KET-RO Plus RO DBT for Treatment Resistant Depression

The Washington University

Status and phase

Completed

Phase 1

Conditions

Treatment Resistant Depression

Treatments

Combination Product: Ketamine Infusion plus RO DBT

Study type

Interventional

Funder types

Other

Identifiers

NCT06138691

202212113

Details and patient eligibility

About

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.

Enrollment

16 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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)