Borderline Personality Disorder study: Ketamine Hydrochloride vs Midazolam Hydrochloride
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?
This is an investigational medicine being studied to see if it helps reduce suicidal thoughts in people with Borderline Personality Disorder. It is designed to block certain brain signals that carry pain and other sensations, which may help change how the brain processes mood and stress.
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
- This study aims to find out if combining IV ketamine with a specific type of talk therapy works better than a look-alike drug and therapy for reducing suicidal thoughts.
- Who it's for
- The study is looking for adults with borderline personality disorder and either major depression or bipolar disorder who are currently having suicidal thoughts.
- What's involved
- Participants will receive six IV infusions of either ketamine or a look-alike drug. They will also attend six months of therapy, including weekly one-on-one sessions and group sessions.
- Time commitment
- The study lasts about six months and requires scheduled in-person hospital visits, remote video calls, and regular mood and behavior assessments.
- 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.
- 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.
- 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).
The study team makes the final eligibility decision.
Where it is enrolling
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, but 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?
This study is enrolling now at Toronto, Ontario, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.