine infusions (0.5mg/kg at H0 and H24). The intervention is combined with the first level standard of care : Good Psychiatric Management (GPM). Patients are followed up to 3 months by regular visits conducted by a psychiatrist. Secondary outcomes are monitored including BPD symptoms at different times, suicidal ideation, depressiv symptoms, healthcare use and adverse effects.
Read the detailed description
Borderline personality disorder is a burden for patient's life and remains undertreated, no medication has FDA or AMM approval for this indication. On a neurobiological level, BPD is thought to involve defects in the regulation of the glutamatergic pathway, as well as circuit anomalies in the emotional pathways (limbic hyperactivation and deficient activation of the prefrontal cortex), which have been associated with impulsivity and emotional hyper-reactivity. Ketamine, an NMDA antagonist, has a pharmacological profile of interest for TPB, thanks to its excitatory action on the CPF and its inhibitory effect on limbic hyperactivity. Preliminary clinical data suggest an effect on TPB symptomatology, more data is needed to conduct a large scale study.
This pilot study aim to test the effect of two infusions of ketamine (0,5 mg/kg) in adults with severe BPD. The protocol consists of two IV ketamine injections over 40 min at a dose of 0.5 mg/kg each, at H0 and H24.The associated treatment will be in line with first-level recommendations, i.e. GPM-type psychotherapy.
Infusions are delivered under medical monitoring at hospital and patients are followed up to 3 months by regular psychiatric consultations. Change in BPD symptoms'intensity is measured by the scale BSL-23 at different times (baseline, H48, J9, J28, M3) up to 3 months. Suicidal ideations, depressive symptoms, health care sue and adverse effects are also monitored.
- Conditions
- Infusion of Ketamine in Severe Borderline Personality Disorder, Borderline Personality Disorder (BPD)
- Being tested
- IV Ketamine (0.5 mg/kg) Infusion - Two Doses Administered 24 Hours Apart for Severe Borderline Personality Disorder
- Keywords
- Ketamine, borderline personality disorder, BDP
- Medical subject headings
- Borderline Personality Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV Ketamine (0.5 mg/kg) Infusion - Two Doses Administered 24 Hours Apart for Severe Borderline Personality DisorderDrug
Participants receive two intravenous (IV) infusions of ketamine at a dose of 0.5 mg/kg over 40 minutes. The first infusion is administered at Hour 0 (H0) and the second at Hour 24 (H24). Vital signs and potential adverse effects are closely monitored before, during, and after each infusion. This intervention aims to assess the short-term efficacy and safety of ketamine in reducing symptoms of severe borderline personality disorder.
| Study group | Role | What they receive |
|---|---|---|
| IV Ketamine Double Infusion (0.5 mg/kg) for Severe Borderline Personality Disorder | Experimental | Not described Receives: Drug: IV Ketamine (0.5 mg/kg) Infusion - Two Doses Administered 24 Hours Apart for Severe Borderline Personality Disorder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Borderline Personality Disorder Symptom Severity (BSL-23) from Baseline (H0) to Day 9 (J9)
The primary outcome measure is the change in symptom severity of Borderline Personality Disorder (BPD) as assessed by the Borderline Symptom List-23 (BSL-23) from Baseline to Day 9 post perfusion. The BSL-23 is a self-reported scale measuring BPD symptom intensity, with scores ranging from 0 (no symptoms) to 92 (most severe symptoms). A higher score indicates greater symptom severity. The difference in total BSL-23 scores between Baseline and Day 9 will be analyzed to evaluate the short-term impact of IV ketamine treatment on BPD symptoms.
Measured: Baseline and Day 9 post perfusion
Secondary outcomes (5)
Change in Borderline Personality Disorder Symptom Severity (BSL-23) from Baseline to H48, Month 1 (M1), and Month 3 (M3)
This secondary outcome measure evaluates changes in symptom severity of Borderline Personality Disorder (BPD) using the Borderline Symptom List-23 (BSL-23) at multiple time points: H48, Month 1 (M1), and Month 3 (M3), compared to Baseline. The BSL-23 is a self-reported scale assessing BPD symptoms, with total scores ranging from 0 (no symptoms) to 92 (most severe symptoms). Higher scores indicate greater symptom severity. The difference in scores across these time points will be analyzed to assess the medium- to long-term impact of IV ketamine treatment on BPD symptoms.
Measured: Baseline, 48 hours, 1 month, and 3 months after first ketamine infusion.
Change in Borderline Personality Disorder Symptom Severity Measured by Zanarini-BPD Scale from Baseline to H48, D9, M1, and M3
The Zanarini-BPD scale assesses the severity of borderline personality disorder symptoms based on nine DSM-IV criteria. Each criterion is rated on a Likert scale from 0 to 4, with higher scores indicating greater symptom severity. The total score ranges from 0 to 36. This outcome measures the change in symptom severity from baseline to H48, D9, M1, and M3.
Measured: Baseline, 48 hours, Day 9, 1 month, and 3 months after first ketamine infusion.
Change in Suicidal Ideation Severity Measured by C-SSRS from Baseline to H48, D9, M1, and M3
The Columbia-Suicide Severity Rating Scale (C-SSRS) assesses suicidal ideation severity based on structured interview questions. Scores range from 0 (no suicidal ideation) to 5 (active suicidal intent with a plan). This outcome measures changes in severity from baseline to H48, D9, M1, and M3.
Measured: Baseline, 48 hours, Day 9, 1 month, and 3 months after first ketamine infusion.
Change in Depressive Symptom Severity Measured by MADRS from Baseline to H48, D9, M1, and M3
The Montgomery-Åsberg Depression Rating Scale (MADRS) assesses the severity of depressive symptoms based on a structured clinical interview. The scale includes 10 items, each rated from 0 (no symptoms) to 6 (severe symptoms), with a total score ranging from 0 to 60. Higher scores indicate more severe depression. This outcome measures changes in depressive symptom severity from baseline to H48, D9, M1, and M3.
Measured: Baseline, 48 hours, Day 9, 1 month, and 3 months after first ketamine infusion.
Number of Psychiatric Emergency Room Visits (Self-Reported, Day 9 to Month 3)
This outcome measure tracks the number of psychiatric emergency room visits reported by participants between Day 9 (J9) and Month 3 (M3). Visits are self-reported during follow-up assessments and, when possible, cross-checked with medical records. A psychiatric emergency visit is defined as any unplanned presentation to an emergency department for acute psychiatric symptoms, crisis management, or safety concerns. The data will be analyzed to evaluate the impact of IV ketamine treatment on emergency psychiatric care utilization over time.
Measured: From Day 9 (J9) to Month 3 (M3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2025
- Study start1 Jan 2027 (estimated)
- Primary completion30 Sep 2029 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infusion of Ketamine in Severe Borderline Personality DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07099534
- Sponsor's protocol ID
- RC31/23/0619
- Other IDs
- 2024-514361-19-00
- Acronym
- BorderKET
- Status last verified
- Nov 2026
- First submitted
- 25 Jul 2025
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ketamine Infusion for Symptomatic Improvement in Severe Borderline Personality Disorder: A Pilot Study
- ClinicalTrials.gov ID
- NCT07099534
- Acronym / sponsor ID
- BorderKET / RC31/23/0619
- Conditions
- Infusion of Ketamine in Severe Borderline Personality Disorder, Borderline Personality Disorder (BPD)
- Keywords
- Ketamine, borderline personality disorder, BDP
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 30 Sep 2029 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 1 Aug 2025 (actual)
- 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.
The main objective of this pilot study is to evaluate at D9 the evolution of BPD symptoms' intensity(scale BSL-23) in severe BPD patients, after two Ketamine infusions (0.5mg/kg at H0 and H24). The intervention is combined with the first level standard of care : Good Psychiatric Management (GPM). Patients are followed up to 3 months by regular visits conducted by a psychiatrist. Secondary outcomes are monitored including BPD symptoms at different times, suicidal ideation, depressiv symptoms, healthcare use and adverse effects.
Detailed description
Borderline personality disorder is a burden for patient's life and remains undertreated, no medication has FDA or AMM approval for this indication. On a neurobiological level, BPD is thought to involve defects in the regulation of the glutamatergic pathway, as well as circuit anomalies in the emotional pathways (limbic hyperactivation and deficient activation of the prefrontal cortex), which have been associated with impulsivity and emotional hyper-reactivity. Ketamine, an NMDA antagonist, has a pharmacological profile of interest for TPB, thanks to its excitatory action on the CPF and its inhibitory effect on limbic hyperactivity. Preliminary clinical data suggest an effect on TPB symptomatology, more data is needed to conduct a large scale study.
This pilot study aim to test the effect of two infusions of ketamine (0,5 mg/kg) in adults with severe BPD. The protocol consists of two IV ketamine injections over 40 min at a dose of 0.5 mg/kg each, at H0 and H24.The associated treatment will be in line with first-level recommendations, i.e. GPM-type psychotherapy.
Infusions are delivered under medical monitoring at hospital and patients are followed up to 3 months by regular psychiatric consultations. Change in BPD symptoms'intensity is measured by the scale BSL-23 at different times (baseline, H48, J9, J28, M3) up to 3 months. Suicidal ideations, depressive symptoms, health care sue and adverse effects are also monitored.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IV Ketamine Double Infusion (0.5 mg/kg) for Severe Borderline Personality Disorder | Experimental | Drug: IV Ketamine (0.5 mg/kg) Infusion - Two Doses Administered 24 Hours Apart for Severe Borderline Personality Disorder |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult patient aged 18 to 65 years
- Fluent in French
- Person affiliated with or receiving social security benefits.
- Diagnosis of borderline personality disorder established according to the DSM-5 MINI criteria (5 out of 9 criteria)
- Severe borderline personality disorder
Key exclusion criteria (10 listed)
- Personal history of an acute psychotic episode or chronic psychotic disorder
- Personal history of a manic or hypomanic episode
- Family history (first-degree relatives) of a psychotic disorder
- Current severe depressive episode
- Recreational ketamine use (multi-weekly ketamine use)
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 |
|---|---|---|
| IV Ketamine (0.5 mg/kg) Infusion - Two Doses Administered 24 Hours Apart for Severe Borderline Personality DisorderParticipants receive two intravenous (IV) infusions of ketamine at a dose of 0.5 mg/kg over 40 minutes. The first infusion is administered at Hour 0 (H0) and the second at Hour 24 (H24). Vital signs and potential adverse effects are closely monitored before, during, and after each infusion. This intervention aims to assess the short-term efficacy and safety of ketamine in reducing symptoms of severe borderline personality disorder. | Drug | IV Ketamine Double Infusion (0.5 mg/kg) for Severe Borderline Personality Disorder |
Primary outcome
Change in Borderline Personality Disorder Symptom Severity (BSL-23) from Baseline (H0) to Day 9 (J9)
Time frame: Baseline and Day 9 post perfusion
The primary outcome measure is the change in symptom severity of Borderline Personality Disorder (BPD) as assessed by the Borderline Symptom List-23 (BSL-23) from Baseline to Day 9 post perfusion. The BSL-23 is a self-reported scale measuring BPD symptom intensity, with scores ranging from 0 (no symptoms) to 92 (most severe symptoms). A higher score indicates greater symptom severity. The difference in total BSL-23 scores between Baseline and Day 9 will be analyzed to evaluate the short-term impact of IV ketamine treatment on BPD symptoms.
5 secondary outcomes
Change in Borderline Personality Disorder Symptom Severity (BSL-23) from Baseline to H48, Month 1 (M1), and Month 3 (M3)
Time frame: Baseline, 48 hours, 1 month, and 3 months after first ketamine infusion.
Change in Borderline Personality Disorder Symptom Severity Measured by Zanarini-BPD Scale from Baseline to H48, D9, M1, and M3
Time frame: Baseline, 48 hours, Day 9, 1 month, and 3 months after first ketamine infusion.
Change in Suicidal Ideation Severity Measured by C-SSRS from Baseline to H48, D9, M1, and M3
Time frame: Baseline, 48 hours, Day 9, 1 month, and 3 months after first ketamine infusion.
Change in Depressive Symptom Severity Measured by MADRS from Baseline to H48, D9, M1, and M3
Time frame: Baseline, 48 hours, Day 9, 1 month, and 3 months after first ketamine infusion.
Number of Psychiatric Emergency Room Visits (Self-Reported, Day 9 to Month 3)
Time frame: From Day 9 (J9) to Month 3 (M3)
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 4 Nov 2026.
- Individual participant dataSharing planned: No
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.
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 IV Ketamine (0.5 mg/kg) Infusion - Two Doses Administered 24 Hours Apart for Severe Borderline Personality Disorder in people with Infusion of Ketamine in Severe Borderline Personality Disorder and Borderline Personality Disorder (BPD), run by University Hospital, Toulouse at 1 site in France.
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 6 inclusion and 10 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: opening soon, as of the sponsor's last update on 4 Nov 2026. 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 France. 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. 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 Gaël Galliot (+33 (0)5 34 55 76 51 ext. 33, galliot.g@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Borderline Personality Disorder Symptom Severity (BSL-23) from Baseline (H0) to Day 9 (J9) (time frame: Baseline and Day 9 post perfusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Nov 2026.