Treatment Resistant DepressionPhase 1KET-RONCT06138691
KET-RO Plus RO DBT for Treatment Resistant Depression
A Phase 1 study testing Ketamine Infusion plus RO DBT in people with Treatment Resistant Depression, run by Washington University School of Medicine at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Treatment Resistant Depression
- What is being tested?
- Ketamine Infusion plus RO DBT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Oct 2023to 22 Feb 2025
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females aged 18-65
- Moderate to severe persistent depression [treatment resistant depression - TRD] (exhibiting 2+ unipolar major depression episodes (non-delusional) with prior treatment non-response to antidepressant or psychosocial treatment
- Treatment-resistant depression: defined as unipolar major depressive disorder, non-delusional (diagnosed by SCID-5, Structured Clinical Interview for the DSM ) that persists despite ≥ 2 adequate antidepressant trials of different classes in the current episode; including at least one evidence-based second-line treatment in the current episode (including serotonin norepinephrine reuptake inhibitors, bupropion, tricyclics, monoamine oxidase inhibitors, or augmentation with an atypical antipsychotic, stimulant, bupropion, lithium, or Triiodothyroinine) higher proportion of OC (over controlled) words endorsed compared to UC (Under controlled) words on the Word Pairs Checklist
- no current or past psychosis
- English speaking
- Able to attend in-person behavioral sessions and ketamine/therapy visits
- Willingness to have RO DBT-A as only psychosocial treatment engaged in (medication treatment may continue-but see below for exclusion)
Who cannot join
- Outside age range
- Significant neurological condition (i.e., seizure, stroke, severe head injury) or mental retardation (IQ<70)
- Current or recent substance use disorder, actively suicidal or homicidal (e.g., requires hospitalization)
- Use of naltrexone, memantine or medication considered contraindicated with ketamine
- Baseline systolic BP > 150 systolic or 90 diastolic at evaluation. Participants who initially present with elevated blood pressure may be re-assessed; and if needed, referred to their healthcare provider for hypertension management
- Taking more than 2 adequately-dosed oral antidepressants
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- Inability to understand, speak and read English sufficiently
- Not be pregnant or at risk of becoming pregnant
- Medical conditions or medication usage that in the judgement of the investigators puts the patient at unreasonable safety risk
- First degree relative with a psychotic diagnosis involving hallucinations, delusions, or disorganized thinking and speech (e.g. schizophrenia, schizoaffective disorder, etc)
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110-1010
About this study
Official title: Medication-assisted Psychotherapy: Using Ketamine-enhanced Radically Open Dialectical Behavior Therapy (RO DBT) to Target Neural and Behavioral Mechanisms of Action in Adults With Moderate to Severe Depression
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.
- Conditions
- Treatment Resistant Depression
- Being tested
- Ketamine Infusion plus RO DBT
- Medical subject headings
- Depressive Disorder, Treatment-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketamine Infusion plus RO DBTCombination 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.
| Study group | Role | What they receive |
|---|---|---|
| Ketamine Infusion | Experimental | Not described Receives: Combination Product: Ketamine Infusion plus RO DBT |
| Radically Open Dialectical Behavior Therapy (RO DBT) | Experimental | Not described Receives: Combination Product: Ketamine Infusion plus RO DBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Approximately 5 months
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Immediately post-treatment (approximately 5 months since baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start4 Oct 2023
- Primary completion11 Jan 2025
- Study completion22 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Treatment Resistant DepressionStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kirsten Gilbert, PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06138691
- Sponsor's protocol ID
- 202212113
- Acronym
- KET-RO
- Status last verified
- Mar 2026
- First submitted
- 7 Nov 2023
- Last updated
- 30 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medication-assisted Psychotherapy: Using Ketamine-enhanced Radically Open Dialectical Behavior Therapy (RO DBT) to Target Neural and Behavioral Mechanisms of Action in Adults With Moderate to Severe Depression
- ClinicalTrials.gov ID
- NCT06138691
- Acronym / sponsor ID
- KET-RO / 202212113
- Conditions
- Treatment Resistant Depression
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 4 Oct 2023 (actual)
- Primary completion
- 11 Jan 2025 (actual)
- Study completion
- 22 Feb 2025 (actual)
- First posted
- 18 Nov 2023 (actual)
- Results
- Posted 30 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketamine Infusion | Experimental | Combination Product: Ketamine Infusion plus RO DBT |
| Radically Open Dialectical Behavior Therapy (RO DBT) | Experimental | Combination Product: Ketamine Infusion plus RO DBT |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Males and females aged 18-65
- Moderate to severe persistent depression [treatment resistant depression - TRD] (exhibiting 2+ unipolar major depression episodes (non-delusional) with prior treatment non-response to antidepressant or psychosocial treatment
- Treatment-resistant depression: defined as unipolar major depressive disorder, non-delusional (diagnosed by SCID-5, Structured Clinical Interview for the DSM ) that persists despite ≥ 2 adequate antidepressant trials of different classes in the current episode; including at least one evidence-based second-line treatment in the current episode (including serotonin norepinephrine reuptake inhibitors, bupropion, tricyclics, monoamine oxidase inhibitors, or augmentation with an atypical antipsychotic, stimulant, bupropion, lithium, or Triiodothyroinine) higher proportion of OC (over controlled) words endorsed compared to UC (Under controlled) words on the Word Pairs Checklist
- no current or past psychosis
- English speaking
Key exclusion criteria (10 listed)
- Outside age range
- Significant neurological condition (i.e., seizure, stroke, severe head injury) or mental retardation (IQ<70)
- Current or recent substance use disorder, actively suicidal or homicidal (e.g., requires hospitalization)
- Use of naltrexone, memantine or medication considered contraindicated with ketamine
- Baseline systolic BP > 150 systolic or 90 diastolic at evaluation. Participants who initially present with elevated blood pressure may be re-assessed; and if needed, referred to their healthcare provider for hypertension management
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketamine Infusion plus RO DBTThe 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. | Combination product | Ketamine Infusion, Radically Open Dialectical Behavior Therapy (RO DBT) |
Primary outcome
Decrease in Depressive Symptoms
Time frame: Approximately 5 months
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.
5 secondary outcomes
Visual Analogue Scale (VAS) of Depressive and Anxiety Symptoms
Time frame: Completed immediately following individual ketamine sessions during 4 weeks of ketamine-assisted RO DBT
Reward Positivity (RewP)
Time frame: Immediately post-treatment (approximately 5 months since baseline)
Error-related Negativity (ERN)
Time frame: Immediately post-treatment (approximately 5 months since baseline)
Social Connectedness Scale- Revised (SCS-R)
Time frame: Immediately post-treatment (approximately 5 months since baseline)
UCLA Loneliness Scale
Time frame: Immediately post-treatment (approximately 5 months since baseline)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kirsten Gilbert, PhD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ketamine Infusion plus RO DBT in people with Treatment Resistant Depression, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease in Depressive Symptoms (time frame: Approximately 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.