NCT06729541Recruiting
Development and Application of 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
Source: ClinicalTrials.gov · Last updated 12 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 600 (estimated)
- First submitted
- 4 Dec 2024
- Start date
- 11 Nov 2024
- Primary completion date
- Jul 2026
- Lead sponsor
- Peking University
- Diseases
- Schizophrenia, Depression, Bipolar disorder
- NCT number
- NCT06729541
What you commit to
- Study type: Interventional
- Planned participants: 600
- From 11 Nov 2024 to the primary completion date, Jul 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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 or unstable physical illnesses;
- A history of epilepsy or seizures;
Other
- 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;
- Narrow-angle glaucoma;
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University Sixth Hostipal Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.