Clinical trial for Borderline Personality Disorder (BPD)
Official title Ketamine With Dialectical Behavioural Therapy (DBT) for Suicidality in Individuals With Treatment-Resistant Depression and Borderline Personality Disorder (KET-DBT)
ClinicalTrials.gov ID: NCT07569198
What this study is testing
What is Ketamine Hydrochloride?
Ketamine Hydrochloride is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for borderline personality disorder (bpd).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 ?
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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...
- 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...
- Current MDE must be moderate to severe, as determined by the MADRS score \>20 with an inadequate response to two or more guideline-concordant...
- No changes in pharmacotherapy for MDD/BD in the last month or changes in psychotherapy in the past month;
You likely can't join if
- 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...
See the full eligibility criteria
- 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...
- 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...
- 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.
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Compensation & support
This study's listing mentions compensation or reimbursement.
No amount is published here - ClinicalTrials.gov has no reliable field for payment or travel support. Ask the study team what's actually covered (payment for your time, travel, parking, or other study costs), and never join a trial for the compensation alone.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.