KET-RO Plus RO DBT for Treatment Resistant Depression

Treatment Resistant Depression Clinical Trial

— KET-RO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06138691
• Other study ID #: 202212113
• Status: Recruiting
• Phase: Phase 1
• Start date: October 4, 2023
• Est. completion date: May 31, 2025

Study information

• Verified date: April 2024
• Source: Washington University School of Medicine
• Contact: Uchechukwu Agali, BS
• Phone: (314) 286-0788
• Email: agali[@]wustl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: May 31, 2025
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Treatment-Resistant
• Treatment Resistant Depression

Intervention

Combination Product:
• 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.

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Temporal Experience of Pleasure Scale (TEPS)	The TEPS is a self-report behavioral assessment, This measure assesses anticipatory pleasure and consummatory or outcome pleasure of reward responding. It will examine mechanistic change mid-treatment (post ketamine) and post-treatment.	Approximately 5 months
Other	Action and Acceptance Questionnaire (AAQ)	The AAQ is a self-reported beahvioral measure of psychological ?exibility. It will examine mechanistic change mid-treatment (post-ketamine) and post-treatment.	Approximately 5 months
Primary	Remission from Depression	Remission defined as Montgomery and Asberg Depression Rating Scale (MADRS) score =10. Scale ranges from 0-60 with higher scores indicating higher depression severity.	Approximately 5 months
Secondary	Visual analogue scale of depressive and anxiety symptoms	Asses daily changes in symptoms following ketamine infusions and RODBT sessions	Daily following ketamine and therapy sessions during 4 weeks of ketamine-assisted RO DBT
Secondary	RewP	The RewP is a neural marker of reward responding and is EEG based. It will examine change id-treatment (Post Ketamine) and post treatment	Approximately 5 months
Secondary	ERN	The ERN is a neural marker of error monitoring and is EEG based. It will examine mechanistic change mid-treatment (post ketamine) and post-treatment.	Approximately 5 months
Secondary	SCS-R and UCLA Loneliness Scale	The Social Connectedness SCale Revised (SCS-R) and the UCLA loneliness scale measure social connectedness (or lack of) via self-report. They will examine mechanistic change mid-treatment (post ketamine) and post-treatment.	Approximately 5 months