Prediction of REsponse to Depression Interventions Using Clinical and TD-fNIRS Measurements

Официальное название

PREDICT: Prediction of REsponse to Depression Interventions Using Clinical and TD-fNIRS Measurements

Обзор

The purpose of the current study is to perform a unified, homogeneous data collection protocol that includes a large cohort of patients undergoing different treatment options for Major Depressive Disorder (MDD) as an avenue for investigating optimal biomarkers for depression treatments on an individual patient level.

Вмешательства

• Другое fNIRS measurement
  Kernel Flow2 measurements.

Первичные конечные точки

• Brain hemodynamic activity with TD-fNIRS [Срок оценки: Approximately 30 minutes during each study visit]
• Optical properties of the brain with TD-fNIRS [Срок оценки: Approximately 30 minutes during each study visit]
• Physiological features with TD-fNIRS [Срок оценки: Approximately 30 minutes during each study visit]
• Physiological features with TD-fNIRS [Срок оценки: Approximately 30 minutes during each study visit]

Вторичные конечные точки (6)

• Montgomery-Åsberg Depression Rating Scale (MADRS) [Срок оценки: At baseline and closeout, up to 3 months]
• Patient Health Questionnaire (PHQ-9) [Срок оценки: From baseline to closeout, up to 3 months]
• General Anxiety Disorder (GAD-7) [Срок оценки: At baseline and closeout, up to 3 months]
• Snaith-Hamilton Pleasure Scale (SHAPS) [Срок оценки: At baseline and closeout, up to 3 months]
• World Health Organization Quality of Life (WHOQOL-BREF) [Срок оценки: At baseline and closeout, up to 3 months]
• Revised Mystical Experience Questionnaire (RMEQ) [Срок оценки: Visit 2, within approximately 7 days of baseline]

Критерии участия

Критерии включения

Ketamine cohort

• Adult between the ages of 18 - 65, inclusive at time of enrollment
• Primary diagnosis of MDD as defined by DSM-5
• Determined by clinic to be eligible for ketamine treatment and agrees to receive ketamine treatment
• Agrees to start ketamine treatment in conjunction with study participation to capture pre-treatment measurements accurately
• Has not received a ketamine treatment course in the past 12 months
• Has not received a TMS treatment course in the past 3 months
• Ability to consent for themselves
• Fluency in English (speaking and reading)

SPRAVATO cohort

• Adult between the ages of 18 - 75, inclusive at time of enrollment
• Primary diagnosis of MDD as defined by DSM-5
• Determined by clinic to be eligible for SPRAVATO treatment and agrees to receive SPRAVATO treatment
• Agrees to start SPRAVATO treatment in conjunction with study participation to capture pre-treatment measurements accurately
• Has not received a ketamine or SPRAVATO treatment course in the past 12 months
• Has not received a TMS treatment course in the past 3 months
• Ability to consent for themselves
• Fluency in English (speaking and reading)

TMS cohort

• Adult between the ages of 18 - 65, inclusive at time of enrollment
• Primary diagnosis of MDD as defined by DSM-5
• Determined by clinic to be eligible for TMS treatment and agrees to receive TMS treatment
• Agrees to start TMS treatment in conjunction with study participation to capture pre-treatment measurements accurately
• Has not received a TMS treatment course in the past 12 months
• Has not received a ketamine or SPRAVATO treatment course within the last 3 months
• Ability to consent for themselves
• Fluency in English (speaking and reading)

Antidepressants cohort

• Adult between the ages of 18 - 65, inclusive at time of enrollment
• Primary diagnosis of MDD as defined by DSM-5
• Determined by clinic to be eligible for antidepressant treatment and agrees to receive antidepressant treatment
• Agrees to start antidepressant treatment in conjunction with study participation to capture pre-treatment measurements accurately
• Has not taken antidepressants in the past 3 months
• Has not received a TMS, SPRAVATO, or ketamine treatment course in the past 3 months
• Ability to consent for themselves
• Fluency in English (speaking and reading)

Критерии исключения

• Is or may be pregnant (for participant of childbearing potential \[POCBP\]), even if they have been cleared to receive the depression treatment
• Unable or unwilling to wear the TD-fNIRS headset
• Has had ECT in the past 3 months
• Major visual or auditory deficits that would prevent study task completion
• Hospitalizations and/or unstable health/medical condition/treatment in the last 30 days
• Major medical illnesses and psychiatric conditions including:

• Alzheimer's/Mild Cognitive Impairment
• Parkinson's disease
• Motor neuron diseases
• Multiple Sclerosis
• Brain Tumor
• Stroke
• Encephalitis
• Meningitis
• Epilepsy
• TBI with serious results (coma, unconscious for >2 hrs, or skull fracture)
• Current serious psychiatric conditions (bipolar disorder, schizophrenia, or psychosis)
• Any other clinically significant medical condition or circumstance that, in the opinion of the Investigator, could affect patient safety, preclude evaluation of response, interfere with the ability to comply with study procedures, or prohibit completion of the study
• Not an appropriate candidate for the study in the judgment of the investigator(s)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 10 центров

• BrainHealth Solutions — Costa Mesa
• Kadima Neuropsychiatry Institute — La Jolla
• Kaizen Brain Center, LLC — La Jolla
• Bespoke Treatment — Los Angeles
• UCLA TMS — Los Angeles
• Bespoke Treatment — Los Angeles
• Acacia Clinics — Sunnyvale
• Metro Psychiatry Inc. — Columbus
• … и ещё 2 центра

Идентификаторы

NCT: NCT06002100 · KER2023-2-PREDICT

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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