KET-RO Plus RO DBT for Treatment Resistant Depression (KET-RO)

This pilot study (n=15) will assess the safety and feasibility of combining intravenous ketamine with Radically Open Dialectical Behavior Therapy (RO DBT) in young adults with Treatment-Resistant Depression (TRD).

The trial aims to develop and employ innovative methodological approaches to demonstrate the feasibility of precision medicine in this therapy. The trial, conducted by Washington University School of Medicine, involves participants aged 18-65 with moderate to severe persistent depression, characterized by non-delusional major depressive disorder episodes resistant to prior treatments.

Participants will receive either ketamine infusion plus RO DBT or RO DBT alone over a four-month period. The primary outcome measure is remission from depression, defined as a Montgomery and Asberg Depression Rating Scale (MADRS) score of ≤10. Secondary outcome measures include daily assessment of depressive and anxiety symptoms, as well as various neural markers of reward responding and error monitoring.

The study employs a treatment allocation without randomization and is open-label. Enrollment is estimated at 15 participants, with a start date of October 2023 and an estimated completion date of May 2024. Participants must be able to attend in-person therapy sessions and ketamine/therapy visits, among other eligibility criteria.

Topic Treatment-Resistant Depression Depression Adolescence and Psychedelics
Compound Ketamine
Country United States of America
Visit trial
Status Recruiting
Results Published No
Start date 04 October 2023
End date 31 May 2024
Phase Phase I
Design Open
Type Interventional
Generation First
Participants 15
Sex All
Age 18- 65
Therapy Yes

Trial Details

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.

NCT Number NCT06138691

Sponsors & Collaborators

Washington University School of Medicine
Located in St. Louis Missouri, researchers at the Washington University School of Medicine have conducted a number of studies with psychedelics inlcuding ketamine, psilocybin and nitrous oxide.

Data attribution

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