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Biomarker-Guided Antidepressant Selection (BioSelect)

25. Juni 2026 aktualisiert von: Weill Medical College of Cornell University

Biomarker-Guided Antidepressant Selection for Treatment-Resistant Depression

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.

Studienübersicht

Studientyp

Interventionell

Einschreibung (Geschätzt)

27

Phase

  • Phase 4

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

  • Name: Research Coordinator, Interventional Psychiatry Program
  • Telefonnummer: 646-962-2900
  • E-Mail: tmsinfo@med.cornell.edu

Studienorte

    • New York
      • New York, New York, Vereinigte Staaten, 10065
        • Weill Cornell Medicine
        • Hauptermittler:
          • Conor Liston, MD, PhD
        • Kontakt:
          • Research Coordinator, Interventional Psychiatry Program
          • Telefonnummer: 646-962-2900
          • E-Mail: tmsinfo@med.cornell.edu

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Inclusion Criteria:

  1. Provision of signed and dated informed consent form
  2. Adults of all genders aged 18-70 at the time of screening
  3. Diagnosis of Major Depressive Disorder (by DSM-5 criteria)
  4. Depressive symptoms of at least moderate severity (GRID HDRS-17 score >= 14 or as determined by a study clinician)
  5. Failed at least 1 prior trial of standard first-line treatment for MDD per the modified Antidepressant Treatment History form, the Maudsley Staging Method, and APA Practice Guidelines (e.g., SSRI, SNRI, CBT) OR initiated and discontinued a trial of a first-line treatment for MDD (e.g. could not tolerate side effects, etc.)
  6. 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
  7. Current medication regimen is compatible with safe participation in the trial in the assessment of a study clinician
  8. Access to psychiatric care before, during, and after completion of the study
  9. 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
  10. Proficiency in English sufficient to complete assessments and follow study procedure instructions
  11. Stated willingness to comply with all study procedures and availability for the duration of the study

Exclusion Criteria:

  1. Imminent risk of suicide
  2. Presence of primary psychiatric diagnosis other than MDD (e.g., post-traumatic stress disorder, obsessive-compulsive disorder, MDD with psychotic features, primary psychotic illness, bipolar I or II disorder)
  3. 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
  4. Met criteria for any clinically significant substance use disorder (by DSM-V criteria) with active substance misuse in the 6 months prior to screening
  5. Lifetime history of PCP/ketamine abuse
  6. 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)
  7. Presence of medical contraindications to ketamine, including liver function tests > 2.5x normal limit, recent myocardial infarction, congestive heart failure > stage 2, angina pectoris, clinically significant bradycardia or tachycardia at the baseline assessment, or uncontrolled hypertension
  8. MRI contraindication, including presence of ferromagnetic foreign metal bodies or implants, implanted or conductive ferromagnetic objects in or near the head (e.g., stents, deep brain stimulators, vagus nerve stimulators, aneurysm coils, ocular implants, cochlear implants), and ferromagnetic permanent make-up that may undergo heating in an MRI scanner
  9. Individuals who are nursing, pregnant, or contemplating pregnancy within the length of study participation
  10. Abnormal bloodwork that may be contributing to depressive symptoms in the estimation of a study clinician (e.g. indicators of clinically significant hypothyroidism, kidney failure, liver failure, etc.)
  11. History or presence of any disorder or medical condition that, in the opinion of the study team, may compromise, interfere, or limit the individual's ability to complete the intervention or study procedures

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Ketamin
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.
Experimental: Repetitive Transcranial Magnetic Stimulation (rTMS)
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).

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change from Baseline to 2-Week Post-Intervention Score in Hamilton Depression Rating Scale (HDRS) Score
Zeitfenster: Baseline to 2-weeks post-intervention
Change in depressive symptoms from pre- to post-intervention, as measured by mean percent change in score on the GRID 17-item Hamilton Depression Rating Scale (HDRS-17), in participants receiving rTMS vs. ketamine. The GRID HDRS-17 has a minimum score of 0 and maximum score of 52, with higher scores indicating greater depression severity.
Baseline to 2-weeks post-intervention

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change from Baseline to Post-Intervention on a Visual Analog Scale of the Antidepressant Selection Approach
Zeitfenster: From screening to the end of follow-up at 8-weeks post-intervention
Ratings on a visual analog scale assessing whether the study visits (including MRI scans and clinical assessments) are tolerable and perceived to be an acceptable component of future intervention protocols. The scale will be scored from -10 to +10, with higher scores indicating higher acceptability. Secondary outcome analyses will use a one-sample t-test to evaluate whether visual analog scores are significantly greater than zero.
From screening to the end of follow-up at 8-weeks post-intervention

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Ermittler

  • Hauptermittler: Conor Liston, MD, PhD, Weill Medical College of Cornell University

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Juli 2026

Primärer Abschluss (Geschätzt)

1. September 2028

Studienabschluss (Geschätzt)

1. Dezember 2028

Studienanmeldedaten

Zuerst eingereicht

25. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

25. Juni 2026

Zuerst gepostet (Tatsächlich)

2. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

2. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

25. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

Individual participant data that underlie the results reported in the primary outcomes publication, after de-identification, will be shared. Supporting documents including the study protocol and informed consent form will be available. Analytic pipelines used in published analyses will be made publicly available via GitHub.

IPD-Sharing-Zeitrahmen

IPD will be available to researchers who provide a methodologically sound proposal, beginning 6 months and ending 6 years following article publication.

IPD-Sharing-Zugriffskriterien

De-identified IPD provided in the primary outcomes publication may be provided to qualified researchers who submit a methodologically sound proposal to the study PI. To gain access, data requestors will need to sign a data sharing agreement. Data will shared via a secure, encrypted file transfer system.

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • ICF

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Ja

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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