Washington University School of Medicine
St Louis, Missouri, 63110-1010, United States
NCT Number: NCT06138691
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.
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Notify Me18 year–65 year
All sexes
Interventional
Phase 1
St Louis, Missouri, 63110-1010, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Approximately 5 months
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.
Time frame: Completed immediately following individual ketamine sessions during 4 weeks of ketamine-assisted RO DBT
Visual analogue sliding scale (0-100) of self-reported ratings of feeling "depressed" or "anxious" in the moment, with higher scores indicating higher depression or anxiety. This visual analogue scale was administered three times: pre-ketamine, 40 minutes post-ketamine and 90 minutes post-ketamine. Reported below is the average rating across all ketamine sessions across the 4 weeks at the 90 minute post-ketamine reported. Units of measure are on the 0 to 100 scale.
Time frame: Immediately post-treatment (approximately 5 months since baseline)
The Reward Positivity (RewP) is an electroencephalogram (EEG) based event related potential (ERP) and neural marker of reward responding. During the "Doors Task", a commonly used task to elicit the RewP, participants can win money or lose money when opening doors. The RewP is calculated as the electrical signal in response to winning at electrode Cz on the scalp minus the electrical signal in response to losing at electrode Cz between the timepoints 250-500ms. Thus, it is a difference score of win minus loss response to assess reward response and is measured via microvolts with higher scores indicating a stronger neural response to reward. It will examine change mid-treatment (Post Ketamine) and post treatment. Post-treatment RewP scores reported below.
Time frame: Immediately post-treatment (approximately 5 months since baseline)
The erorr-related negativity (ERN) is an electroencephalogram (EEG) based neural marker of error monitoring measured via an event related potential (ERP). It is elicited via Go/No-go tasks where participants make 'correct' responses and 'error' responses. The ERN is calculated as the electrical signal in response to making an error response at Cz on the scalp minus the electrical signal in response to making a correct response at electrode Cz between timepoints 0-50ms. Thus, it is a difference score of error - correct neurla response to assess error or performance monitoring and is measured via microvolts with higher scores indicating a larger response to errors. It will examine change mid-treatment (post ketamine) and post-treatment. Post-treatment ERN scores reported below.
Time frame: Immediately post-treatment (approximately 5 months since baseline)
The Social Connectedness Scale Revised (SCS-R) is a self-report that assesses interpersonal closeness with a range of scores from 20 to 120, with a higher total score indicating greater social connectedness. This measure will examine mechanistic change mid-treatment (post ketamine) and post-treatment; Post-treatment scores provided below.
Time frame: Immediately post-treatment (approximately 5 months since baseline)
The UCLA loneliness scale measure social connectedness (or lack of given it assesses perceived loneliness) via self-report with a range of 20 to 80 with higher scores indicating greater loneliness. This measure will examine mechanistic change mid-treatment (post ketamine) and post-treatment; Post-treatment scores provided below.
Time frame: Immediately post-treatment (approximately 5 months since baseline)
The Temporal Experience of Pleasure Scale (TEPS) is a self-report behavioral assessment. This measure assesses anticipatory pleasure and consummatory or outcome pleasure of reward responding into a total score of reward responding, with scores ranging from 18 to 108 with higher scores indicating greater capacity for pleasure and reward. It will examine mechanistic change mid-treatment (post ketamine) and post-treatment; post-treatment scores reported below.
Time frame: Immediately post-treatment (approximately 5 months since baseline)
The Acceptanc and Action Qustionnaire-II (AAQ-II) is a self-reported beahvioral measure of psychological inflexibility with scores ranging from 7 to 49, with higher scores indicating greater psychological inflexibility. It will examine mechanistic change mid-treatment (post-ketamine) and post-treatment; post-treatment scores provided below.
Washington University School of Medicine
Other
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
Acronym: KET-RO
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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