Anxiety DisordersNCT07903246
A Prospective Study of Anxiety, Depression, and Bipolar Disorder in People
An observational study of Anxiety Disorders and Depressive Disorder, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
This study aims to understand how anxiety disorders, depressive disorders, and bipolar disorder change over time and to identify patterns that may help with earlier recognition, diagnosis, and prediction of future symptoms. Read more about this study
- Who is it for?
- Ages 12 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety Disorders, Depressive Disorder, Bipolar Disorder (BD)
- How many people
- 2,690 participants
- Where
- 1 siteChina
- Study dates
- 15 Sep 2026to 31 Dec 2030
- 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 12 to 55 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Participants aged 12-55 years will be recruited across participating hospitals in Zhejiang Province, China, through outpatient referrals and public recruitment announcements, including WeChat public-account posts. The study population comprises individuals with DSM-5 anxiety disorders, depressive disorders, or bipolar I or II disorder, and healthy volunteers meeting the control-group eligibility criteria. Enrollment will occur on a rolling basis. The planned sample includes 1,590 participants in the model development cohort and 1,100 participants in a separate independent validation cohort. Each participant will be followed for 36 months after baseline.
Who may be able to join
- General criteria for all groups:
- Age 12 to 55 years, inclusive, of any sex.
- Education at or above the third-grade primary school level.
- Voluntary participation with written informed consent. For participants younger than 18 years, written informed consent from a legal guardian and the participant's assent, when capable, are required. For participants with impaired consent capacity, consent will be obtained from the participant and/or legal guardian as specified in the protocol.
- Anxiety disorders group:
- Meet DSM-5 diagnostic criteria for one or more anxiety spectrum disorders.
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- Hamilton Anxiety Rating Scale (HAMA-14) total score of at least 14.
- Normal intellectual functioning, vision, and hearing.
- Depressive disorders group:
- Meet DSM-5 diagnostic criteria for one or more depressive disorders.
- Hamilton Depression Rating Scale (HAMD-17) total score of at least 17.
- Normal intellectual functioning, vision, and hearing.
- Bipolar disorder group:
- Meet DSM-5 diagnostic criteria for bipolar I or bipolar II disorder.
- Not currently experiencing a manic episode.
- Normal intellectual functioning, vision, and hearing.
- Healthy control group:
- Normal or corrected-to-normal vision.
- Good physical health, without serious physical illness or chronic disease.
- Normal cognitive functioning.
- No family history of mental illness across three generations on either the maternal or paternal side.
Who cannot join
- The following criteria apply to all groups:
- Failure to meet the inclusion criteria for the relevant group, or meeting DSM-5 criteria for a mental disorder other than those targeted by this study.
- Current risk of dangerous behavior, rated as level 2 or above on the dangerousness assessment specified in the protocol.
- Severe agitation, oppositional behavior, or markedly reduced volition or activity that prevents completion of the assessments.
- Current or previous organic brain disease, a history of epilepsy, or a history of traumatic brain injury.
- A history of drug or substance abuse, including tobacco, alcohol, or other psychoactive substances.
Show all 13Show fewer
- Cardiovascular, cerebrovascular, respiratory, or neurological disease; infectious disease; other serious physical illness; or a pathological condition that may cause cognitive impairment.
- Limb disability or inability to make the required button-press responses using the upper limbs.
- Pregnancy or breastfeeding.
- Electroconvulsive therapy, transcranial magnetic stimulation, alternating-current or direct-current electrical stimulation, vagus nerve stimulation, or deep brain stimulation within the previous 6 months.
- Metal implants or other metallic objects that cannot be safely removed and prevent safe magnetic resonance imaging.
- Red-green color blindness.
- Any other condition that, in the investigator's judgment, makes participation unsuitable.
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
The Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 313000
Human Subject Research Ethics Committee, +86057187783759, keyanlunli_zheer@163.com
About this study
Official title: A Prospective Cohort Study of Emotion-Related Disorders
This study aims to understand how anxiety disorders, depressive disorders, and bipolar disorder change over time and to identify patterns that may help with earlier recognition, diagnosis, and prediction of future symptoms.
The study will enroll approximately 2,690 participants aged 12 to 55 years across multiple hospitals in China. Participants will include people with anxiety disorders, depressive disorders, or bipolar disorder, as well as healthy volunteers for comparison.
Read more
Participants will be followed for 3 years after enrollment, with assessments at baseline and at 1, 6, 12, 18, 24, 30, and 36 months. Study assessments will collect information about symptoms, treatment, daily functioning, and quality of life. Other study data will include biological samples, brain imaging, recordings of brain electrical activity, and measurements from wearable devices and tasks involving speech, facial expressions, and eye movements.
Researchers will examine how these measurements relate to symptoms and changes in health over time. They will also develop and evaluate artificial intelligence models intended to help identify these disorders and predict treatment outcomes, relapse, and suicide or self-harm risk.
This is an observational study. The researchers will not assign treatments or change participants' treatment as part of the study. Treatments received during routine clinical care will be recorded.
Read the detailed description
This multicenter prospective cohort study will establish a standardized research database integrating clinical assessments, biological samples, neuroimaging, electroencephalography, and digital measurements in participants with anxiety disorders, depressive disorders, bipolar disorder, and healthy controls.
Enrollment will occur on a rolling basis, and follow-up visits will be scheduled relative to each participant's baseline assessment. Each participant will be followed for 36 months unless they withdraw or otherwise discontinue participation.
The study comprises two stages. The model development cohort will include 1,590 participants: 380 with anxiety disorders, 380 with depressive disorders, 380 with bipolar disorder, and 450 healthy controls. A separate independent validation cohort will include 1,100 participants, with 275 in each of the four groups. This second cohort will be used to evaluate model discrimination, sensitivity, specificity, calibration, and generalizability across centers.
The research database will integrate clinical and psychosocial information with biological samples for multi-omics analyses, structural and functional magnetic resonance imaging, diffusion tensor imaging, 64-channel electroencephalography, and digital measurements from wearable devices, speech, facial expressions, and eye movements. Standardized data collection procedures and longitudinal tracking will support comparisons across groups, centers, and assessment time points.
Analyses will investigate associations between these measurements and clinical characteristics, symptom trajectories, treatment outcomes, relapse, and suicide or self-harm risk. Longitudinal analyses will also explore how biological changes interact with environmental and psychosocial factors. Statistical approaches will include multivariable analyses, mixed-effects models, survival analyses, structural equation modeling, and machine learning, as appropriate to the research question.
The study will develop and independently validate multimodal artificial intelligence models for early recognition and diagnostic support, and explore models for predicting treatment outcomes, relapse, and suicide or self-harm risk. Model development and evaluation are research activities within this observational cohort; no treatment is assigned by the study protocol.
- Keywords
- Prospective Cohort Study, Digital Phenotyping, Multimodal Data, Artificial Intelligence, Multi-Omics, Neuroimaging, Electroencephalography, Wearable Devices
- Medical subject headings
- Anxiety Disorders, Depressive Disorder, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Anxiety Disorders | Participants aged 12-55 years who meet DSM-5 criteria for one or more anxiety disorders and have a Hamilton Anxiety Rating Scale (HAMA-14) total score of at least 14. Planned enrollment is 655 participants: 380 in the model development cohort and 275 in the independent validation cohort. Participants will undergo baseline assessments and follow-up at 1, 6, 12, 18, 24, 30, and 36 months. No treatment is assigned by the study; routine clinical care and treatment received will be recorded. | |
| Depressive Disorders | Participants aged 12-55 years who meet DSM-5 criteria for a depressive disorder and have a 17-item Hamilton Depression Rating Scale (HAMD-17) total score of at least 17. This group includes participants with and without a history of suicide attempts or self-harm. Planned enrollment is 655 participants: 380 in the model development cohort and 275 in the independent validation cohort. Participants will undergo baseline assessments and follow-up at 1, 6, 12, 18, 24, 30, and 36 months. No treatment is assigned by the study; routine clinical care and treatment received will be recorded. | |
| Bipolar Disorder | Participants aged 12-55 years who meet DSM-5 criteria for bipolar I or bipolar II disorder and are not experiencing a manic episode at enrollment. Planned enrollment is 655 participants: 380 in the model development cohort and 275 in the independent validation cohort. Participants will undergo baseline assessments and follow-up at 1, 6, 12, 18, 24, 30, and 36 months. No treatment is assigned by the study; routine clinical care and treatment received will be recorded. | |
| Healthy Controls | Healthy participants aged 12-55 years who meet the protocol-defined eligibility criteria for the control group, including normal cognitive functioning, no serious physical or chronic disease, and no family history of mental illness across three generations on either the maternal or paternal side. Planned enrollment is 725 participants: 450 in the model development cohort and 275 in the independent validation cohort. Participants will undergo baseline assessments and follow-up at 1, 6, 12, 18, 24, 30, and 36 months. No treatment is assigned by the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Macro-Averaged Area Under the ROC Curve of the Multimodal Digital Phenotyping-Based Diagnostic Model in the Independent Validation Cohort
The model will use multimodal digital phenotyping data to identify three diagnostic labels: depressive disorders, anxiety disorders, and bipolar disorder. Reference diagnoses will be established by psychiatrists using MINI interviews and clinical diagnostic assessment. Co-occurring diagnoses will be represented according to diagnostic criteria, allowing anxiety disorders to coexist with depressive or bipolar disorders. An area under the receiver operating characteristic curve (AUC) will be calculated separately for each label. The primary measure will be the unweighted mean of the three label-specific AUCs. Healthy controls will be negative for all three labels. AUC ranges from 0 to 1, with higher values indicating better discrimination. A 95% confidence interval will be calculated using bootstrap resampling. Feature selection, tuning, and training will be completed in the development cohort, and the model will be locked before independent validation.
Measured: Baseline (at enrollment in the independent validation cohort).
Change From Baseline in 17-Item Hamilton Depression Rating Scale (HAMD-17) Score
Depressive symptom severity will be assessed using the 17-item Hamilton Depression Rating Scale (HAMD-17). Total scores range from 0 to 52, with higher scores indicating more severe depressive symptoms. The outcome is the change in total score at each follow-up assessment relative to baseline, calculated as the follow-up score minus the baseline score. Results will be analyzed separately for the depressive disorders group and the bipolar disorder group. Negative changes indicate improvement.
Measured: Baseline and 1, 6, 12, 18, 24, 30, and 36 months after baseline.
Change From Baseline in 14-Item Hamilton Anxiety Rating Scale (HAMA-14) Score
Anxiety symptom severity will be assessed using the 14-item Hamilton Anxiety Rating Scale (HAMA-14). Each item is scored from 0 to 4, yielding a total score from 0 to 56. Higher scores indicate more severe anxiety symptoms. The outcome is the change in total score at each follow-up assessment relative to baseline, calculated as the follow-up score minus the baseline score. Negative changes indicate improvement.
Measured: Baseline and 1, 6, 12, 18, 24, 30, and 36 months after baseline.
Change From Baseline in Bech-Rafaelsen Mania Rating Scale (BRMS) Score in the Bipolar Disorder Group
Manic symptom severity in participants with bipolar disorder will be assessed using the 11-item Bech-Rafaelsen Mania Rating Scale (BRMS). Each item is scored from 0 to 4, yielding a total score from 0 to 44. Higher scores indicate more severe manic symptoms. The outcome is the change in total score at each follow-up assessment relative to baseline, calculated as the follow-up score minus the baseline score. Negative changes indicate improvement.
Measured: Baseline and 1, 6, 12, 18, 24, 30, and 36 months after baseline.
Secondary outcomes (8)
Sensitivity of the Diagnostic Model in the Independent Validation Cohort
Sensitivity will be calculated separately for the depressive disorder, anxiety disorder, and bipolar disorder labels, with reference diagnoses established by psychiatrists using MINI interviews and clinical diagnostic assessment. Each label will be evaluated as a separate binary outcome, allowing co-occurring diagnoses according to diagnostic criteria. Sensitivity is the number of true positives divided by the sum of true positives and false negatives. Values range from 0 to 1, with higher values indicating better sensitivity. Each estimate will be reported with a 95% confidence interval. The model and label-specific classification thresholds will be fixed using the development cohort before independent validation and will not be adjusted using validation data.
Measured: Baseline (at enrollment in the independent validation cohort).
Specificity of the Diagnostic Model in the Independent Validation Cohort
Specificity will be calculated separately for the depressive disorder, anxiety disorder, and bipolar disorder labels, with reference diagnoses established by psychiatrists using MINI interviews and clinical diagnostic assessment. Each label will be evaluated as a separate binary outcome, allowing co-occurring diagnoses according to diagnostic criteria. Specificity is the number of true negatives divided by the sum of true negatives and false positives. Values range from 0 to 1, with higher values indicating better specificity. Each estimate will be reported with a 95% confidence interval. The model and label-specific classification thresholds will be fixed using the development cohort before independent validation and will not be adjusted using validation data.
Measured: Baseline (at enrollment in the independent validation cohort).
Label-Specific Accuracy of the Diagnostic Model in the Independent Validation Cohort
Accuracy will be calculated separately for the depressive disorder, anxiety disorder, and bipolar disorder labels, with reference diagnoses established by psychiatrists using MINI interviews and clinical diagnostic assessment. Each label will be evaluated as a separate binary outcome, allowing co-occurring diagnoses according to diagnostic criteria. Label-specific accuracy is the sum of true positives and true negatives divided by the number of participants evaluated for that label. Values range from 0 to 1, with higher values indicating better accuracy. Each estimate will be reported with a 95% confidence interval. The model and label-specific classification thresholds will be fixed using the development cohort before independent validation and will not be adjusted using validation data.
Measured: Baseline (at enrollment in the independent validation cohort).
Positive Predictive Value of the Diagnostic Model in the Independent Validation Cohort
Positive predictive value will be calculated separately for the depressive disorder, anxiety disorder, and bipolar disorder labels, with reference diagnoses established by psychiatrists using MINI interviews and clinical diagnostic assessment. Each label will be evaluated as a separate binary outcome, allowing co-occurring diagnoses according to diagnostic criteria. Positive predictive value is the number of true positives divided by the sum of true positives and false positives. Values range from 0 to 1, with higher values indicating better positive predictive value. Each estimate will be reported with a 95% confidence interval. The model and label-specific classification thresholds will be fixed using the development cohort before independent validation and will not be adjusted using validation data.
Measured: Baseline (at enrollment in the independent validation cohort).
Negative Predictive Value of the Diagnostic Model in the Independent Validation Cohort
Negative predictive value will be calculated separately for the depressive disorder, anxiety disorder, and bipolar disorder labels, with reference diagnoses established by psychiatrists using MINI interviews and clinical diagnostic assessment. Each label will be evaluated as a separate binary outcome, allowing co-occurring diagnoses according to diagnostic criteria. Negative predictive value is the number of true negatives divided by the sum of true negatives and false negatives. Values range from 0 to 1, with higher values indicating better negative predictive value. Each estimate will be reported with a 95% confidence interval. The model and label-specific classification thresholds will be fixed using the development cohort before independent validation and will not be adjusted using validation data.
Measured: Baseline (at enrollment in the independent validation cohort).
Change From Baseline in Patient Health Questionnaire-9 (PHQ-9) Score
Depressive symptom severity will be assessed using the 9-item Patient Health Questionnaire (PHQ-9). Total scores range from 0 to 27, with higher scores indicating more severe depressive symptoms. The outcome is the change in total score at each follow-up assessment relative to baseline, calculated as the follow-up score minus the baseline score. Negative changes indicate improvement.
Measured: Baseline and 1, 6, 12, 18, 24, 30, and 36 months after baseline.
Change From Baseline in Generalized Anxiety Disorder-7 (GAD-7) Score
Anxiety symptom severity will be assessed using the 7-item Generalized Anxiety Disorder scale (GAD-7). Total scores range from 0 to 21, with higher scores indicating more severe anxiety symptoms. The outcome is the change in total score at each follow-up assessment relative to baseline, calculated as the follow-up score minus the baseline score. Negative changes indicate improvement.
Measured: Baseline and 1, 6, 12, 18, 24, 30, and 36 months after baseline.
Mean Absolute Error of Baseline HAMD-17 Score Estimation in the Independent Validation Cohort
The model will use baseline multimodal digital phenotyping data to estimate the concurrently assessed 17-item Hamilton Depression Rating Scale (HAMD-17) total score. Performance will be evaluated in the independent validation cohort using clinician-rated HAMD-17 scores as the reference. Mean absolute error (MAE) will be calculated as the mean absolute difference between model-estimated and observed HAMD-17 total scores, expressed in HAMD-17 score points. Lower values indicate better estimation accuracy. Model development, feature selection, and parameter tuning will be completed in the development cohort, and the model will be locked before independent validation.
Measured: Baseline (at enrollment in the independent validation cohort).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study start15 Sep 2026
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- 2,690 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- The Affiliated Kangning Hospital of Ningbo University, Huzhou Third People's Hospital, the Seventh Hospital of Shaoxing City, Zhejiang Provincial Tongde Hospital, Xiaoshan People's Hospital, First Affiliated Hospital of Zhejiang University, Lishui Second People's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07903246
- Sponsor's protocol ID
- 2025-0296
- Other IDs
- 2026C01012
- Status last verified
- Sep 2026
- First submitted
- 7 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Study of Emotion-Related Disorders
- ClinicalTrials.gov ID
- NCT07903246
- Acronym / sponsor ID
- 2025-0296
- Keywords
- Prospective Cohort Study, Digital Phenotyping, Multimodal Data, Artificial Intelligence, Multi-Omics, Neuroimaging, Electroencephalography, Wearable Devices
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,690 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- The Affiliated Kangning Hospital of Ningbo University, Huzhou Third People's Hospital, the Seventh Hospital of Shaoxing City, Zhejiang Provincial Tongde Hospital, Xiaoshan People's Hospital, First Affiliated Hospital of Zhejiang University, Lishui Second People's Hospital
- Study start
- 15 Sep 2026 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 29 Oct 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.
This study aims to understand how anxiety disorders, depressive disorders, and bipolar disorder change over time and to identify patterns that may help with earlier recognition, diagnosis, and prediction of future symptoms.
The study will enroll approximately 2,690 participants aged 12 to 55 years across multiple hospitals in China. Participants will include people with anxiety disorders, depressive disorders, or bipolar disorder, as well as healthy volunteers for comparison.
Participants will be followed for 3 years after enrollment, with assessments at baseline and at 1, 6, 12, 18, 24, 30, and 36 months. Study assessments will collect information about symptoms, treatment, daily functioning, and quality of life. Other study data will include biological samples, brain imaging, recordings of brain electrical activity, and measurements from wearable devices and tasks involving speech, facial expressions, and eye movements.
Researchers will examine how these measurements relate to symptoms and changes in health over time. They will also develop and evaluate artificial intelligence models intended to help identify these disorders and predict treatment outcomes, relapse, and suicide or self-harm risk.
This is an observational study. The researchers will not assign treatments or change participants' treatment as part of the study. Treatments received during routine clinical care will be recorded.
Detailed description
This multicenter prospective cohort study will establish a standardized research database integrating clinical assessments, biological samples, neuroimaging, electroencephalography, and digital measurements in participants with anxiety disorders, depressive disorders, bipolar disorder, and healthy controls.
Enrollment will occur on a rolling basis, and follow-up visits will be scheduled relative to each participant's baseline assessment. Each participant will be followed for 36 months unless they withdraw or otherwise discontinue participation.
The study comprises two stages. The model development cohort will include 1,590 participants: 380 with anxiety disorders, 380 with depressive disorders, 380 with bipolar disorder, and 450 healthy controls. A separate independent validation cohort will include 1,100 participants, with 275 in each of the four groups. This second cohort will be used to evaluate model discrimination, sensitivity, specificity, calibration, and generalizability across centers.
The research database will integrate clinical and psychosocial information with biological samples for multi-omics analyses, structural and functional magnetic resonance imaging, diffusion tensor imaging, 64-channel electroencephalography, and digital measurements from wearable devices, speech, facial expressions, and eye movements. Standardized data collection procedures and longitudinal tracking will support comparisons across groups, centers, and assessment time points.
Analyses will investigate associations between these measurements and clinical characteristics, symptom trajectories, treatment outcomes, relapse, and suicide or self-harm risk. Longitudinal analyses will also explore how biological changes interact with environmental and psychosocial factors. Statistical approaches will include multivariable analyses, mixed-effects models, survival analyses, structural equation modeling, and machine learning, as appropriate to the research question.
The study will develop and independently validate multimodal artificial intelligence models for early recognition and diagnostic support, and explore models for predicting treatment outcomes, relapse, and suicide or self-harm risk. Model development and evaluation are research activities within this observational cohort; no treatment is assigned by the study protocol.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Anxiety Disorders | – | –Participants aged 12-55 years who meet DSM-5 criteria for one or more anxiety disorders and have a Hamilton Anxiety Rating Scale (HAMA-14) total score of at least 14. Planned enrollment is 655 participants: 380 in the model development cohort and 275 in the independent validation cohort. Participants will undergo baseline assessments and follow-up at 1, 6, 12, 18, 24, 30, and 36 months. No treatment is assigned by the study; routine clinical care and treatment received will be recorded. |
| Depressive Disorders | – | –Participants aged 12-55 years who meet DSM-5 criteria for a depressive disorder and have a 17-item Hamilton Depression Rating Scale (HAMD-17) total score of at least 17. This group includes participants with and without a history of suicide attempts or self-harm. Planned enrollment is 655 participants: 380 in the model development cohort and 275 in the independent validation cohort. Participants will undergo baseline assessments and follow-up at 1, 6, 12, 18, 24, 30, and 36 months. No treatment is assigned by the study; routine clinical care and treatment received will be recorded. |
| Bipolar Disorder | – | –Participants aged 12-55 years who meet DSM-5 criteria for bipolar I or bipolar II disorder and are not experiencing a manic episode at enrollment. Planned enrollment is 655 participants: 380 in the model development cohort and 275 in the independent validation cohort. Participants will undergo baseline assessments and follow-up at 1, 6, 12, 18, 24, 30, and 36 months. No treatment is assigned by the study; routine clinical care and treatment received will be recorded. |
| Healthy Controls | – | –Healthy participants aged 12-55 years who meet the protocol-defined eligibility criteria for the control group, including normal cognitive functioning, no serious physical or chronic disease, and no family history of mental illness across three generations on either the maternal or paternal side. Planned enrollment is 725 participants: 450 in the model development cohort and 275 in the independent validation cohort. Participants will undergo baseline assessments and follow-up at 1, 6, 12, 18, 24, 30, and 36 months. No treatment is assigned by the study. |
Who may qualify
- Ages
- 12 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Participants aged 12-55 years will be recruited across participating hospitals in Zhejiang Province, China, through outpatient referrals and public recruitment announcements, including WeChat public-account posts. The study population comprises individuals with DSM-5 anxiety disorders, depressive disorders, or bipolar I or II disorder, and healthy volunteers meeting the control-group eligibility criteria. Enrollment will occur on a rolling basis. The planned sample includes 1,590 participants in the model development cohort and 1,100 participants in a separate independent validation cohort. Each participant will be followed for 36 months after baseline.
Key inclusion criteria (21 listed)
- Age 12 to 55 years, inclusive, of any sex.
- Education at or above the third-grade primary school level.
- Voluntary participation with written informed consent. For participants younger than 18 years, written informed consent from a legal guardian and the participant's assent, when capable, are required. For participants with impaired consent capacity, consent will be obtained from the participant and/or legal guardian as specified in the protocol.
- Meet DSM-5 diagnostic criteria for one or more anxiety spectrum disorders.
- Hamilton Anxiety Rating Scale (HAMA-14) total score of at least 14.
Key exclusion criteria (13 listed)
- The following criteria apply to all groups:
- Failure to meet the inclusion criteria for the relevant group, or meeting DSM-5 criteria for a mental disorder other than those targeted by this study.
- Current risk of dangerous behavior, rated as level 2 or above on the dangerousness assessment specified in the protocol.
- Severe agitation, oppositional behavior, or markedly reduced volition or activity that prevents completion of the assessments.
- Current or previous organic brain disease, a history of epilepsy, or a history of traumatic brain injury.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Macro-Averaged Area Under the ROC Curve of the Multimodal Digital Phenotyping-Based Diagnostic Model in the Independent Validation Cohort
Time frame: Baseline (at enrollment in the independent validation cohort).
The model will use multimodal digital phenotyping data to identify three diagnostic labels: depressive disorders, anxiety disorders, and bipolar disorder. Reference diagnoses will be established by psychiatrists using MINI interviews and clinical diagnostic assessment. Co-occurring diagnoses will be represented according to diagnostic criteria, allowing anxiety disorders to coexist with depressive or bipolar disorders. An area under the receiver operating characteristic curve (AUC) will be calculated separately for each label. The primary measure will be the unweighted mean of the three label-specific AUCs. Healthy controls will be negative for all three labels. AUC ranges from 0 to 1, with higher values indicating better discrimination. A 95% confidence interval will be calculated using bootstrap resampling. Feature selection, tuning, and training will be completed in the development cohort, and the model will be locked before independent validation.
Change From Baseline in 17-Item Hamilton Depression Rating Scale (HAMD-17) Score
Time frame: Baseline and 1, 6, 12, 18, 24, 30, and 36 months after baseline.
Depressive symptom severity will be assessed using the 17-item Hamilton Depression Rating Scale (HAMD-17). Total scores range from 0 to 52, with higher scores indicating more severe depressive symptoms. The outcome is the change in total score at each follow-up assessment relative to baseline, calculated as the follow-up score minus the baseline score. Results will be analyzed separately for the depressive disorders group and the bipolar disorder group. Negative changes indicate improvement.
Change From Baseline in 14-Item Hamilton Anxiety Rating Scale (HAMA-14) Score
Time frame: Baseline and 1, 6, 12, 18, 24, 30, and 36 months after baseline.
Anxiety symptom severity will be assessed using the 14-item Hamilton Anxiety Rating Scale (HAMA-14). Each item is scored from 0 to 4, yielding a total score from 0 to 56. Higher scores indicate more severe anxiety symptoms. The outcome is the change in total score at each follow-up assessment relative to baseline, calculated as the follow-up score minus the baseline score. Negative changes indicate improvement.
Change From Baseline in Bech-Rafaelsen Mania Rating Scale (BRMS) Score in the Bipolar Disorder Group
Time frame: Baseline and 1, 6, 12, 18, 24, 30, and 36 months after baseline.
Manic symptom severity in participants with bipolar disorder will be assessed using the 11-item Bech-Rafaelsen Mania Rating Scale (BRMS). Each item is scored from 0 to 4, yielding a total score from 0 to 44. Higher scores indicate more severe manic symptoms. The outcome is the change in total score at each follow-up assessment relative to baseline, calculated as the follow-up score minus the baseline score. Negative changes indicate improvement.
8 secondary outcomes
Sensitivity of the Diagnostic Model in the Independent Validation Cohort
Time frame: Baseline (at enrollment in the independent validation cohort).
Specificity of the Diagnostic Model in the Independent Validation Cohort
Time frame: Baseline (at enrollment in the independent validation cohort).
Label-Specific Accuracy of the Diagnostic Model in the Independent Validation Cohort
Time frame: Baseline (at enrollment in the independent validation cohort).
Positive Predictive Value of the Diagnostic Model in the Independent Validation Cohort
Time frame: Baseline (at enrollment in the independent validation cohort).
Negative Predictive Value of the Diagnostic Model in the Independent Validation Cohort
Time frame: Baseline (at enrollment in the independent validation cohort).
Change From Baseline in Patient Health Questionnaire-9 (PHQ-9) Score
Time frame: Baseline and 1, 6, 12, 18, 24, 30, and 36 months after baseline.
Change From Baseline in Generalized Anxiety Disorder-7 (GAD-7) Score
Time frame: Baseline and 1, 6, 12, 18, 24, 30, and 36 months after baseline.
Mean Absolute Error of Baseline HAMD-17 Score Estimation in the Independent Validation Cohort
Time frame: Baseline (at enrollment in the independent validation cohort).
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 29 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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?
An observational study of Anxiety Disorders and Depressive Disorder, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 21 inclusion and 13 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 29 Oct 2026. 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 Ming Zheng, PhD (+8619550211701, mingzheng17@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Macro-Averaged Area Under the ROC Curve of the Multimodal Digital Phenotyping-Based Diagnostic Model in the Independent Validation Cohort (time frame: Baseline (at enrollment in the independent validation cohort).). The study lists 4 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 29 Oct 2026.