Development and Application of Precision Treatment Strategies for Common Mental Disorders

NCT ID: NCT06729541

Last Updated: 2024-12-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-11
• Study Completion Date: 2026-12-31

Brief Summary

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Guided

In the Guided group, clinicians selected or maintained treatment based on patients' symptoms, incorporating pharmacogenomic testing. Patients underwent pharmacogenomic testing and received the results within 3 to 5 working days. Following this, drug dose adjustments or changes were made within the subsequent week (dose adjustments or changes were completed within 2 weeks of enrollment to ensure a stable dose). For schizophrenia (SCH), antipsychotic monotherapy was employed; for major depressive disorder (MDD), antidepressant monotherapy was initiated; and for bipolar disorder (BPD), mood stabilizer therapy was started with lithium or a single-agent valproic acid salt, along with regular monitoring of blood lithium levels. If symptoms remained uncontrolled after 2 to 4 weeks, consideration was given to adding a second mood stabilizer or psychiatric medication in combination with lithium or valproic acid salt.

After 10 weeks of clinical observation, patients were assessed using standar

Group Type: EXPERIMENTAL

Multigenetic Pharmacogenomics-Guided Treatment (MPGT)

Intervention Type: OTHER

In the guidance group, drug types and dosages were adjusted based on the results of Pharmacogenetic TESTING.

Unguided

In the Unguided group, clinicians selected or maintained treatment based on patients' symptoms, without the use of pharmacogenomic guidance. Patients underwent pharmacogenomic testing, and the results were provided at the end of the 12-week follow-up period. During the 12 weeks of clinical observation, patients were assessed using standardized scales at 4, 8, and 12 weeks. Clinical doctors adjusted the treatment plan based on the patients' clinical manifestations and assessment results at these intervals. The pharmacogenomic test report was delivered to patients at the conclusion of the 12-week follow-up period.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Multigenetic Pharmacogenomics-Guided Treatment (MPGT)

In the guidance group, drug types and dosages were adjusted based on the results of Pharmacogenetic TESTING.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University

OTHER

Sponsor Role: lead

Responsible Party

Weihua Yue

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Peking University Sixth Hostipal

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Weihua Yue

Role: CONTACT

Phone: 86-010-82805307

Email: dryue@bjmu.edu.cn

Facility Contacts

Weihua Yue

Role: primary

Other Identifiers

2024-23

Identifier Type: -

Identifier Source: org_study_id