Status:
COMPLETED
KET-RO Plus RO DBT for Treatment Resistant Depression
Lead Sponsor:
Washington University School of Medicine
Conditions:
Treatment Resistant Depression
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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 develo...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
October 4 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 22 2025
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT06138691
Start Date
October 4 2023
End Date
February 22 2025
Last Update
October 21 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Washington University School of Medicine
St Louis, Missouri, United States, 63110-1010