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Biomarker-Guided Antidepressant Selection (BioSelect)

25 de junio de 2026 actualizado por: 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.

Descripción general del estudio

Tipo de estudio

Intervencionista

Inscripción (Estimado)

27

Fase

  • Fase 4

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Research Coordinator, Interventional Psychiatry Program
  • Número de teléfono: 646-962-2900
  • Correo electrónico: tmsinfo@med.cornell.edu

Ubicaciones de estudio

    • New York
      • New York, New York, Estados Unidos, 10065
        • Weill Cornell Medicine
        • Investigador principal:
          • Conor Liston, MD, PhD
        • Contacto:
          • Research Coordinator, Interventional Psychiatry Program
          • Número de teléfono: 646-962-2900
          • Correo electrónico: tmsinfo@med.cornell.edu

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Ketamina
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).

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change from Baseline to 2-Week Post-Intervention Score in Hamilton Depression Rating Scale (HDRS) Score
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change from Baseline to Post-Intervention on a Visual Analog Scale of the Antidepressant Selection Approach
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

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

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de julio de 2026

Finalización primaria (Estimado)

1 de septiembre de 2028

Finalización del estudio (Estimado)

1 de diciembre de 2028

Fechas de registro del estudio

Enviado por primera vez

25 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

25 de junio de 2026

Publicado por primera vez (Actual)

2 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

2 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

25 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 26-02029842
  • UG3MH137656 (Subvención/contrato del NIH de EE. UU.)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

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.

Marco de tiempo para compartir IPD

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

Criterios de acceso compartido de IPD

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.

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • CIF

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

Sí

producto fabricado y exportado desde los EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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