Major Depressive Disorder (MDD)NCT07571226
Identification and Molecular Characterisation of Urban-environmental Stress Patterns Affecting Mental Illness
An observational study of Major Depressive Disorder (MDD) and Anxiety Disorder, run by Huashan Hospital at 3 sites in China.
Trial summary
Mental disorders have become a major contributor to the global burden of non-communicable diseases, with disability-adjusted life years (DALYs) attributable to these conditions continuing to rise. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder (MDD), Anxiety Disorder, Alcohol Use Disorder (AUD)
- What is being tested?
- wearable monitoring devices
- Type of treatment
- Medical device
- How many people
- 680 participants
- Where
- 3 sitesChina
- Study dates
- 10 Apr 2026to 30 May 2029
- Phase
- Observational
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Participants will be recruited from adult individuals aged 18-60 years, including patients diagnosed with depressive disorder, generalized anxiety disorder, or alcohol use disorder according to DSM-IV criteria, as well as healthy control subjects without mental disorders.
Who may be able to join
- Diagnosis: The primary diagnosis meets the DSM-IV criteria for depressive disorder, generalized anxiety disorder, or alcohol use disorder, and comorbid conditions may be present;
- Patients with mental disorders aged 18-60 years, with a balanced gender ratio;
- Normal intelligence and ability to use a smartphone running the Android operating system;
- Willingness to wear a wristband equipped with physiological monitoring functions (such as heart rate and electrodermal activity), download the study application, and upload data during the study period;
- Participants with depression or generalized anxiety disorder who are taking medication must be on a single stable dose of a selective serotonin reuptake inhibitor (SSRI), specifically citalopram or escitalopram, and this medication regimen must have been maintained for at least 5 days. Participants with alcohol use disorder who are taking medication have no restriction on the type of drug, but the medication regimen should also have been maintained for at least 5 days. At baseline assessment, patients with depression or anxiety disorders should have a Hamilton Depression Rating Scale (HAMD-17) score >7 or a Hamilton Anxiety Rating Scale (HAMA-14) score >7.;
- Voluntary participation in this study and signing of informed consent;
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- For patients with alcohol use disorder (AUD): AUD patients must have successfully completed alcohol withdrawal, confirmed by clinical standards or relevant healthcare professionals.
- Healthy subjects aged 18-60 years, with a balanced gender ratio;
- Normal intelligence and ability to use a smartphone running the Android operating system;
- Willingness to wear a wristband equipped with physiological monitoring functions (such as heart rate and electrodermal activity), download the study application, and upload data during the study period;
- Voluntary participation in this study and signing of informed consent.
Who cannot join
- Currently taking opioid medications;
- Receiving any form of brain stimulation therapy within the past 1 month (including transcranial magnetic stimulation (TMS), electroconvulsive therapy (ECT), or other similar treatments);
- Skin infection or severe skin damage on the wrist or upper limbs that may affect the normal use of monitoring devices;
- Recent use (within 30 days) of medications that may interfere with drug metabolism, such as strong CYP450 inhibitors/inducers;
- Severe physical diseases (such as brain tumors or injuries) or special conditions (such as current pregnancy or lactation) that may affect the study protocol;
- HAMD-17 item 3 (suicide) >3 points (severe suicidal behavior);
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- Currently using benzodiazepines or opioid medications;
- Currently receiving any form of brain stimulation therapy (including transcranial magnetic stimulation (TMS), electroconvulsive therapy (ECT), or other similar treatments);
- Skin infection or severe skin damage on the wrist or upper limbs that may affect the normal use of monitoring devices;
- Recent use (within 30 days) of medications that may interfere with drug metabolism, such as strong CYP450 inhibitors/inducers, or not reaching steady-state drug concentration before the study;
- Severe physical diseases (such as brain tumors or injuries) or special conditions (such as current pregnancy or lactation) that may affect the study protocol.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
Peking University Sixth Hospital
Beijing
- Recruiting
Huashan Hospital Affiliated to Fudan University
Shanghai
Yanqun Zheng, 13651748730
- Recruiting
Shanghai Mental Health Center
Shanghai
About this study
Mental disorders have become a major contributor to the global burden of non-communicable diseases, with disability-adjusted life years (DALYs) attributable to these conditions continuing to rise. Although evidence suggests that environmental factors may account for up to 40% of the attributable risk for mental disorders such as major depressive disorder, anxiety disorders, and alcohol use disorder, the underlying mechanisms remain unclear, particularly regarding how dynamic environmental stress influences disease onset, progression, and relapse. Traditional research has primarily focused on individual-level psychosocial factors, including socioeconomic status and life events, while lacking real-time, multidimensional assessments of objective urban environmental stressors such as air pollution, noise exposure, and reduced green space.
This study proposes a prospective longitudinal cohort design based in real-world environments, enrolling both patients with mental disorders and healthy controls. Using wearable devices integrated with the "'StreetMind'" mobile application and wear the visible watch, we will continuously and dynamically collect multimodal data on environmental exposures and physiological responses in urban settings. These include photoplethysmography (PPG)-derived heart rate, oxygen saturation, physical activity, and gait parameters, as well as objective environmental indicators such as temperature, humidity, light intensity, and noise levels. At baseline, all participants will undergo standardized psychiatric assessments to characterize depressive, anxiety, and addictive conditions. Peripheral blood and urine samples will also be collected for subsequent molecular and multi-omics analyses.
The study aims to systematically evaluate the associations between urban environmental factors-including air pollution, noise exposure, and green space availability-and the risk of mental disorder relapse. Furthermore, it seeks to elucidate the potential mechanisms by which environmental stress affects mental health through neuroinflammation and alterations in brain circuitry. The findings are expected to provide novel insights for risk prediction, early intervention, and precision management of mental disorders.
- Being tested
- wearable monitoring devices
- Medical subject headings
- Depressive Disorder, Major, Anxiety Disorders, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
wearable monitoring devicesDevice
This study uses a wrist-worn smartwatch to enable continuous, real-time monitoring of physiological parameters, including heart rate, oxygen saturation, and physical activity.
| Study group | Role | What they receive |
|---|---|---|
| Major depressive disorder (MDD） | Not described Receives: Device: wearable monitoring devices | |
| Anxiety disorder (ANX) | Not described Receives: Device: wearable monitoring devices | |
| Alcohol use disorde (AUD) | Not described Receives: Device: wearable monitoring devices | |
| Healthy individuals (CON) | Not described Receives: Device: wearable monitoring devices |
What is being measured
The primary outcome is the main question the study is designed to answer.
To characterize fine-grained features of urban environmental stress and evaluate their predictive validity for the development and progression of mental disorders
Measured: 4 weeks (participants will wear the device continuously during the study period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start10 Apr 2026
- Primary completion1 Apr 2029 (estimated)
- Study completion30 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive Disorder (MDD)Studies of the same condition, open and under way.
- More trials run by Huashan HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 680 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chongbo Zhao, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07571226
- Sponsor's protocol ID
- KY2025-1492
- Status last verified
- May 2026
- First submitted
- 29 Apr 2026
- Last updated
- 3 Jun 2026
- Results posted
- 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 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification and Molecular Characterisation of Urban-environmental Stress Patterns Affecting Mental Illness
- ClinicalTrials.gov ID
- NCT07571226
- Acronym / sponsor ID
- KY2025-1492
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 680 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Study start
- 10 Apr 2026 (actual)
- Primary completion
- 1 Apr 2029 (estimated)
- Study completion
- 30 May 2029 (estimated)
- First posted
- 6 May 2026 (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.
Mental disorders have become a major contributor to the global burden of non-communicable diseases, with disability-adjusted life years (DALYs) attributable to these conditions continuing to rise. Although evidence suggests that environmental factors may account for up to 40% of the attributable risk for mental disorders such as major depressive disorder, anxiety disorders, and alcohol use disorder, the underlying mechanisms remain unclear, particularly regarding how dynamic environmental stress influences disease onset, progression, and relapse. Traditional research has primarily focused on individual-level psychosocial factors, including socioeconomic status and life events, while lacking real-time, multidimensional assessments of objective urban environmental stressors such as air pollution, noise exposure, and reduced green space.
This study proposes a prospective longitudinal cohort design based in real-world environments, enrolling both patients with mental disorders and healthy controls. Using wearable devices integrated with the "'StreetMind'" mobile application and wear the visible watch, we will continuously and dynamically collect multimodal data on environmental exposures and physiological responses in urban settings. These include photoplethysmography (PPG)-derived heart rate, oxygen saturation, physical activity, and gait parameters, as well as objective environmental indicators such as temperature, humidity, light intensity, and noise levels. At baseline, all participants will undergo standardized psychiatric assessments to characterize depressive, anxiety, and addictive conditions. Peripheral blood and urine samples will also be collected for subsequent molecular and multi-omics analyses.
The study aims to systematically evaluate the associations between urban environmental factors-including air pollution, noise exposure, and green space availability-and the risk of mental disorder relapse. Furthermore, it seeks to elucidate the potential mechanisms by which environmental stress affects mental health through neuroinflammation and alterations in brain circuitry. The findings are expected to provide novel insights for risk prediction, early intervention, and precision management of mental disorders.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Major depressive disorder (MDD） | – | Device: wearable monitoring devices |
| Anxiety disorder (ANX) | – | Device: wearable monitoring devices |
| Alcohol use disorde (AUD) | – | Device: wearable monitoring devices |
| Healthy individuals (CON) | – | Device: wearable monitoring devices |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Participants will be recruited from adult individuals aged 18-60 years, including patients diagnosed with depressive disorder, generalized anxiety disorder, or alcohol use disorder according to DSM-IV criteria, as well as healthy control subjects without mental disorders.
Key inclusion criteria (11 listed)
- Diagnosis: The primary diagnosis meets the DSM-IV criteria for depressive disorder, generalized anxiety disorder, or alcohol use disorder, and comorbid conditions may be present;
- Patients with mental disorders aged 18-60 years, with a balanced gender ratio;
- Normal intelligence and ability to use a smartphone running the Android operating system;
- Willingness to wear a wristband equipped with physiological monitoring functions (such as heart rate and electrodermal activity), download the study application, and upload data during the study period;
- Participants with depression or generalized anxiety disorder who are taking medication must be on a single stable dose of a selective serotonin reuptake inhibitor (SSRI), specifically citalopram or escitalopram, and this medication regimen must have been maintained for at least 5 days. Participants with alcohol use disorder who are taking medication have no restriction on the type of drug, but the medication regimen should also have been maintained for at least 5 days. At baseline assessment, patients with depression or anxiety disorders should have a Hamilton Depression Rating Scale (HAMD-17) score >7 or a Hamilton Anxiety Rating Scale (HAMA-14) score >7.;
Key exclusion criteria (11 listed)
- Currently taking opioid medications;
- Receiving any form of brain stimulation therapy within the past 1 month (including transcranial magnetic stimulation (TMS), electroconvulsive therapy (ECT), or other similar treatments);
- Skin infection or severe skin damage on the wrist or upper limbs that may affect the normal use of monitoring devices;
- Recent use (within 30 days) of medications that may interfere with drug metabolism, such as strong CYP450 inhibitors/inducers;
- Severe physical diseases (such as brain tumors or injuries) or special conditions (such as current pregnancy or lactation) that may affect the study protocol;
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 |
|---|---|---|
| wearable monitoring devicesThis study uses a wrist-worn smartwatch to enable continuous, real-time monitoring of physiological parameters, including heart rate, oxygen saturation, and physical activity. | Device | Alcohol use disorde (AUD), Anxiety disorder (ANX), Healthy individuals (CON), Major depressive disorder (MDD） |
Primary outcome
To characterize fine-grained features of urban environmental stress and evaluate their predictive validity for the development and progression of mental disorders
Time frame: 4 weeks (participants will wear the device continuously during the study period)
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 3 Jun 2026.
- 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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Depressive Disorder (MDD) and Anxiety Disorder, run by Huashan Hospital at 3 sites 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 11 inclusion and 11 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 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 Yanqun Zheng Dr (+8613651748730, zhengyanqun@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To characterize fine-grained features of urban environmental stress and evaluate their predictive validity for the development and progression of mental disorders (time frame: 4 weeks (participants will wear the device continuously during the study period)). 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 3 Jun 2026.