A Phase 2 interventional study of Ketamine Hydrochloride and Midazolam Hydrochloride in Borderline Personality Disorder (BPD), Treatment-Resistant Major Depressive Disorder and Treatment-resistant Bipolar Depression, sponsored by Joshua Rosenblat. Recruiting at 1 site in Canada. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-07-29.
Sponsored by Joshua Rosenblat · Phase 2, Interventional, and Treatment
Among 24 studies in Borderline Personality Disorder with a site in Canada — 7 open to participants now, 8 under way, none of them phase 3. Borderline Personality Disorder · Canada.
Among the 24 studies in Borderline Personality Disorder with a site in Canada, this one is the 5th largest by planned enrollment of the 23 interventional ones that give a count, is one of 5 that started in 2026, is one of 2 in phase 2, and was the 23rd registered.
278 studies on the registry are indexed under Borderline Personality Disorder; 70 are open to participants now.
This study's planned enrollment of 120 is above the median of 70 across 221 interventional studies indexed under Borderline Personality Disorder.
Browse Borderline Personality Disorder studies →7 of the 24 studies in Borderline Personality Disorder with a site in Canada are open now.
A study can be open while its sites in Canada have not opened yet or have stopped. Only those recruiting at a site in Canada →
Of the 49 Borderline Personality Disorder studies recruiting now, 18 (37%) set no upper age limit and 30 (61%) stop at 75 or younger; 8 take children under 18; 11 take healthy volunteers.
This study: 18 Years to 70 Years · all sexes · no healthy volunteers.
The full table on the hub →24 studies; the count open now beside each. This study's row is marked.
First in 2001; this study’s year is marked. 5 started in 2026.
Median enrollment 60 across the 23 interventional studies, 16 across the 1 observational. Of the 15 that completed or were terminated, 0 (0%) have results posted.
None of the 24 has an industry lead sponsor. The 10 most frequent:
Joshua Rosenblat is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
Joshua Rosenblat has 1 study filed under Borderline Personality Disorder — fewer than ten, so there is no comparison to draw.
2 of the studies in Borderline Personality Disorder with a site in Canada that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06972368Ciusss de L'Est de l'Île de MontréalHome-Based tDCS for Depression in BPD | 2027-01-01 |
| NCT06675461Centre for Addiction and Mental HealthBrief Psychological Intervention for Suicidal Patients With Borderline Personality Disorder in the Emergency Department | 2027-08 |
Among the 24 studies in Borderline Personality Disorder with a site in Canada, from their registry updates:
Nothing recorded among them since 2026-09-25.
The goal of this clinical trial is to learn if intravenous (IV) ketamine with Dialectical Behavioural Therapy (DBT) reduces suicidal ideation in individuals with suicidality who have been diagnosed with Borderline Personality Disorder and either Major Depressive Disorder or Bipolar Disorder. The main question it aims to answer is:
Does IV ketamine and DBT produce more rapid and robust improvements in suicidal ideation (SI) severity between baseline and Day 35 compared to IV midazolam and DBT, as measured by changes in the Modified Scale for Suicidal Ideation (MSSI) scores ?
Researchers will compare six IV ketamine infusions and DBT to an active placebo (a look-alike substance that mimics some of ketamine's effects and not others) and DBT to see if IV ketamine with DBT is more effective at reducing SI severity.
Participants will:
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All participants in the trial will receive DBT. DBT will begin prior to ketamine infusions and will continue for 6 months of the trial. There will be individual DBT and also group DBT that will begin in Week 5 of the trial. Participants in this arm will receive six infusions of ketamine over a month. The first two infusions will be dosed at 0.5mg/kg over a period of 40 minutes. For infusions 3 and 4, patients will be flexibly dosed between 0.5 mg/kg to 0.75 mg/kg, depending on clinical response to first two infusions. For infusions 5 and 6, participants will be flexibly dosed between 0.5 mg/kg to 0.85 mg/kg.
Drug: Ketamine Hydrochloride · Behavioral: Dialectical Behavioral Therapy (DBT)
All participants in the trial will receive DBT. DBT will begin prior to midazolam infusions and will continue for 6 months of the trial. There will be individual DBT and also group DBT that will begin in Week 5 of the trial. Participants in this arm will receive six infusions of midazolam over a month. The first two infusions will be dosed at 0.02 mg/kg over a period of 40 minutes. For infusions 3 and 4, patients will be flexibly dosed between 0.02 mg/kg to 0.03 mg/kg, depending on clinical response to first two infusions. For infusions 5 and 6, participants will be flexibly dosed between 0.2 mg/kg to 0.035 mg/kg.
Drug: Midazolam Hydrochloride · Behavioral: Dialectical Behavioral Therapy (DBT)
Participants in this arm will receive six ketamine hydrochloride infusions over a month, with doses ranging between 0.5 mg/kg to 0.85 mg/kg
Participants in this arm will receive six midazolam hydrochloride infusions over a month, with doses ranging between 0.02 mg/kg to 0.035 mg/kg
All participants in this trial will receive DBT over six months. Eligible participants will begin with weekly individual sessions, followed by the addition of weekly group sessions beginning in week 5 of the trial.
Change in suicidal ideation severity using the Modified Scale for Suicidal Ideation (MSSI)
The MSSI is a clinician administered scale used to assess presence or absence of suicidal ideation as well as intensity of suicidal ideation in the previous 48 hours. It consists of 18 items, with each item scored from 0 to 3. Total scores are summed and severity can be categorized as low (0-3), mild (9-20), or severe (\>21).
Time frame: From Baseline to Day 35 (Primary Endpoint)
Changes in suicidal ideation severity over a longer period of time using the Modified Scale for Suicidal Ideation (MSSI)
Evaluating changes in MSSI scores between baseline and Month 6 and between baseline and Month 9. The MSSI is a clinician administered scale used to assess presence or absence of suicidal ideation as well as intensity of suicidal ideation in the previous 48 hours. It consists of 18 items, with each item scored from 0 to 3. Total scores are summed and severity can be categorized as low (0-3), mild (9-20), or severe (\>21).
Time frame: From Baseline to Month 6 and Month 9
Changes in suicidal behavior (SB) and self-harm (SH) using the Suicide Attempt Self-Injury Interview (SASII)
The SASII is a semi-structured interview that will measure suicidal behavior and self-harm. The SASII is used to collect details of the topography, intent, medical severity, social context, precipitating and concurrent events, and outcomes of non-suicidal self-injury and suicidal behavior during a target time period (in this trial, the target time period will be 'past 3 months').
Time frame: From Baseline to Months 3, 6, and 9
Changes in suicidal behavior (SB) and self-harm (SH) using the Lifetime Suicide Attempt Self-Injury Interview (L-SASII)
The L-SASII will be administered at baseline to obtain a count of lifetime history of suicide attempts and non-suicidal self-injury.
Time frame: From Baseline to Months 3, 6, and 9
Changes in depression severity using the Montgomery Asberg Depression Rating Scale (MADRS)
The MADRS is a clinician-rated scale measuring depression severity. It consists of 10 items, each scored from 0 (normal) to 6 (severe), for a total possible score of 60. A higher score is indicative of greater depressive severity.
Time frame: From Baseline to Day 35 (Primary Endpoint), Month 6 and Month 9
Changes in personality psychopathology evaluated using the Borderline Symptom List-23 (BSL-23)
Changes in borderline personality disorder symptom severity and general personality psychopathology will be evaluated using the BSL-23, self-report assessment. This scale assesses a list of 23 problems on a scale of 0-4.
Time frame: From Baseline to Day 35 (Primary Endpoint), Month 6 and Month 9
Changes in personality psychopathology using Level of Personality Functioning Scale (LPFS)
Changes in borderline personality disorder symptom severity and general personality psychopathology will be assessed using the LPFS, an 80-item self-report assessment. Items are rated on a scale from 1 to 4, with 1 indicating "totally false, not true at all" and 4 indicating "very true".
Time frame: From Baseline to Day 35 (Primary Endpoint), Month 6 and Month 9
Changes in personality psychopathology using the Symptom-Checklist-90-Revised (SCL-90-R)
Changes in borderline personality disorder symptom severity and general personality psychopathology will be assessed using the SCL-90-R, a 90-item self-report assessment.
Time frame: From Baseline to Day 35 (Primary Endpoint), Month 6 and Month 9
Changes in anxiety as measured by the Generalized Anxiety Disorder-7 (GAD-7)
The GAD-7 is a brief self-report measure of generalized anxiety. It consists of 7 items rated from 0 ('not at all sure') to 3 ('nearly every day').
Time frame: From Baseline to Day 35 (Primary Endpoint), Month 6 and Month 9
Safety and tolerability evaluated by Adverse Events
Safety and tolerability will be evaluated by acute and sub-acute treatment-emergent adverse events using standardized adverse effects monitoring.
Time frame: Across 9 Months
Safety and tolerability measured by using the Clinician Administered Dissociative Symptom Scale (CADSS)
Safety and tolerability will be evaluated using CADSS. It is a clinician administered instrument for the measurement of present-state dissociative symptoms. It is a 27-item scale with 19 subject-rated items and 8-items scored by an observer.
Time frame: Across 9 months
Safety and tolerability evaluated by the Brief Psychiatric Rating Scale - Positive Symptom Subscale (BPRS-PS)
The BPRS is a clinician-administered scale that measures positive symptoms, general psychopathology, and affective symptoms to measure psychopathology severity. The positive symptoms subscale will be administered, which measures symptoms commonly seen in psychosis, including unusual thought content, conceptual disorganization, hallucinatory behaviour, and grandiosity.
Time frame: Across 9 months
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jul 2026; primary completion for Jan 2029, 30 months later.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Ketamine
Borderline Personality Disorder →
Joshua Rosenblat