TMS + Ketamine for Depression

(BioSelect Trial)

Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: Weill Medical College of Cornell University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

Depression is one of the leading causes of disability worldwide. Common treatments like antidepressant medications and talk therapy work well for some people, but many others do not improve, even after trying multiple treatments.

This study will investigate two alternative treatment options for people whose depression has not responded to standard treatments: repetitive transcranial magnetic stimulation (rTMS), a non-invasive form of brain stimulation, and ketamine, a fast-acting medication. It can be difficult to decide between these interventions in clinical practice, and selecting between them often comes down to patient preference and trial and error. This study is working to optimize the selection approach: using biological and behavioral markers to match each person to identify biomarkers that may predict response to rTMS or ketamine. Investigators believe that differences in how individuals respond to rTMS versus ketamine are partly explained by differences in how their brains are organized, and that these differences can be measured and used to guide intervention decisions. This is an early-stage pilot study designed to test whether this biomarker-based approach is practical and acceptable to patients. Investigators will evaluate how well a combination of brain imaging and clinical data can predict, at the individual level, who is likely to respond to rTMS versus ketamine. The ultimate goal is to develop a reliable, scalable tool that helps clinicians make faster and more informed intervention decisions, reducing the time people with treatment-resistant depression spend searching for an antidepressant that works.

Who Is on the Research Team?

CL

Conor Liston, MD, PhD

Principal Investigator

Weill Medical College of Cornell University

Are You a Good Fit for This Trial?

This trial is for adults with depression that hasn't improved after trying standard treatments. Participants should be able to undergo brain imaging and not have medical conditions or implants that would make rTMS or ketamine unsafe.

Inclusion Criteria

Provision of signed and dated informed consent form
I have moderate or more severe depression symptoms.
Proficiency in English sufficient to complete assessments and follow study procedure instructions
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Exclusion Criteria

Presence of primary psychiatric diagnosis other than MDD (e.g., PTSD, OCD, MDD with psychotic features, primary psychotic illness, bipolar I or II disorder)
MRI contraindications including ferromagnetic foreign metal bodies or implants, implanted or conductive ferromagnetic objects in or near the head, and ferromagnetic permanent make-up that may heat in MRI scanner
Individuals who are nursing, pregnant, or contemplating pregnancy during study participation
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What Are the Treatments Tested in This Trial?

Interventions

  • Ketamine
  • Repetitive Transcranial Magnetic Stimulation (rTMS)

Trial Overview

The study compares two alternative depression treatments: repetitive transcranial magnetic stimulation (rTMS) and ketamine. Researchers use brain scans and clinical data to see if they can predict which treatment will work best for each person.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Repetitive Transcranial Magnetic Stimulation (rTMS)Experimental Treatment1 Intervention
Group II: KetamineExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials
1,103
Recruited
1,157,000+

Icahn School of Medicine at Mount Sinai

Collaborator

Trials
933
Recruited
579,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials
3,007
Recruited
2,852,000+