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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
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• 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.

Locations
Other Locations
China
Peking University Sixth Hostipal
RECRUITING
Beijing
Contact Information
Primary
Weihua Yue
dryue@bjmu.edu.cn
86-010-82805307
Time Frame
Start Date: 2024-11-11
Estimated Completion Date: 2026-12
Participants
Target number of participants: 600
Treatments
Experimental: 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
No_intervention: 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.
Related Therapeutic Areas
Sponsors
Leads: Peking University

This content was sourced from clinicaltrials.gov