Clinical trial NCT06729541: Development and Application of Precision Treatment Strategies for Common Mental Disorders
Official title: Development and Application of Precision Treatment Strategies for Patients with Depression, Bipolar Disorder, and Schizophrenia: a Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression - Major Depressive Disorder
Schizophrenia Disorders
Bipolar Disorder (BD)
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2024-12-11
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change from baseline in Positive and Negative Syndrome Scale (PANSS)
timeFrame: Weeks 4, 8, and 12 of the treatment duration
measure: Change from baseline in Hamilton Depression Rating Scale (HAMD)
timeFrame: Weeks 4, 8, and 12 of the treatment duration
measure: Change from baseline in Young Mania Rating Scale (YMRS)
timeFrame: Weeks 4, 8, and 12 of the treatment duration
Secondary outcomes:
measure: Clinical Global Impression (CGI)
timeFrame: Weeks 4, 8, and 12 of the treatment duration
measure: Morisky Medication Adherence Scale (MMAS)
timeFrame: Weeks 4, 8, and 12 of the treatment duration, as well as Months 6 and 12.
measure: Plasma Drug Concentration
timeFrame: Weeks 4, 8, and 12 of the treatment duration
measure: Personal and Social Performance Scale (PSP)
timeFrame: Weeks 4, 8, and 12 of the treatment duration, as well as Months 6 and 12.
measure: Safety
timeFrame: Weeks 4, 8, and 12 of the treatment duration
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Sixth Hostipal
state: Beijing
Study officials:
References: