Trial · NCT06480500
i-CBT and IV Ketamine for Suicidality in Treatment-Resistant Depression: A Randomized, Midazolam-Controlled Clinical Trial
NCT06480500, Phase 2, Active not recruiting, University Health Network, Toronto
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. i-CBT and IV Ketamine for Suicidality in Treatment-Resistant Depression: A Randomized, Midazolam-Controlled Clinical Trial. Trials, record NCT06480500. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06480500
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- i-CBT and IV Ketamine for Suicidality in Treatment-Resistant Depression: A Randomized, Midazolam-Controlled Clinical Trial
- NCT number
- NCT06480500
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 76 participants, estimated
- Lead sponsor
- University Health Network, Toronto
- Conditions
- Major Depressive Disorder, Suicide, Treatment Resistant Depression
- Interventions
- Ketamine hydrochloride, i-CBT (Internet-based Cognitive Behavioural Therapy), Midazolam Hydrochloride
- First posted
- 2024-06-28
- Last updated
- 2026-10-06
Source ClinicalTrials.gov
Registered outcomes33
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Suicidality severity using the Columbia-Suicide Severity Rating Scale (C-SSRS) | 30 Days, up to 91 Days. | The CSSRS evaluates suicidal ideation and behaviour. The CSSRS evaluates suicidal ideation and behaviour. The suicidal ideation score ranges from 0 (no ideation) to 5 (active suicidal ideation with specific plan and intent). Suicidal ideation intensity score ranges from 0 (no ideation) to 25 (most severe). The presence of suicidal behaviour is rated as a binary response; the lethality of actual attempts are rated on a scale of 0 (no or very minor physical damage) to 5 (death) and the potential lethality of actual attempts are rated on a scale of 0 (behaviour not likely to result in injury) to 2 (behaviour likely to result in death despite available medical care). |
| Secondary | Objective Depressive Symptom Severity using the Montgomery-Asberg Depression Rating Scale (MADRS) | Day 30, Day 91 | The MADRS is a scale measuring objective depression severity, consisting of 10 items, each scored from 0 (normal) to 6 (severe), for a total possible score of 60; higher scores denote greater severity. |
| Secondary | Subjective Depressive Symptom Severity using the McIntyre and Rosenblat Rapid Response Scale (MARRRS) | Day 30, Day 91 | The MARRRS is a self-reported 14-item self-report measure of depressive symptoms present during the past 72 hours. Total score ranges from 0 to 42; a higher score indicates greater symptom severity. |
| Secondary | Subjective Depressive Symptom Severity using Quick Inventory for Depressive Symptomatology, Self-Report, 16-item (QIDS-SR-16) | Day 30, Day 91 | The QIDS-SR-16 total score ranges from 0 to 27 with 0 representing no depression and 27 representing severe depression. |
| Secondary | Symptom Severity and Treatment response using the Clinical Global Impressions Scale (CGI) | Day 30, Day 91 | The CGI severity module assesses the severity of a person's depressive illness using a seven-point Likert scale, ranging from "Normal, not at all depressed" to "Among the most extremely depressed patients". The CGI improvement module evaluates the global improvement of a person's condition since their last visit on a seven-point Likert scale, ranging from "Very much improved" to "Very much worse". |
| Secondary | Dissociative Symptom Severity using the Clinician-Administered Dissociative States Scale (CADSS), 23-item | 30 minutes Post-Infusion | The CADSS measures objective dissociative symptom severity post infusion. Total scores on the 23-item CADSS range from 0 to 92; a higher score denotes greater dissociative symptom severity. |
| Secondary | Treatment-Emergent Psychiatric Symptoms using the Brief Psychiatric Rating Scale (BPRS) | 30 minutes Post infusion, Day 30, Day 91 | The BPRS rating scale has 18 items, each item rated on a severity scale of 1 (not present) to 7 (extremely severe). 0 is entered if the item is not assessed. |
| Secondary | Treatment-Emergent Manic Symptoms using the Young Mania Rating Scale (YMRS) | 30 minutes Post infusion, Day 30, Day 91 | The Young Mania Rating Scale (YMRS) is a clinical interview scale to assess the severity of manic states and in this study to look at treatment-emergent mania. Total scores range from 0 to 60, with higher scores indicative of greater symptom severity. |
| Secondary | Mystical Type Experiences using the Mystical Experiences Questionnaire (MEQ) | 30 minutes Post Infusion, Day 30, Day 91 | The MEQ consists of 30 items, each item rated on a Likert scale (0-None/not at all to 5-Extreme, more than any other time in my life). The MEQ total score is computed by taking the average response to all items. |
| Secondary | Subjective Wellbeing using the World Health Organization-5 Well-Being Index (WHO-5) | Day 30, Day 91 | The WHO-5 is a measure of overall well-being, rated on a scale of 0 to 25, with higher scores denoting higher quality of life. |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 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.
Tests7
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Choice Reaction Time | Secondary outcome | ConductCognition |
| Implicit Association Test (IAT) | Secondary outcome | ConductCognition |
| Symbol Coding | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
| Verbal Fluency | Secondary outcome | ConductCognition |
| Verbal Learning | Secondary outcome | ConductCognition |
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/NCT06480500
GET https://conductscience.org/api/trials/v1/NCT06480500/registered?page=2