NCT06138691CompletedPhase 1
KET-RO Plus RO DBT for Treatment Resistant Depression
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
Source: ClinicalTrials.gov · Last updated 30 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 16 (actual)
- First submitted
- 7 Nov 2023
- Start date
- 4 Oct 2023
- Primary completion date
- 11 Jan 2025
- Lead sponsor
- Washington University School of Medicine
- Diseases
- Depression
- NCT number
- NCT06138691
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 16
- From 4 Oct 2023 to the primary completion date, 11 Jan 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of naltrexone, memantine or medication considered contraindicated with ketamine
Other illness
- 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)
- 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
- 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)
Age
- Outside age range
Other
- Taking more than 2 adequately-dosed oral antidepressants
- Inability to understand, speak and read English sufficiently
- Not be pregnant or at risk of becoming pregnant
Who the study is looking for
- 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)
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Washington University School of Medicine Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.