Ketamine with DBT for suicidality in adults with treatment-resistant depression or bipolar disorder and BPD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2 trial compares six IV ketamine infusions with DBT to an active placebo (IV midazolam) with DBT in adults aged 18–70 who have BPD and treatment-resistant MDD or BD. Participants receive six infusions and up to six months of DBT, including weekly individual and group sessions. The main goal is to see if ketamine plus DBT produces greater and faster reductions in suicidal ideation than placebo with DBT, using the Modified Scale for Suicidal Ideation (MSSI) from baseline to Day 35. The study uses an active placebo to mask group assignment and evaluate the added benefit of ketamine in this context.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Adults between the age of 18 to 70, inclusive;
2. Meets criteria for BPD, as determined by clinical assessment by a psychiatrist or psychologist and confirmed by the International Personality Disorder Examination (IPDE);
3. 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);
4. 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);
5. No changes in pharmacotherapy for MDD/BD in the last month or changes in psychotherapy in the past month;
6. Baseline SI as shown by two consecutive MSSI scores \> 10 two weeks apart.

Exclusion Criteria:

1. Past or current history of a psychotic disorder as determined by clinical assessment and MINI;
2. Current or recent (within the past 3 months) manic or hypomanic episode as determined by clinical assessment via YMRS (score \> 12) and the MINI;
3. Meeting criteria for Moderate to Severe Alcohol or substance use disorders currently or within the past 3 months;
4. Lifetime history of ketamine use disorder or illicit ketamine use.
5. Acute suicide risk requiring involuntary inpatient treatment under the Mental Health Act (MHA).
6. 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);
7. 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);
8. 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;
9. 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;
10. 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).

Where it's running

• Toronto Western Hospital
  Toronto, Ontario, Canada Recruiting

Study contacts

• Principal investigator: Joshua D. Rosenblat, MD, MSc — Toronto Western Hospital, Psychiatry
• Study coordinator: Diana Orsini
• Email: ket.dbt@uhn.ca
• Phone: 437-882-9458

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.