Trial · NCT07903246
A Prospective Study of Anxiety, Depression, and Bipolar Disorder in People
NCT07903246, Recruiting, Second Affiliated Hospital, Zhejiang University, School of Medicine
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Prospective Study of Anxiety, Depression, and Bipolar Disorder in People. Trials, record NCT07903246. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07903246
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Prospective Study of Anxiety, Depression, and Bipolar Disorder in People
- NCT number
- NCT07903246
- Status
- Recruiting
- Enrollment
- 2,690 participants, estimated
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Conditions
- Anxiety Disorders, Depressive Disorder, Bipolar Disorder (BD)
- First posted
- 2026-10-29
- Last updated
- 2026-10-29
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Macro-Averaged Area Under the ROC Curve of the Multimodal Digital Phenotyping-Based Diagnostic Model in the Independent Validation Cohort | 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. |
| Primary | Change From Baseline in 17-Item Hamilton Depression Rating Scale (HAMD-17) Score | 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. |
| Primary | Change From Baseline in 14-Item Hamilton Anxiety Rating Scale (HAMA-14) Score | 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. |
| Primary | Change From Baseline in Bech-Rafaelsen Mania Rating Scale (BRMS) Score in the Bipolar Disorder Group | 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. |
| Secondary | Sensitivity of the Diagnostic Model in the Independent Validation Cohort | Baseline (at enrollment 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. |
| Secondary | Specificity of the Diagnostic Model in the Independent Validation Cohort | Baseline (at enrollment 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. |
| Secondary | Label-Specific Accuracy of the Diagnostic Model in the Independent Validation Cohort | Baseline (at enrollment 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. |
| Secondary | Positive Predictive Value of the Diagnostic Model in the Independent Validation Cohort | Baseline (at enrollment 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. |
| Secondary | Negative Predictive Value of the Diagnostic Model in the Independent Validation Cohort | Baseline (at enrollment 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. |
| Secondary | Change From Baseline in Patient Health Questionnaire-9 (PHQ-9) Score | Baseline and 1, 6, 12, 18, 24, 30, and 36 months after baseline. | 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. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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