Biomarker-Guided Antidepressant Selection

Part of paid clinical trials in New York, New York.

Sponsor
Weill Medical College of Cornell University
Study ID
NCT07680140
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Depression - Major Depressive Disorder
  • Ketamine
  • Treatment-resistant Depression (TRD)
  • fMRI
  • rTMS

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • TMS — DEVICE
    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).
  • Ketamine — DRUG
    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.

Study Details

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.

Key Dates

Start date
Jul 31, 2026
Status verified
Jun 2026
Primary completion
Sep 30, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
27 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Repetitive Transcranial Magnetic Stimulation (rTMS)
  • Experimental: Ketamine

Primary Outcome Measure

Change from Baseline to 2-Week Post-Intervention Score in Hamilton Depression Rating Scale (HDRS) Score [ Time Frame: Baseline to 2-weeks post-intervention ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Weill Cornell MedicineNew YorkNew York10065
Research Coordinator, Interventional Psychiatry Program
[email protected]
646-962-2900
Conor Liston, MD, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in New York, NY

By research site
Weill Cornell Medicine· New York, NY

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