KET-RO Plus RO DBT for Treatment Resistant Depression (NCT06138691) | Clinical Trial Compass
CompletedPhase 1
KET-RO Plus RO DBT for Treatment Resistant Depression
United States16 participantsStarted 2023-10-04
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 nal…