Precision treatment strategies for common mental disorders
Development and Application of Precision Treatment Strategies for Patients with Depression, Bipolar Disorder, and Schizophrenia: a Multicenter Randomized Controlled Trial
This study is testing a personalized approach to treating common mental health conditions like depression and schizophrenia by using genetic information to help choose the right medications for people.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Peking University Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06729541 on ClinicalTrials.gov |
What this trial studies
This study focuses on developing and applying precision treatment strategies for prevalent psychiatric conditions such as schizophrenia, major depressive disorder, and bipolar disorder. It utilizes pharmacogenomic insights tailored to the Chinese Han population to guide individualized medication selection. The approach includes quantitative assessments and therapeutic drug monitoring throughout the treatment process, aiming to create a systematic model for precision treatment in mental health. The study seeks to address the significant burden these disorders impose on individuals and society.
Who should consider this trial
Good fit: Ideal candidates for this study are Han ethnicity individuals aged 18-65 diagnosed with schizophrenia, major depressive disorder, or bipolar disorder.
Not a fit: Patients outside the Han ethnicity or those with severe comorbid conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective and personalized treatment options for patients with common mental disorders.
How similar studies have performed: Other studies have shown promise in using pharmacogenomics for mental health treatment, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Beijing, Beijing Municipality
- Peking University Sixth Hostipal — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Weihua Yue
- Email: dryue@bjmu.edu.cn
- Phone: 86-010-82805307
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.