Development and Application of Precision Treatment Strategies for Common Mental Disorders

Официальное название

Development and Application of Precision Treatment Strategies for Patients with Depression, Bipolar Disorder, and Schizophrenia: a Multicenter Randomized Controlled Trial

Обзор

Schizophrenia (SCH), major depressive disorder (MDD), and bipolar disorder (BPD) are prevalent, disabling psychiatric conditions that not only cause significant suffering for affected individuals and their families but also impose a substantial socioeconomic burden and challenge societal well-being. Addressing the mental health challenges faced by patients, their families, and the healthcare system is a critical global public health priority. However, a comprehensive and systematic precision treatment approach for mental disorders remains largely absent in current clinical practice. This study leveraged pharmacogenomic insights tailored specifically to the Chinese Han population to guide individualized medication selection. The approach incorporated quantitative assessment-based treatment protocols alongside therapeutic drug monitoring throughout the treatment process. The overarching goal was to establish a systematic precision treatment model that integrates "quantitative assessment-based treatment + pharmacogenomics + therapeutic drug monitoring." This model aims to optimize treatment outcomes, enhance safety, improve efficiency, and reduce costs, ultimately benefiting patients with psychiatric disorders.

Вмешательства

• Другое Multigenetic Pharmacogenomics-Guided Treatment (MPGT)
  In the guidance group, drug types and dosages were adjusted based on the results of Pharmacogenetic TESTING.

Первичные конечные точки

• Change from baseline in Positive and Negative Syndrome Scale (PANSS) [Срок оценки: Weeks 4, 8, and 12 of the treatment duration]
• Change from baseline in Hamilton Depression Rating Scale (HAMD) [Срок оценки: Weeks 4, 8, and 12 of the treatment duration]
• Change from baseline in Young Mania Rating Scale (YMRS) [Срок оценки: Weeks 4, 8, and 12 of the treatment duration]

Вторичные конечные точки (5)

• Clinical Global Impression (CGI) [Срок оценки: Weeks 4, 8, and 12 of the treatment duration]
• Morisky Medication Adherence Scale (MMAS) [Срок оценки: Weeks 4, 8, and 12 of the treatment duration, as well as Months 6 and 12.]
• Plasma Drug Concentration [Срок оценки: Weeks 4, 8, and 12 of the treatment duration]
• Personal and Social Performance Scale (PSP) [Срок оценки: Weeks 4, 8, and 12 of the treatment duration, as well as Months 6 and 12.]
• Safety [Срок оценки: Weeks 4, 8, and 12 of the treatment duration]

Критерии участия

Критерии включения

• Schizophrenia: (1) Age 18-65 years, no gender restriction, Han ethnicity; (2) Diagnosis confirmed using the MINI-International Neuropsychiatric Interview (MINI) tool, meeting the DSM-5 criteria for schizophrenia; (3) Baseline Positive and Negative Syndrome Scale (PANSS) score ≥ 60; (4) Education level of middle school or higher, no language barriers, able to cooperate with assessment and treatment, and informed consent obtained from the patient or guardian.
• Depressive Disorder: (1) Age 18-65 years, no gender restriction, Han ethnicity; (2) Diagnosis confirmed using the MINI tool, meeting the DSM-5 criteria for depressive disorder; (3) Baseline Hamilton Depression Rating Scale (HAMD-17) score ≥ 17; (4) Education level of middle school or higher, no language barriers, able to cooperate with assessment and treatment, and informed consent obtained from the patient or guardian.
• Bipolar Disorder: (1) Age 18-65 years, no gender restriction, Han ethnicity; (2) Diagnosis confirmed using the MINI tool, meeting the DSM-5 criteria for manic or hypomanic episodes in bipolar disorder; (3) Baseline Young Mania Rating Scale (YMRS) score ≥ 13; (4) Education level of middle school or higher, no language barriers, able to cooperate with assessment and treatment, and informed consent obtained from the patient or guardian.

Критерии исключения

• Patients with a history of or currently meeting the DSM-5 criteria for the following diagnoses: organic mental disorders, schizoaffective disorder, intellectual disability, dementia, other cognitive disorders, alcohol or drug dependence, and Axis II disorders including personality disorders;
• Patients with severe suicidal tendencies (as assessed by the MINI Chinese version suicide module with a moderate risk or higher), or those at risk of harming others;
• Patients with severe or unstable physical illnesses;
• Narrow-angle glaucoma;
• A history of epilepsy or seizures;
• Known pregnancy and/or breastfeeding, or those planning to become pregnant;
• Participation in another clinical trial, or unwilling or unable to complete the full course of this trial;
• Participants deemed unsuitable by the investigator.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Peking University Sixth Hostipal — Пекин

Идентификаторы

NCT: NCT06729541 · 2024-23

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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