Recruiting

Development and Application of Precision Treatment Strategies for Common Mental Disorders

ClinicalTrials.gov IDNCT06729541

PhaseNA

Enrollment600

SponsorPeking University

Age18 Years

SexALL

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Conditions studied

Depression - Major Depressive Disorder, Schizophrenia Disorders, Bipolar Disorder (BD)

About this study

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.

Interventions

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

Primary outcomes

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

Eligibility information

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Study locations

Peking University Sixth Hostipal, Beijing, Beijing Municipality 100191 China

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.