A Novel Blood Test as a Biomarker in Mental Health
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Depression - Major Depressive Disorder, Schizophenia Disorder, Psychosis, Mania (Neurotic). Базовые параметры: от 19 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Канада
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
A Novel Blood Test as a Differential Diagnosis and Drug Efficacy Biomarker in Mental Health
Обзор
This longitudinal, observational study aims to assess whether the characteristics of a novel blood peripheral biomarker can serve as indicators for depression and schizophrenia in patients at the Royal Columbian Hospital Psychiatric Clinics. The study will evaluate whether changes in these biomarker characteristics can help distinguish between depressed patients who do or do not respond to treatment and between individuals experiencing a single psychotic episode and those at risk of progressing to schizophrenia. To achieve this, blood samples and standardized mental health assessments will be collected across three study visits from up to 500 participants, grouped into two study arms based on their diagnosis: Depression (DEP) or Psychosis/Schizophrenia (PSY).
Первичные конечные точки
- Relationship between Depression and Biomarker Characteristics [Срок оценки: 6 months from enrollment, across three study visits.]
- Relationship between Psychotic Disorders and Biomarker Characteristics [Срок оценки: 6 months from enrollment, across 3 study visits.]
Вторичные конечные точки (3)
- Association between Clinical-Demographic Factors and Biomarker Characteristics. [Срок оценки: 6 months from enrollment, across 3 study visits.]
- Relationship between PSY arm Clinical-Demographic Factors and Biomarker Characteristics. [Срок оценки: 6 months from enrollment, across 3 study visits.]
- Association between Psychotic Disorders Pharmacological Treatment and Biomarker Characteristics [Срок оценки: 6 months from enrollment, across 3 study visits.]
Критерии участия
Критерии включения
I. Age 19+. II. Informed consent by participant
III. Any of the following situations:
- Suspected, new onset or established depression.
- First episode of psychosis or suspected/established schizophrenia. IV. In the opinion of the Investigator, the participant will likely be able to complete the standardized mental health questionnaires administered in each study visit.
Критерии исключения
I. Inability to provide informed consent. II. Currently enrolled in any other research study involving drugs or devices that may confound mental health treatment outcomes.
III. Currently declared on extended leave Under British Columbia's Mental Health Act.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Канада · 1 центр
- Royal Columbian Hospital — New Westminster
Публикации
- Romay-Tallon R, Kulhawy E, Brymer KJ, Allen J, Rivera-Baltanas T, Olivares JM, Kalynchuk LE, Caruncho HJ. Changes in Membrane Protein Clustering in Peripheral Lymphocytes in an Animal Model of Depression Parallel Those Observed in Naive Depression Patients: Implications for the Development of Novel Biomarkers of Depression. Front Pharmacol. 2018 Oct 15;9:1149. doi: 10.3389/fphar.2018.01149. eColle PMID 30374301
- Rodrigues-Amorim D, Rivera-Baltanas T, Lopez M, Spuch C, Olivares JM, Agis-Balboa RC. Schizophrenia: A review of potential biomarkers. J Psychiatr Res. 2017 Oct;93:37-49. doi: 10.1016/j.jpsychires.2017.05.009. Epub 2017 May 26. PMID 28578207
- Rivera-Baltanas T, Olivares JM, Martinez-Villamarin JR, Fenton EY, Kalynchuk LE, Caruncho HJ. Serotonin 2A receptor clustering in peripheral lymphocytes is altered in major depression and may be a biomarker of therapeutic efficacy. J Affect Disord. 2014 Jul;163:47-55. doi: 10.1016/j.jad.2014.03.011. Epub 2014 Apr 3. PMID 24836087
- Rivera-Baltanas T, Olivares JM, Calado-Otero M, Kalynchuk LE, Martinez-Villamarin JR, Caruncho HJ. Serotonin transporter clustering in blood lymphocytes as a putative biomarker of therapeutic efficacy in major depressive disorder. J Affect Disord. 2012 Mar;137(1-3):46-55. doi: 10.1016/j.jad.2011.12.041. Epub 2012 Jan 16. PMID 22257570
- Rivera-Baltanas T, Agis-Balboa RC, Romay-Tallon R, Kalynchuk LE, Olivares JM, Caruncho HJ. Serotonin transporter clustering in blood lymphocytes predicts the outcome on anhedonia scores in naive depressive patients treated with antidepressant medication. Ann Gen Psychiatry. 2015 Dec 21;14:45. doi: 10.1186/s12991-015-0085-8. eCollection 2015. PMID 26697099
- Rangaswamy T, Mangala R, Mohan G, Joseph J, John S. Intervention for first episode psychosis in India - The SCARF experience. Asian J Psychiatr. 2012 Mar;5(1):58-62. doi: 10.1016/j.ajp.2012.01.011. Epub 2012 Mar 3. PMID 26878950
- Peterson BS. Editorial: Biomarkers in precision medicine for mental illnesses. J Child Psychol Psychiatry. 2020 Dec;61(12):1279-1281. doi: 10.1111/jcpp.13357. PMID 33252151
- Orsolini L, Pompili S, Tempia Valenta S, Salvi V, Volpe U. C-Reactive Protein as a Biomarker for Major Depressive Disorder? Int J Mol Sci. 2022 Jan 30;23(3):1616. doi: 10.3390/ijms23031616. PMID 35163538
Идентификаторы
NCT: NCT06856161 · FHREB 2024-143