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KET-RO Plus RO DBT for Treatment Resistant Depression

Sponsor
Washington University School of Medicine (Other)
Overall Status
Recruiting
CT.gov ID
NCT06138691
Collaborator
(none)
15
Enrollment
1
Location
2
Arms
7.9
Anticipated Duration (Months)
1.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Combination Product: Ketamine Infusion plus RO DBT
 Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
15 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Medication-assisted Psychotherapy: Using Ketamine-enhanced Radically Open Dialectical Behavior Therapy (RO DBT) to Target Neural and Behavioral Mechanisms of Action in Emerging Adults With Moderate to Severe Depression
Actual Study Start Date :
Oct 4, 2023
Anticipated Primary Completion Date :
May 31, 2024
Anticipated Study Completion Date :
May 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Ketamine Infusion

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.
Experimental: Radically Open Dialectical Behavior Therapy (RO DBT)

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.

Outcome Measures

Primary Outcome Measures

  1. Remission from Depression [Approximately 4 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 26 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Males and females aged 18-25

  • 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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Washington University School of Medicine Saint Louis Missouri United States 63110-1010

Sponsors and Collaborators

  • Washington University School of Medicine

Investigators

  • Principal Investigator: Kirsten Gilbert, PhD, Washington University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT06138691
Other Study ID Numbers:
  • 202212113
First Posted:
Nov 18, 2023
Last Update Posted:
Nov 27, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Treatment-Resistant
Ketamine

Study Results

No Results Posted as of Nov 27, 2023