Borderline Personality Disorder (BPD)Phase 2KET-DBTNCT07569198
Ketamine With Dialectical Behavioural Therapy (DBT) for Suicidality in Individuals With Treatment-Resistant Depression and Borderline Personality Disorder (KET-DBT)
A Phase 2 study testing Ketamine Hydrochloride, Midazolam Hydrochloride and Dialectical Behavioral Therapy (DBT) in people with Borderline Personality Disorder (BPD) and Treatment-Resistant Major Depressive Disorder, run by Joshua Rosenblat at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Borderline Personality Disorder (BPD), Treatment-Resistant Major Depressive Disorder, Treatment-resistant Bipolar Depression
- What is being tested?
- Ketamine Hydrochloride, Midazolam Hydrochloride and Dialectical Behavioral Therapy (DBT)
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- 16 Jul 2026to Aug 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults between the age of 18 to 70, inclusive;
- Meets criteria for BPD, as determined by clinical assessment by a psychiatrist or psychologist and confirmed by the International Personality Disorder Examination (IPDE);
- Meets DSM-5 criteria for MDD or BD (I or II), currently experiencing a MDE without psychotic features, as diagnosed by a study psychiatrist or psychologist. Diagnosis will be confirmed using the Mini- International Neuropsychiatric Interview (MINI);
- Current MDE must be moderate to severe, as determined by the MADRS score >20 with an inadequate response to two or more guideline-concordant treatment trials as defined by the Antidepressant Treatment History Form-Short Form (ATHF- SF);
- No changes in pharmacotherapy for MDD/BD in the last month or changes in psychotherapy in the past month;
- Baseline SI as shown by two consecutive MSSI scores > 10 two weeks apart.
Who cannot join
- Past or current history of a psychotic disorder as determined by clinical assessment and MINI;
- Current or recent (within the past 3 months) manic or hypomanic episode as determined by clinical assessment via YMRS (score > 12) and the MINI;
- Meeting criteria for Moderate to Severe Alcohol or substance use disorders currently or within the past 3 months;
- Lifetime history of ketamine use disorder or illicit ketamine use.
- Acute suicide risk requiring involuntary inpatient treatment under the Mental Health Act (MHA).
- Presence of a relative or absolute contraindication to ketamine or midazolam, including a drug allergy, lifetime history of stroke, uncontrolled hypertension (Systolic BP > 160 or Diastolic BP > 100), low or labile blood pressure (Systolic BP < 100 or Diastolic BP < 60), recent (within the past 6 months) myocardial infarction, severe coronary artery disease (ascertained through participant's medical history), or moderate to severe renal (GFR scores ≤ 44) or hepatic impairment (A Child-Pugh score of ≥ 7);
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- Currently pregnant or breastfeeding or planning on getting pregnant within the first two months of the trial or planning on getting someone else pregnant within the first two months of trial. Participants who are sexually active must agree to use a highly effective contraceptive method (please see exhaustive list in Section 3.6.1);
- Current use of prohibited concomitant medications, including other forms of ketamine or esketamine, high dose daily benzodiazepines (greater than 4 mg lorazepam equivalent daily) or monoamine oxidase inhibitors;
- Currently engaged (or completed within the past year) in DBT treatment. NOTE: Individuals who have received only DBT skills training in the past year will be considered eligible to participate;
- Those engaged in other forms of psychotherapy must be willing to discontinue for the duration of the 6-month DBT intervention (standard for DBT). There should be no changes in psychotherapy 30 days prior to baseline (i.e., Screening Visit 2).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Deep Grewal contact
Canada1 site, 1 recruiting
- Recruiting
Toronto Western Hospital
Toronto, Ontario, M5T 2S8
Diana Orsini, 416-603-5106 ext. 4221, ket.dbt@uhn.ca
Deep Grewal, actu@uhn.ca
About this study
Official title: Combining Ketamine With Dialectical Behavioural Therapy (DBT) for Suicidality in Individuals With Treatment-Resistant Depression and Borderline Personality Disorder: A Phase II Randomized, Midazolam-Controlled Clinical Trial (KET-DBT)
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 ?
Read more
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:
- Complete six infusions of either IV ketamine or IV midazolam
- Take part in 6 months of DBT (includes both weekly one-on-one sessions, and group sessions, starting week 5 of the trial)
- Visit the hospital for scheduled in-person visits
- Join a call or videocall for scheduled remote visits
- Complete a variety of different mood, cognitive and behavioral assessments
- Conditions
- Borderline Personality Disorder (BPD), Treatment-Resistant Major Depressive Disorder, Treatment-resistant Bipolar Depression, Major Depressive Disorder (MDD), Bipolar Disorder (BD), Bipolar Disorder I or II
- Being tested
- Ketamine Hydrochloride, Midazolam Hydrochloride, Dialectical Behavioral Therapy (DBT)
- Keywords
- Dialectical Behavioural Therapy (DBT), ketamine, Borderline Personality Disorder, Treatment-Resistant Depression, Bipolar Disorder (BD), Major Depressive Disorder (MDD), Suicidality
- Medical subject headings
- Borderline Personality Disorder, Depressive Disorder, Major, Bipolar Disorder, Suicidal Ideation, Depressive Disorder, Treatment-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketamine HydrochlorideDrug
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
Midazolam HydrochlorideDrug
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
Dialectical Behavioral Therapy (DBT)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Ketamine and Dialectical Behavioural Therapy | Experimental | 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. Receives: Drug: Ketamine Hydrochloride; Behavioral: Dialectical Behavioral Therapy (DBT) |
| Midazolam and Dialectical Behavioural Therapy | Placebo comparator | 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. Receives: Drug: Midazolam Hydrochloride; Behavioral: Dialectical Behavioral Therapy (DBT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From Baseline to Day 35 (Primary Endpoint)
Secondary outcomes (11)
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).
Measured: 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').
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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".
Measured: 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.
Measured: 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').
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Across 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start16 Jul 2026 (estimated)
- Primary completionJan 2029 (estimated)
- Study completionAug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Borderline Personality Disorder (BPD)Studies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Joshua Rosenblat
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Joshua Rosenblat, University Health Network, Toronto
- Investigators
- Joshua D. Rosenblat, MD, MSc, Principal investigator, Toronto Western Hospital, Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07569198
- Sponsor's protocol ID
- 25-5431
- Acronym
- KET-DBT
- Status last verified
- Jul 2026
- First submitted
- 13 Apr 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combining Ketamine With Dialectical Behavioural Therapy (DBT) for Suicidality in Individuals With Treatment-Resistant Depression and Borderline Personality Disorder: A Phase II Randomized, Midazolam-Controlled Clinical Trial (KET-DBT)
- ClinicalTrials.gov ID
- NCT07569198
- Acronym / sponsor ID
- KET-DBT / 25-5431
- Conditions
- Borderline Personality Disorder (BPD), Treatment-Resistant Major Depressive Disorder, Treatment-resistant Bipolar Depression, Major Depressive Disorder (MDD), Bipolar Disorder (BD), Bipolar Disorder I or II
- Keywords
- Dialectical Behavioural Therapy (DBT), ketamine, Borderline Personality Disorder, Treatment-Resistant Depression, Bipolar Disorder (BD), Major Depressive Disorder (MDD), Suicidality
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Joshua RosenblatUniversity, hospital or other
- Study start
- 16 Jul 2026 (estimated)
- Primary completion
- Jan 2029 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 6 May 2026 (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 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:
- Complete six infusions of either IV ketamine or IV midazolam
- Take part in 6 months of DBT (includes both weekly one-on-one sessions, and group sessions, starting week 5 of the trial)
- Visit the hospital for scheduled in-person visits
- Join a call or videocall for scheduled remote visits
- Complete a variety of different mood, cognitive and behavioral assessments
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketamine and Dialectical Behavioural Therapy | Experimental | Drug: Ketamine Hydrochloride, Behavioral: Dialectical Behavioral Therapy (DBT)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. |
| Midazolam and Dialectical Behavioural Therapy | Placebo comparator | Drug: Midazolam 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults between the age of 18 to 70, inclusive;
- Meets criteria for BPD, as determined by clinical assessment by a psychiatrist or psychologist and confirmed by the International Personality Disorder Examination (IPDE);
- Meets DSM-5 criteria for MDD or BD (I or II), currently experiencing a MDE without psychotic features, as diagnosed by a study psychiatrist or psychologist. Diagnosis will be confirmed using the Mini- International Neuropsychiatric Interview (MINI);
- Current MDE must be moderate to severe, as determined by the MADRS score >20 with an inadequate response to two or more guideline-concordant treatment trials as defined by the Antidepressant Treatment History Form-Short Form (ATHF- SF);
- No changes in pharmacotherapy for MDD/BD in the last month or changes in psychotherapy in the past month;
Key exclusion criteria (10 listed)
- Past or current history of a psychotic disorder as determined by clinical assessment and MINI;
- Current or recent (within the past 3 months) manic or hypomanic episode as determined by clinical assessment via YMRS (score > 12) and the MINI;
- Meeting criteria for Moderate to Severe Alcohol or substance use disorders currently or within the past 3 months;
- Lifetime history of ketamine use disorder or illicit ketamine use.
- Acute suicide risk requiring involuntary inpatient treatment under the Mental Health Act (MHA).
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 |
|---|---|---|
| Ketamine HydrochlorideParticipants 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 | Drug | Ketamine and Dialectical Behavioural Therapy |
| Midazolam HydrochlorideParticipants 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 | Drug | Midazolam and Dialectical Behavioural Therapy |
| Dialectical Behavioral Therapy (DBT)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. | Behavioural | Ketamine and Dialectical Behavioural Therapy, Midazolam and Dialectical Behavioural Therapy |
Primary outcome
Change in suicidal ideation severity using the Modified Scale for Suicidal Ideation (MSSI)
Time frame: From Baseline to Day 35 (Primary Endpoint)
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).
11 secondary outcomes
Changes in suicidal ideation severity over a longer period of time using the Modified Scale for Suicidal Ideation (MSSI)
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)
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)
Time frame: From Baseline to Months 3, 6, and 9
Changes in depression severity using the Montgomery Asberg Depression Rating Scale (MADRS)
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)
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)
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)
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)
Time frame: From Baseline to Day 35 (Primary Endpoint), Month 6 and Month 9
Safety and tolerability evaluated by Adverse Events
Time frame: Across 9 Months
Safety and tolerability measured by using the Clinician Administered Dissociative Symptom Scale (CADSS)
Time frame: Across 9 months
Safety and tolerability evaluated by the Brief Psychiatric Rating Scale - Positive Symptom Subscale (BPRS-PS)
Time frame: Across 9 months
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 29 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Deep Grewal contact
Joshua D. Rosenblat, MD, MSc principal investigator
Toronto Western Hospital, Psychiatry
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 Ketamine Hydrochloride, Midazolam Hydrochloride and Dialectical Behavioral Therapy (DBT) in people with Borderline Personality Disorder (BPD) and Treatment-Resistant Major Depressive Disorder, run by Joshua Rosenblat at 1 site in Canada.
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: looking for participants now, as of the sponsor's last update on 29 Jul 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 Canada. 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 Diana Orsini (437-882-9458, ket.dbt@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in suicidal ideation severity using the Modified Scale for Suicidal Ideation (MSSI) (time frame: From Baseline to Day 35 (Primary Endpoint)). 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 29 Jul 2026.