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Clinical Trials/NCT06138691
NCT06138691CompletedPhase 1

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 enrollmentStarted: October 4, 2023Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
16
Locations
1
Primary Endpoint
Decrease in Depressive Symptoms
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study 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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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)

Arms & Interventions

Radically Open Dialectical Behavior Therapy (RO DBT)

Experimental

Intervention: Ketamine Infusion plus RO DBT (Combination Product)

Ketamine Infusion

Experimental

Intervention: Ketamine Infusion plus RO DBT (Combination Product)

Outcomes

Primary Outcomes

Decrease in Depressive Symptoms

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.

Secondary Outcomes

  • Visual Analogue Scale (VAS) of Depressive and Anxiety Symptoms(Completed immediately following individual ketamine sessions during 4 weeks of ketamine-assisted RO DBT)
  • Reward Positivity (RewP)(Immediately post-treatment (approximately 5 months since baseline))
  • Error-related Negativity (ERN)(Immediately post-treatment (approximately 5 months since baseline))
  • Social Connectedness Scale- Revised (SCS-R)(Immediately post-treatment (approximately 5 months since baseline))
  • UCLA Loneliness Scale(Immediately post-treatment (approximately 5 months since baseline))

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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