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NOT YET RECRUITING
NCT07680140
PHASE4

Biomarker-Guided Antidepressant Selection

Sponsor: Weill Medical College of Cornell University

View on ClinicalTrials.gov

Summary

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.

Official title: Biomarker-Guided Antidepressant Selection for Treatment-Resistant Depression

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

27

Start Date

2026-07

Completion Date

2028-12

Last Updated

2026-07-02

Healthy Volunteers

No

Interventions

DEVICE

TMS

rTMS will be administered as intermittent theta burst simulation (iTBS) delivered to the left dorsolateral prefrontal cortex with an accelerated intervention protocol (up to 5 consecutive days of 10 hourly rTMS sessions).

DRUG

Ketamine

Ketamine is a dissociative anesthetic with rapid-acting antidepressant properties. It will be administered in 6 total sessions (3 days x 2 weeks), each comprising a single subanesthetic dose of ketamine (0.5 mg/kg) delivered intravenously over 40 minutes.

Locations (1)

Weill Cornell Medicine

New York, New York, United States