KET-RO Plus RO DBT for Treatment Resistant Depression

NCT06138691 | Completed Phase 1 Results FDA Drug

• 1 other identifier: 202212113
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Treatment Resistant Depression

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Visual Analogue Scale (VAS) of Depressive and Anxiety Symptoms

  Completed immediately following individual ketamine sessions during 4 weeks of ketamine-assisted RO DBT

• Reward Positivity (RewP)

  Immediately post-treatment (approximately 5 months since baseline)

• Error-related Negativity (ERN)

  Immediately post-treatment (approximately 5 months since baseline)

• Social Connectedness Scale- Revised (SCS-R)

  Immediately post-treatment (approximately 5 months since baseline)

• UCLA Loneliness Scale

  Immediately post-treatment (approximately 5 months since baseline)

Other Outcomes (2)

• Temporal Experience of Pleasure Scale (TEPS)

  Immediately post-treatment (approximately 5 months since baseline)

• Acceptance and Action Questionnaire--II (AAQ-II)

  Immediately post-treatment (approximately 5 months since baseline)

Study Arms (2)

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

Interventions

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.

Ketamine Infusion; Radically Open Dialectical Behavior Therapy (RO DBT)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110-1010, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Limitations and Caveats

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.

Results Point of Contact

• Title: Kirsten Gilbert, PhD
• Organization: Washington University in St. Louis

gilbertk@wustl.edu

314-747-0001

Study Officials

• Kirsten Gilbert, PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2023
• First Posted: November 18, 2023
• Study Start: October 4, 2023
• Primary Completion: January 11, 2025
• Study Completion: February 22, 2025
• Last Updated: March 30, 2026
• Results First Posted: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)