Registered outcomes15

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

1 to 15 of 15

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.
Secondary	Change From Baseline in Generalized Anxiety Disorder-7 (GAD-7) Score	Baseline and 1, 6, 12, 18, 24, 30, and 36 months after baseline.	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.
Secondary	Mean Absolute Error of Baseline HAMD-17 Score Estimation in the Independent Validation Cohort	Baseline (at enrollment 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.
Other	Mean Absolute Error of Future HAMD-17 Score Prediction Using Baseline Digital Phenotyping Data	1, 6, 12, 18, 24, 30, and 36 months after baseline.	Exploratory models will use baseline multimodal digital phenotyping data to predict HAMD-17 total scores at subsequent follow-up visits. Predictive performance will be evaluated separately at each follow-up time point using mean absolute error (MAE), calculated as the mean absolute difference between predicted and observed HAMD-17 scores. MAE will be expressed in HAMD-17 score points, with lower values indicating better prediction accuracy. Feature selection, parameter tuning, and model training will be performed within the development cohort. Models will be fixed before evaluation in the independent validation cohort. Only information available at baseline will be used as predictor inputs.
Other	Plasma Metabolite Abundance Profiles	Baseline.	Exploratory plasma metabolomic profiling will be performed using untargeted liquid chromatography-mass spectrometry (LC-MS). The outcome will be the normalized abundance of individual metabolite features after analytical quality control and data preprocessing. Metabolite abundances will be reported separately rather than combined into a composite score. Exploratory analyses will examine associations between metabolite abundances and concurrently assessed HAMD-17 and HAMA-14 total scores.
Other	Relative Abundance Profiles of Gut Microbial Species	Baseline	Exploratory gut microbiome profiling will be performed. The outcome will be the relative abundance of individual microbial species after sequencing quality control and taxonomic profiling, expressed as the proportion of the microbial community assigned to each species. Species-level abundances will be reported separately rather than combined into a composite score. Exploratory analyses will examine associations between microbial species relative abundances and concurrently assessed HAMD-17 and HAMA-14 total scores.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

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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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