Depression - Major Depressive DisorderNCT06729541
Development and Application of Precision Treatment Strategies for Common Mental Disorders
A study testing Multigenetic Pharmacogenomics-Guided Treatment (MPGT) in people with Depression - Major Depressive Disorder and Schizophrenia Disorders, run by Peking University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression - Major Depressive Disorder, Schizophrenia Disorders, Bipolar Disorder (BD)
- What is being tested?
- Multigenetic Pharmacogenomics-Guided Treatment (MPGT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 11 Nov 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University Sixth Hostipal
Beijing, Beijing Municipality, 100191
Weihua Yue, 010-82805307, dryue@bjmu.edu.cn
About this study
Official title: Development and Application of Precision Treatment Strategies for Patients with Depression, Bipolar Disorder, and Schizophrenia: a Multicenter Randomized Controlled Trial
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.
- Being tested
- Multigenetic Pharmacogenomics-Guided Treatment (MPGT)
- Medical subject headings
- Schizophrenia, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multigenetic Pharmacogenomics-Guided Treatment (MPGT)Other
In the guidance group, drug types and dosages were adjusted based on the results of Pharmacogenetic TESTING.
| Study group | Role | What they receive |
|---|---|---|
| Guided | Experimental | 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 Receives: Other: Multigenetic Pharmacogenomics-Guided Treatment (MPGT) |
| Unguided | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Positive and Negative Syndrome Scale (PANSS)
The outcome is assessed by the Positive and Negative Syndrome Scale (PANSS). The PANSS consists of 30 items, divided into three subscales: Positive Symptoms (7 items), Negative Symptoms (7 items), and General Psychopathology (16 items). Each item is rated on a 7-point scale from 1 (absent) to 7 (extreme), with higher scores indicating more severe symptoms. The total PANSS score ranges from 30 to 210, with higher scores reflecting greater symptom severity.
Measured: Weeks 4, 8, and 12 of the treatment duration
Change from baseline in Hamilton Depression Rating Scale (HAMD)
The outcome is assessed by 17-item Hamilton Depression Rating Scale (HAMD-17) Scale. Total HAMD scores range from 0 to 24, with higher scores indicating more severe depressive symptoms.
Measured: Weeks 4, 8, and 12 of the treatment duration
Change from baseline in Young Mania Rating Scale (YMRS)
The outcome is assessed by the Young Mania Rating Scale (YMRS). The YMRS consists of 11 items that assess the severity of manic symptoms, including mood, speech, motor activity, sexual interest, sleep, and other behaviors. Each item is rated on a scale from 0 to 4, with higher scores indicating greater severity of manic symptoms. The total YMRS score can range from 0 to 44, with higher scores reflecting more severe mania.
Measured: Weeks 4, 8, and 12 of the treatment duration
Secondary outcomes (5)
Clinical Global Impression (CGI)
The outcome is assessed by the Clinical Global Impression (CGI) scale. The CGI consists of two main components: the CGI-Severity (CGI-S) and the CGI-Improvement (CGI-I).
CGI-Severity (CGI-S): This component rates the severity of the patient's illness on a 7-point scale, ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).
CGI-Improvement (CGI-I): This component evaluates the patient's improvement over time, also on a 7-point scale, ranging from 1 (very much improved) to 7 (very much worse).
The CGI scale provides an overall clinical assessment of the patient's condition, considering both the severity of illness and the degree of improvement.
Measured: Weeks 4, 8, and 12 of the treatment duration
Morisky Medication Adherence Scale (MMAS)
The outcome is assessed by the Morisky Medication Adherence Scale (MMAS). The MMAS is a self-reported scale used to assess a patient's adherence to prescribed medication regimens. It consists of 8 items that evaluate factors such as forgetfulness, understanding of medication instructions, and attitude toward treatment. The items are answered with "yes" or "no" responses, with higher scores indicating better medication adherence.
The MMAS is categorized as follows:
High adherence: score of 8 Medium adherence: score of 6-7 Low adherence: score of 0-5
Measured: Weeks 4, 8, and 12 of the treatment duration, as well as Months 6 and 12.
Plasma Drug Concentration
The outcome is assessed by Plasma Drug Concentration. Blood drug levels of antidepressants, antipsychotics, and mood stabilizers are measured to determine whether the concentrations fall within the therapeutic range for each respective medication. Therapeutic drug monitoring ensures that plasma drug levels are within the safe and effective range, avoiding both sub-therapeutic and potentially toxic concentrations. The concentration of each drug is compared to the recommended therapeutic window to assess if the patient is receiving an optimal dose.
Measured: Weeks 4, 8, and 12 of the treatment duration
Personal and Social Performance Scale (PSP)
The outcome is assessed by the Personal and Social Performance Scale (PSP). The PSP is a clinician-rated scale designed to assess an individual's level of functioning in four key areas:
Socially useful activities (e.g., work, education, social relationships) Personal and social relationships (e.g., relationships with family, friends, and the community) Self-care (e.g., personal hygiene, ability to live independently) Disturbing and aggressive behavior (e.g., level of agitation or violence)
The PSP provides a global score ranging from 1 to 100, where lower scores indicate more severe dysfunction and higher scores indicate better social and personal performance. The total PSP score is classified as follows:
Score 91-100: Normal functioning Score 61-90: Mild functional impairment Score 31-60: Moderate functional impairment Score 1-30: Severe functional impairment
Measured: Weeks 4, 8, and 12 of the treatment duration, as well as Months 6 and 12.
Safety
Laboratory tests (including complete blood count, liver and kidney function, prolactin levels, and electrocardiogram) were conducted at baseline and at Weeks 4, 8, and 12 of the treatment duration. Safety was assessed using adverse event scales (e.g., TESS and SAS).
Measured: Weeks 4, 8, and 12 of the treatment duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2024
- Study start11 Nov 2024
- Primary completionJul 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression - Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weihua Yue, Peking University Sixth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06729541
- Sponsor's protocol ID
- 2024-23
- Status last verified
- Dec 2024
- First submitted
- 4 Dec 2024
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Application of Precision Treatment Strategies for Patients with Depression, Bipolar Disorder, and Schizophrenia: a Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06729541
- Acronym / sponsor ID
- 2024-23
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 11 Nov 2024 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 11 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Guided | Experimental | Other: Multigenetic Pharmacogenomics-Guided Treatment (MPGT)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 |
| Unguided | No intervention | –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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multigenetic Pharmacogenomics-Guided Treatment (MPGT)In the guidance group, drug types and dosages were adjusted based on the results of Pharmacogenetic TESTING. | Other | Guided |
Primary outcome
Change from baseline in Positive and Negative Syndrome Scale (PANSS)
Time frame: Weeks 4, 8, and 12 of the treatment duration
The outcome is assessed by the Positive and Negative Syndrome Scale (PANSS). The PANSS consists of 30 items, divided into three subscales: Positive Symptoms (7 items), Negative Symptoms (7 items), and General Psychopathology (16 items). Each item is rated on a 7-point scale from 1 (absent) to 7 (extreme), with higher scores indicating more severe symptoms. The total PANSS score ranges from 30 to 210, with higher scores reflecting greater symptom severity.
Change from baseline in Hamilton Depression Rating Scale (HAMD)
Time frame: Weeks 4, 8, and 12 of the treatment duration
The outcome is assessed by 17-item Hamilton Depression Rating Scale (HAMD-17) Scale. Total HAMD scores range from 0 to 24, with higher scores indicating more severe depressive symptoms.
Change from baseline in Young Mania Rating Scale (YMRS)
Time frame: Weeks 4, 8, and 12 of the treatment duration
The outcome is assessed by the Young Mania Rating Scale (YMRS). The YMRS consists of 11 items that assess the severity of manic symptoms, including mood, speech, motor activity, sexual interest, sleep, and other behaviors. Each item is rated on a scale from 0 to 4, with higher scores indicating greater severity of manic symptoms. The total YMRS score can range from 0 to 44, with higher scores reflecting more severe mania.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multigenetic Pharmacogenomics-Guided Treatment (MPGT) in people with Depression - Major Depressive Disorder and Schizophrenia Disorders, run by Peking University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Weihua Yue (86-010-82805307, dryue@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Positive and Negative Syndrome Scale (PANSS) (time frame: Weeks 4, 8, and 12 of the treatment duration). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2024; AzTrials last refreshed its copy on 7 Nov 2026.