KET-RO Plus RO DBT for Treatment Resistant Depression

NCT ID: NCT06138691

Last Updated: 2025-10-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-04
• Study Completion Date: 2025-02-22

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ketamine Infusion

Group Type: EXPERIMENTAL

Ketamine Infusion plus RO DBT

Intervention Type: 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.

Radically Open Dialectical Behavior Therapy (RO DBT)

Group Type: EXPERIMENTAL

Ketamine Infusion plus RO DBT

Intervention Type: 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.

Interventions

Ketamine Infusion plus RO DBT

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.

Intervention Type: COMBINATION_PRODUCT

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<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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kirsten Gilbert, PhD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Washington University School of Medicine

St Louis, Missouri, United States

Countries

United States

Other Identifiers

202212113

Identifier Type: -

Identifier Source: org_study_id