Development and Application of Precision Treatment Strategies for Common Mental Disorders
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Multigenetic Pharmacogenomics-Guided Treatment (MPGT).
- Who it may be relevant to
- Registry conditions: Depression - Major Depressive Disorder, Schizophrenia Disorders, Bipolar Disorder (BD). Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Development and Application of Precision Treatment Strategies for Patients with Depression, Bipolar Disorder, and Schizophrenia: a Multicenter Randomized Controlled Trial
Overview
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 outcome measures
- Change from baseline in Positive and Negative Syndrome Scale (PANSS) [Time frame: Weeks 4, 8, and 12 of the treatment duration]
- Change from baseline in Hamilton Depression Rating Scale (HAMD) [Time frame: Weeks 4, 8, and 12 of the treatment duration]
- Change from baseline in Young Mania Rating Scale (YMRS) [Time frame: Weeks 4, 8, and 12 of the treatment duration]
Secondary outcome measures (5)
- Clinical Global Impression (CGI) [Time frame: Weeks 4, 8, and 12 of the treatment duration]
- Morisky Medication Adherence Scale (MMAS) [Time frame: Weeks 4, 8, and 12 of the treatment duration, as well as Months 6 and 12.]
- Plasma Drug Concentration [Time frame: Weeks 4, 8, and 12 of the treatment duration]
- Personal and Social Performance Scale (PSP) [Time frame: Weeks 4, 8, and 12 of the treatment duration, as well as Months 6 and 12.]
- Safety [Time frame: Weeks 4, 8, and 12 of the treatment duration]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Peking University Sixth Hostipal — Beijing
Identifiers
NCT: NCT06729541 · 2024-23