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This pilot study will assess the safety and feasibility of intravenous (IV) ketamine combined with RO DBT in young adults with Treatment-Resistant Depression (TRD). In addition, this study will develop and utilize innovative methodological approaches to demonstrate the feasibility of precision medicine with this type of therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketamine Infusion | Experimental |
| |
| Radically Open Dialectical Behavior Therapy (RO DBT) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketamine Infusion plus RO DBT | Combination Product | The participant will receive 4 weeks of 0.5mg/kg intravenous ketamine given over 40 minutes, as is routinely done in ketamine treatment and four months of RO DBT treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Decrease in Depressive Symptoms | Decrease in depressive symptoms as assessed via the Montgomery and Asberg Depression Rating Scale (MADRS), a clinician-interviewed assessment of depressive symtpoms. Scale ranges from 0-60 with higher scores indicating higher depression severity. | Approximately 5 months |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Scale (VAS) of Depressive and Anxiety Symptoms | Visual analogue sliding scale (0-100) of self-reported ratings of feeling "depressed" or "anxious" in the moment, with higher scores indicating higher depression or anxiety. This visual analogue scale was administered three times: pre-ketamine, 40 minutes post-ketamine and 90 minutes post-ketamine. Reported below is the average rating across all ketamine sessions across the 4 weeks at the 90 minute post-ketamine reported. Units of measure are on the 0 to 100 scale. |
| Measure | Description | Time Frame |
|---|---|---|
| Temporal Experience of Pleasure Scale (TEPS) | The Temporal Experience of Pleasure Scale (TEPS) is a self-report behavioral assessment. This measure assesses anticipatory pleasure and consummatory or outcome pleasure of reward responding into a total score of reward responding, with scores ranging from 18 to 108 with higher scores indicating greater capacity for pleasure and reward. It will examine mechanistic change mid-treatment (post ketamine) and post-treatment; post-treatment scores reported below. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kirsten Gilbert, PhD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110-1010 | United States |
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16 participants were consented and enrolled. However, 3 participants were deemed ineligible at the baseline assessment and did not start treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ketamine + RO DBT | All participants completed 4 weeks of twice weekly ketamine infusions and approximately 4 months of twice weekly RO DBT (individual and skills group/class) concurrently. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Ketamine + RO DBT | All participants completed 4 weeks of RO DBT and approximately 4 months of RO DBT concurrently. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age in years |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Decrease in Depressive Symptoms | Decrease in depressive symptoms as assessed via the Montgomery and Asberg Depression Rating Scale (MADRS), a clinician-interviewed assessment of depressive symtpoms. Scale ranges from 0-60 with higher scores indicating higher depression severity. | 16 participants consented to the study. However, 3 were ineligible at baseline and so did not complete any ketamine or RO DBT treatment. | Posted | Mean | Standard Deviation | Score on MADRS | Approximately 5 months |
|
From enrollment until end of treatment; approximately 5 - 6 months total.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ketamine + RO DBT | 4 weeks of ketamine and approximately 4 months of RO DBT. | 0 |
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The current study had one arm (all participants received treatment). Thus, there is no comparison condition and no randomization occurred as this was a pilot trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kirsten Gilbert, PhD | Washington University in St. Louis | 314-747-0001 | gilbertk@wustl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 26, 2025 | Dec 23, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 11, 2025 | Dec 23, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D061218 | Depressive Disorder, Treatment-Resistant |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| Completed immediately following individual ketamine sessions during 4 weeks of ketamine-assisted RO DBT |
| Reward Positivity (RewP) | The Reward Positivity (RewP) is an electroencephalogram (EEG) based event related potential (ERP) and neural marker of reward responding. During the "Doors Task", a commonly used task to elicit the RewP, participants can win money or lose money when opening doors. The RewP is calculated as the electrical signal in response to winning at electrode Cz on the scalp minus the electrical signal in response to losing at electrode Cz between the timepoints 250-500ms. Thus, it is a difference score of win minus loss response to assess reward response and is measured via microvolts with higher scores indicating a stronger neural response to reward. It will examine change mid-treatment (Post Ketamine) and post treatment. Post-treatment RewP scores reported below. | Immediately post-treatment (approximately 5 months since baseline) |
| Error-related Negativity (ERN) | The erorr-related negativity (ERN) is an electroencephalogram (EEG) based neural marker of error monitoring measured via an event related potential (ERP). It is elicited via Go/No-go tasks where participants make 'correct' responses and 'error' responses. The ERN is calculated as the electrical signal in response to making an error response at Cz on the scalp minus the electrical signal in response to making a correct response at electrode Cz between timepoints 0-50ms. Thus, it is a difference score of error - correct neurla response to assess error or performance monitoring and is measured via microvolts with higher scores indicating a larger response to errors. It will examine change mid-treatment (post ketamine) and post-treatment. Post-treatment ERN scores reported below. | Immediately post-treatment (approximately 5 months since baseline) |
| Social Connectedness Scale- Revised (SCS-R) | The Social Connectedness Scale Revised (SCS-R) is a self-report that assesses interpersonal closeness with a range of scores from 20 to 120, with a higher total score indicating greater social connectedness. This measure will examine mechanistic change mid-treatment (post ketamine) and post-treatment; Post-treatment scores provided below. | Immediately post-treatment (approximately 5 months since baseline) |
| UCLA Loneliness Scale | The UCLA loneliness scale measure social connectedness (or lack of given it assesses perceived loneliness) via self-report with a range of 20 to 80 with higher scores indicating greater loneliness. This measure will examine mechanistic change mid-treatment (post ketamine) and post-treatment; Post-treatment scores provided below. | Immediately post-treatment (approximately 5 months since baseline) |
| Immediately post-treatment (approximately 5 months since baseline) |
| Acceptance and Action Questionnaire--II (AAQ-II) | The Acceptanc and Action Qustionnaire-II (AAQ-II) is a self-reported beahvioral measure of psychological inflexibility with scores ranging from 7 to 49, with higher scores indicating greater psychological inflexibility. It will examine mechanistic change mid-treatment (post-ketamine) and post-treatment; post-treatment scores provided below. | Immediately post-treatment (approximately 5 months since baseline) |
| Standard Deviation |
| age in years |
|
| Sex: Female, Male | Biological sex | 3 participants were ineligible at baseline and did not start therapy. | Count of Participants | Participants |
|
| Race (NIH/OMB) | 3 participants were ineligible at baseline and did not start therapy. | Count of Participants | Participants |
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| Region of Enrollment | St. Louis and surrounding region | Number | Participants |
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| MADRS | Montgomery-Asberg Depression Rating Scale (MADRS) | Mean | Standard Deviation | score on MADRS |
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| Secondary | Visual Analogue Scale (VAS) of Depressive and Anxiety Symptoms | Visual analogue sliding scale (0-100) of self-reported ratings of feeling "depressed" or "anxious" in the moment, with higher scores indicating higher depression or anxiety. This visual analogue scale was administered three times: pre-ketamine, 40 minutes post-ketamine and 90 minutes post-ketamine. Reported below is the average rating across all ketamine sessions across the 4 weeks at the 90 minute post-ketamine reported. Units of measure are on the 0 to 100 scale. | 16 participants consented to the study. However, 3 were ineligible at baseline and so did not complete any ketamine or RO DBT treatment. | Posted | Mean | Standard Deviation | units on a scale | Completed immediately following individual ketamine sessions during 4 weeks of ketamine-assisted RO DBT |
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| Secondary | Reward Positivity (RewP) | The Reward Positivity (RewP) is an electroencephalogram (EEG) based event related potential (ERP) and neural marker of reward responding. During the "Doors Task", a commonly used task to elicit the RewP, participants can win money or lose money when opening doors. The RewP is calculated as the electrical signal in response to winning at electrode Cz on the scalp minus the electrical signal in response to losing at electrode Cz between the timepoints 250-500ms. Thus, it is a difference score of win minus loss response to assess reward response and is measured via microvolts with higher scores indicating a stronger neural response to reward. It will examine change mid-treatment (Post Ketamine) and post treatment. Post-treatment RewP scores reported below. | Posted | Mean | Standard Deviation | uV (microvolts) from EEG | Immediately post-treatment (approximately 5 months since baseline) |
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| Secondary | Error-related Negativity (ERN) | The erorr-related negativity (ERN) is an electroencephalogram (EEG) based neural marker of error monitoring measured via an event related potential (ERP). It is elicited via Go/No-go tasks where participants make 'correct' responses and 'error' responses. The ERN is calculated as the electrical signal in response to making an error response at Cz on the scalp minus the electrical signal in response to making a correct response at electrode Cz between timepoints 0-50ms. Thus, it is a difference score of error - correct neurla response to assess error or performance monitoring and is measured via microvolts with higher scores indicating a larger response to errors. It will examine change mid-treatment (post ketamine) and post-treatment. Post-treatment ERN scores reported below. | 16 participants consented to the study. However, 3 were ineligible at baseline and so did not complete any ketamine or RO DBT treatment. | Posted | Mean | Standard Deviation | uV (microvolts) in EEG signal | Immediately post-treatment (approximately 5 months since baseline) |
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| Secondary | Social Connectedness Scale- Revised (SCS-R) | The Social Connectedness Scale Revised (SCS-R) is a self-report that assesses interpersonal closeness with a range of scores from 20 to 120, with a higher total score indicating greater social connectedness. This measure will examine mechanistic change mid-treatment (post ketamine) and post-treatment; Post-treatment scores provided below. | 16 participants consented to the study. However, 3 were ineligible at baseline and so did not complete any ketamine or RO DBT treatment. | Posted | Mean | Standard Deviation | units on a scaale | Immediately post-treatment (approximately 5 months since baseline) |
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| Other Pre-specified | Temporal Experience of Pleasure Scale (TEPS) | The Temporal Experience of Pleasure Scale (TEPS) is a self-report behavioral assessment. This measure assesses anticipatory pleasure and consummatory or outcome pleasure of reward responding into a total score of reward responding, with scores ranging from 18 to 108 with higher scores indicating greater capacity for pleasure and reward. It will examine mechanistic change mid-treatment (post ketamine) and post-treatment; post-treatment scores reported below. | 16 participants consented to the study. However, 3 were ineligible at baseline and so did not complete any ketamine or RO DBT treatment. | Posted | Mean | Standard Deviation | units on a scale | Immediately post-treatment (approximately 5 months since baseline) |
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| Other Pre-specified | Acceptance and Action Questionnaire--II (AAQ-II) | The Acceptanc and Action Qustionnaire-II (AAQ-II) is a self-reported beahvioral measure of psychological inflexibility with scores ranging from 7 to 49, with higher scores indicating greater psychological inflexibility. It will examine mechanistic change mid-treatment (post-ketamine) and post-treatment; post-treatment scores provided below. | 16 participants consented to the study. However, 3 were ineligible at baseline and so did not complete any ketamine or RO DBT treatment. | Posted | Mean | Standard Deviation | units on a scale | Immediately post-treatment (approximately 5 months since baseline) |
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| Secondary | UCLA Loneliness Scale | The UCLA loneliness scale measure social connectedness (or lack of given it assesses perceived loneliness) via self-report with a range of 20 to 80 with higher scores indicating greater loneliness. This measure will examine mechanistic change mid-treatment (post ketamine) and post-treatment; Post-treatment scores provided below. | 16 participants consented to the study. However, 3 were ineligible at baseline and so did not complete any ketamine or RO DBT treatment. | Posted | Mean | Standard Deviation | units on a scaale | Immediately post-treatment (approximately 5 months since baseline) |
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| Other |
Multilevel models examining change within ketamine sessions |