Trial · NCT07569198
Ketamine With Dialectical Behavioural Therapy (DBT) for Suicidality in Individuals With Treatment-Resistant Depression and Borderline Personality Disorder (KET-DBT)
NCT07569198, Phase 2, Recruiting, Joshua Rosenblat
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Ketamine With Dialectical Behavioural Therapy (DBT) for Suicidality in Individuals With Treatment-Resistant Depression and Borderline Personality Disorder (KET-DBT). Trials, record NCT07569198. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07569198
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ketamine With Dialectical Behavioural Therapy (DBT) for Suicidality in Individuals With Treatment-Resistant Depression and Borderline Personality Disorder (KET-DBT)
- NCT number
- NCT07569198
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 120 participants, estimated
- Lead sponsor
- Joshua Rosenblat
- 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, Suicidal Ideation
- Interventions
- Ketamine Hydrochloride, Midazolam Hydrochloride, Dialectical Behavioral Therapy (DBT)
- First posted
- 2026-05-06
- Last updated
- 2026-07-29
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in suicidal ideation severity using the Modified Scale for Suicidal Ideation (MSSI) | 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). |
| Secondary | Changes in suicidal ideation severity over a longer period of time using the Modified Scale for Suicidal Ideation (MSSI) | From Baseline to Month 6 and Month 9 | 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). |
| Secondary | Changes in suicidal behavior (SB) and self-harm (SH) using the Suicide Attempt Self-Injury Interview (SASII) | From Baseline to Months 3, 6, and 9 | 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'). |
| Secondary | Changes in suicidal behavior (SB) and self-harm (SH) using the Lifetime Suicide Attempt Self-Injury Interview (L-SASII) | From Baseline to Months 3, 6, and 9 | The L-SASII will be administered at baseline to obtain a count of lifetime history of suicide attempts and non-suicidal self-injury. |
| Secondary | Changes in depression severity using the Montgomery Asberg Depression Rating Scale (MADRS) | From Baseline to Day 35 (Primary Endpoint), Month 6 and Month 9 | 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. |
| Secondary | Changes in personality psychopathology evaluated using the Borderline Symptom List-23 (BSL-23) | From Baseline to Day 35 (Primary Endpoint), Month 6 and Month 9 | 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. |
| Secondary | Changes in personality psychopathology using Level of Personality Functioning Scale (LPFS) | From Baseline to Day 35 (Primary Endpoint), Month 6 and Month 9 | 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". |
| Secondary | Changes in personality psychopathology using the Symptom-Checklist-90-Revised (SCL-90-R) | From Baseline to Day 35 (Primary Endpoint), Month 6 and Month 9 | 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. |
| Secondary | Changes in anxiety as measured by the Generalized Anxiety Disorder-7 (GAD-7) | From Baseline to Day 35 (Primary Endpoint), Month 6 and Month 9 | 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'). |
| Secondary | Safety and tolerability evaluated by Adverse Events | Across 9 Months | Safety and tolerability will be evaluated by acute and sub-acute treatment-emergent adverse events using standardized adverse effects monitoring. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07569198
GET https://conductscience.org/api/trials/v1/NCT07569198/registered