Phase 1 N=13 Treatment

KET-RO Plus RO DBT for Treatment Resistant Depression

Treatment Resistant Depression

Bottom Line

View on ClinicalTrials.gov: NCT06138691 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2026

Primary outcome: Primary: Decrease in Depressive Symptoms — 12.13 Score on MADRS — p=0.0065

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: Ketamine Infusion plus RO DBT (Combination_product)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Washington University School of Medicine
Primary completion: Jan 2025

Outcome Measures

Outcome	Result	p-value
PRIMARY Decrease in Depressive Symptoms	12.13	0.0065 sig
SECONDARY Visual Analogue Scale (VAS) of Depressive and Anxiety Symptoms	22.94; 23.69	<0.0001 sig
SECONDARY Reward Positivity (RewP)	0.58	0.6827
SECONDARY Error-related Negativity (ERN)	0.00	.7137
SECONDARY Social Connectedness Scale- Revised (SCS-R)	81.00	0.0024 sig
SECONDARY UCLA Loneliness Scale	34.38	.0015 sig

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 of therapy.

Eligibility Criteria

Inclusion Criteria

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)

Exclusion Criteria

Outside age range
Significant neurological condition (i.e., seizure, stroke, severe head injury) or mental retardation (IQ 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
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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT06138691). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.