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Ketamine + DBT for Treatment-Resistant Depression (KET-RO Trial)

Phase 1

Recruiting

Led By Kirsten Gilbert, PhD

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Moderate to severe persistent depression [treatment resistant depression - TRD] (exhibiting 2+ unipolar major depression episodes with prior treatment non-response to antidepressant or psychosocial treatment)

Treatment-resistant depression defined as unipolar major depressive disorder, non-delusional, 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 5 months

Awards & highlights

KET-RO Trial Summary

This trial will study the safety and effectiveness of a new therapy combining ketamine and Dialectical Behavioral Therapy for young adults with severe depression.

Who is the study for?

This trial is for young adults aged 18-25 with Treatment-Resistant Depression, having had at least two major depressive episodes and no response to different antidepressant treatments. Participants must speak English, be able to attend sessions in person, and not have any current psychosis or significant neurological conditions.Check my eligibility

What is being tested?

The study tests the safety and potential effectiveness of Ketamine Infusion combined with RO DBT (a type of therapy) on individuals who haven't responded well to standard depression treatments. It aims to explore precision medicine approaches for treating persistent depression.See study design

What are the potential side effects?

Potential side effects may include increased blood pressure, dissociation during infusion (feeling disconnected from yourself), changes in mood or behavior post-treatment, nausea, dizziness, headache or other infusion-related reactions.

KET-RO Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have severe depression that hasn't improved with treatment.

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My depression hasn't improved after trying two different antidepressants.

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I am between 18 and 25 years old.

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I can go to in-person therapy and ketamine sessions.

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I am willing to undergo RO DBT-A as my only psychological treatment.

KET-RO Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 5 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 5 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 5 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Remission from Depression

Secondary outcome measures

ERN

RewP

SCS-R and UCLA Loneliness Scale

+1 more

Other outcome measures

Action and Acceptance Questionnaire (AAQ)

Temporal Experience of Pleasure Scale (TEPS)

KET-RO Trial Design

2Treatment groups

Experimental Treatment

Group I: Radically Open Dialectical Behavior Therapy (RO DBT)Experimental Treatment1 Intervention

Group II: Ketamine InfusionExperimental Treatment1 Intervention

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor

1,937 Previous Clinical Trials

2,299,680 Total Patients Enrolled

Kirsten Gilbert, PhDPrincipal InvestigatorWashington University School of Medicine

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could I potentially join this research endeavor?

"To be considered for inclusion, candidates must have a major depressive disorder and fall between 18-26 years of age. This medical trial is accepting 15 participants in total."

Answered by AI

Does the eligibility criteria for this trial encompass those aged 40 or older?

"This research is seeking participants that are aged 18-26."

Answered by AI

Are there any current openings in this medical trial that potential participants can apply for?

"Per the data available on clinicaltrials.gov, this experiment is still accepting applications for participants. The trial was first published in October of 2023 and has been updated as recently as November 13th, 2023."

Answered by AI

What potential risks can be associated with Ketamine Infusions?

"The safety of Ketamine Infusion is rated a 1 by Power because this is an initial Phase 1 trial with little supporting evidence in terms of efficacy and security."

Answered by AI

What is the size of the participant population in this experiment?

"Affirmative. Clinicaltrials.gov states that this experiment, which was first published on October 4th 2023, is actively enrolling volunteers. The team needs to find 15 subjects from a single location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

KET-RO Plus RO DBT for Treatment Resistant Depression

Kirsten Gilbert 2023. "KET-RO Plus RO DBT for Treatment Resistant Depression". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06138691.