Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
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RecruitingPhase 2interventionalRules rewrite

Phase 2: testing Ketamine Hydrochloride for Borderline Personality Disorder (BPD)

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 ?

Official registry: https://clinicaltrials.gov/study/NCT07569198 · Joshua Rosenblat · enrollment listed as 120

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Ketamine Hydrochloride, Midazolam Hydrochloride, or Dialectical Behavioral Therapy (DBT). The registry lists allocation as randomized. 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.

They plan to enroll about 120 people at Toronto. Taking part typically means taking a study drug (or dummy pill), following a program (exercise, therapy, diet, or an app) plus check-ins.

Official title (unrewritten)

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)

Interventions: Ketamine Hydrochloride, Midazolam Hydrochloride, Dialectical Behavioral Therapy (DBT)

Primary outcome (registry wording): Change in suicidal ideation severity using the Modified Scale for Suicidal Ideation (MSSI)

Who it is for (from inclusion criteria)

  • Ages 18 Years to 70 Years
  • 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 major depression 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 major depression/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

Public study contact (from the registry)

Diana Orsini

437-882-9458

ket.dbt@uhn.ca

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

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FAQ about this NCT record

Is NCT07569198 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07569198?

Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07569198?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

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