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

Washington University School of Medicine1 site in 1 country16 target enrollmentOctober 4, 2023

ConditionsTreatment Resistant Depression

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Treatment Resistant Depression
Sponsor: Washington University School of Medicine
Enrollment: 16
Locations: 1
Primary Endpoint: Remission from Depression
Status: Completed
Last Updated: 6 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 4, 2023

End Date

February 22, 2025

Last Updated

6 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Washington University School of Medicine

Responsible Party

Sponsor

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)

Outcomes

Primary Outcomes

Remission from Depression

Time Frame: Approximately 5 months

Remission defined as Montgomery and Asberg Depression Rating Scale (MADRS) score ≤10. Scale ranges from 0-60 with higher scores indicating higher depression severity.

Secondary Outcomes

SCS-R and UCLA Loneliness Scale(Approximately 5 months)
Visual analogue scale of depressive and anxiety symptoms(Daily following ketamine and therapy sessions during 4 weeks of ketamine-assisted RO DBT)
RewP(Approximately 5 months)
ERN(Approximately 5 months)