RecruitingPhase 4interventionalRules rewrite

Phase 4: testing Ketamine for Depression - Major Depressive Disorder

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.

Official registry: https://clinicaltrials.gov/study/NCT07680140 · Weill Medical College of Cornell University · enrollment listed as 27

What this phase means

Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are TMS, or Ketamine. The registry lists allocation as randomized. Depression is one of the leading causes of disability worldwide.

They plan to enroll about 27 people at 2 sites. Taking part typically means taking a study drug (or dummy pill), using or being fitted with a device plus check-ins.

Official title (unrewritten)

Biomarker-Guided Antidepressant Selection for Treatment-Resistant Depression

Interventions: TMS, Ketamine

Primary outcome (registry wording): Change from Baseline to 2-Week Post-Intervention Score in Hamilton Depression Rating Scale (HDRS) Score

Who it is for (from inclusion criteria)

Ages 18 Years to 70 Years
Adults of all genders aged 18-70 at the time of screening
Diagnosis of Major Depressive Disorder (by DSM-5 criteria)
Depressive symptoms of at least moderate severity (GRID HDRS-17 score \>= 14 or as determined by a study clinician)
Not currently taking antidepressants OR on a stable dose of antidepressant for at least 1month prior to screening and plans to remain off antidepressants OR on this stable dose for the duration of participation
Current medication regimen is compatible with safe participation in the trial in the assessment of a study clinician
Access to psychiatric care before, during, and after completion of the study
For females of reproductive potential: agreement to use effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation

Who the registry excludes

Imminent risk of suicide
Presence of primary psychiatric diagnosis other than major depression (e.g., post-traumatic stress disorder, obsessive-compulsive disorder, major depression with psychotic features, primary psychotic illness, bipolar I or II disorder)
History of epilepsy or a history of seizures that would influence the participant's risk for TMS-evoked seizures; history of any condition / concurrent medication that could notably lower seizure threshold in the estimation of a study clinician
Met criteria for any clinically significant substance use disorder (by DSM-V criteria) with active substance misuse in the 6 months prior to screening
Lifetime history of PCP/ketamine abuse
History or presence of significant neurological disorder that may be contributing to current depressive symptoms in the judgment of a study clinician (e.g., traumatic brain injury, stroke, Parkinson's disease or other movement disorder, epilepsy)
Individuals who are nursing, pregnant, or contemplating pregnancy within the length of study participation

Public study contact (from the registry)

Research Coordinator, Interventional Psychiatry Program

646-962-2900

tmsinfo@med.cornell.edu

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

2 listed

Ichan School of Medicine at Mount Sinai — New York, New York (recruiting)
Weill Cornell Medicine — New York, New York (recruiting)

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FAQ about this NCT record

Is NCT07680140 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07680140?

Phase 4. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07680140?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary