Depressive Disorder, MajorNCT05267873
Combining Data Sources to Identify Effect Moderation for Personalized Mental Health
An observational study of Depressive Disorder, Major, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
Trial summary
This work will extend and apply methods for modeling heterogeneous treatment effects when multiple studies are available, with a particular focus on the complexities in mental health research. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depressive Disorder, Major
- What is being tested?
- Duloxetine, Vortioxetine
- How many people
- 9,586 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2015to 1 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Adult, Older adult
Study population: Patients who received Duloxetine or Vortioxetine
Who may be able to join
- All patients prescribed any Duloxetine or Vortioxetine in the health systems between 01/01/2015 - 12/31/2021.
- AND from patients with at least 1-year historical EHR data (burn-in period) without prescribing any of the two medications. During the burn-in period, patients should have at least one encounter in the system, and with no encounters during that time frame when they were prescribed Duloxetine or Vortioxetine.
- AND patients age 18-65 years old at baseline.
- Male or female
- Age 18 years or older
- Major depressive episode according to Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR) classification code 296.3x
- Montgomery-Asberg Depression Rating Scale (MADRS) total score ≥ 26
- Clinical Global Impression - Severity (CGI-S) scale score ≥ 4
Who cannot join
- Patients prescribed both Duloxetine and Vortioxetine at baseline would be removed.
- 4 randomized controlled trials (RCTs)
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Bloomberg School of Public Health
Baltimore, Maryland, 21205
About this study
This work will extend and apply methods for modeling heterogeneous treatment effects when multiple studies are available, with a particular focus on the complexities in mental health research. The methods will be illustrated in examples estimating the effects of medical treatments for major depressive disorder (duloxetine and vortioxetine) using 4 randomized controlled trials (available in the Vivli trials resource) and non-experimental data from the Duke University Health System electronic health record and the Johns Hopkins Health System electronic health record systems.
- Conditions
- Depressive Disorder, Major
- Being tested
- Duloxetine, Vortioxetine
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Duloxetine, VortioxetineDrug
Medications for major depressive disorder
| Study group | Role | What they receive |
|---|---|---|
| Duke Health System Electronic Health Record | Patients who received Duloxetine or Vortioxetine Receives: Drug: Duloxetine, Vortioxetine | |
| Johns Hopkins Health System Electronic Health Record | Patients who received Duloxetine or Vortioxetine Receives: Drug: Duloxetine, Vortioxetine | |
| Randomized Controlled Trial 1 (NCT01153009) | Patients who received Duloxetine or Vortioxetine Receives: Drug: Duloxetine, Vortioxetine | |
| Randomized Controlled Trial 2 (NCT01140906) | Patients who received Duloxetine or Vortioxetine Receives: Drug: Duloxetine, Vortioxetine | |
| Randomized Controlled Trial 3 (NCT00672620) | Patients who received Duloxetine or Vortioxetine Receives: Drug: Duloxetine, Vortioxetine | |
| Randomized Controlled Trial 4 (NCT00635219) | Patients who received Duloxetine or Vortioxetine Receives: Drug: Duloxetine, Vortioxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
9-question Patient Health Questionnaire (PHQ-9) or PHQ-2 scores
Higher score indicates greater severity of major depressive disorder.
Measured: 6 months
9-question Patient Health Questionnaire (PHQ-9) or PHQ-2 scores
Higher score indicates greater severity of major depressive disorder.
Measured: 1 year
Secondary outcomes (4)
Emergency room visits or inpatient admissions with diagnosis of depression or suicidality
A binary outcome equals to 'Yes' if the patient ever had any emergency department or inpatient hospital admission encounter with depression or suicidality International Classification of Diseases (ICD) codes, otherwise equals to "No".
Measured: 6 months
Emergency room visits or inpatient admissions with diagnosis of depression or suicidality
A binary outcome equals to 'Yes' if the patient ever had any emergency department or inpatient hospital admission encounter with depression or suicidality International Classification of Diseases (ICD) codes, otherwise equals to "No".
Measured: 1 year
Emergency room visits or inpatient admissions for any reason
A binary outcome equals to 'Yes' if the patient ever had any emergency department or inpatient hospital admission encounter after the prescription, otherwise equals to "No".
Measured: 6 months
Emergency room visits or inpatient admissions for any reason
A binary outcome equals to 'Yes' if the patient ever had any emergency department or inpatient hospital admission encounter after the prescription, otherwise equals to "No".
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2022
- Study start1 Jan 2015
- Primary completion31 Dec 2021
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Depressive Disorder, MajorStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 9,586 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- Duke University, Patient-Centered Outcomes Research Institute, National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Elizabeth Stuart, PhD, Principal investigator, Johns Hopkins Bloomberg School of Public HealthHwanhee Hong, PhD, Principal investigator, Department of Biostatistics & Bioinformatics, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05267873
- Sponsor's protocol ID
- IRB00017538
- Status last verified
- Apr 2026
- First submitted
- 20 Feb 2022
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hua K, Wojdyla D, Carnicelli A, Granger C, Wang X, Hong H. Network Meta-Analysis With Individual Participant-Level Data of Time-to-Event Outcomes Using Cox Regression. Stat Med. 2025 Feb 28;44(5):e70027. doi: 10.1002/sim.70027.
PubMed 39964207Hua K, Wang X, Hong H. Network Meta-Analysis of Time-to-Event Endpoints With Individual Participant Data Using Restricted Mean Survival Time Regression. Biom J. 2025 Feb;67(1):e70037. doi: 10.1002/bimj.70037.
PubMed 39967285Brantner CL, Nguyen TQ, Parikh H, Zhao C, Hong H, Stuart EA. Precision Mental Health: Predicting Heterogeneous Treatment Effects for Depression through Data Integration. J R Stat Soc Ser C Appl Stat. 2025 Dec 12:10.1093/jrsssc/qlaf068. doi: 10.1093/jrsssc/qlaf068. Online ahead of print.
PubMed 41496761Brantner CL, Nguyen TQ, Tang T, Zhao C, Hong H, Stuart EA. Comparison of methods that combine multiple randomized trials to estimate heterogeneous treatment effects. Stat Med. 2024 Mar 30;43(7):1291-1314. doi: 10.1002/sim.9955. Epub 2024 Jan 25.
PubMed 38273647Brantner CL, Yu W, Zhao C, Jeon K, Ringlein GV, Wang Q, Lemoto E, Nguyen TQ, Gagliardi JP, Zandi PP, Goldstein BA, Stuart EA, Hong H. The challenges of integrating diverse data sources: A case study in major depression. Health Serv Outcomes Res Methodol. 2024 Oct 23:10.1007/s10742-025-00363-8. doi: 10.1007/s10742-025-00363-8. Online ahead of print.
PubMed 41669555Brantner CL, Chang TH, Nguyen TQ, Hong H, Stefano LD, Stuart EA. Methods for Integrating Trials and Non-experimental Data to Examine Treatment Effect Heterogeneity. Stat Sci. 2023 Nov;38(4):640-654. doi: 10.1214/23-sts890. Epub 2023 Nov 6.
PubMed 38638306
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combining Data Sources to Identify Effect Moderation for Personalized Mental Health
- ClinicalTrials.gov ID
- NCT05267873
- Acronym / sponsor ID
- IRB00017538
- Conditions
- Depressive Disorder, Major
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9,586 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- Duke University, Patient-Centered Outcomes Research Institute, National Institute of Mental Health (NIMH)
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 4 Mar 2022 (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 work will extend and apply methods for modeling heterogeneous treatment effects when multiple studies are available, with a particular focus on the complexities in mental health research. The methods will be illustrated in examples estimating the effects of medical treatments for major depressive disorder (duloxetine and vortioxetine) using 4 randomized controlled trials (available in the Vivli trials resource) and non-experimental data from the Duke University Health System electronic health record and the Johns Hopkins Health System electronic health record systems.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Duke Health System Electronic Health Record | – | Drug: Duloxetine, VortioxetinePatients who received Duloxetine or Vortioxetine |
| Johns Hopkins Health System Electronic Health Record | – | Drug: Duloxetine, VortioxetinePatients who received Duloxetine or Vortioxetine |
| Randomized Controlled Trial 1 (NCT01153009) | – | Drug: Duloxetine, VortioxetinePatients who received Duloxetine or Vortioxetine |
| Randomized Controlled Trial 2 (NCT01140906) | – | Drug: Duloxetine, VortioxetinePatients who received Duloxetine or Vortioxetine |
| Randomized Controlled Trial 3 (NCT00672620) | – | Drug: Duloxetine, VortioxetinePatients who received Duloxetine or Vortioxetine |
| Randomized Controlled Trial 4 (NCT00635219) | – | Drug: Duloxetine, VortioxetinePatients who received Duloxetine or Vortioxetine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients who received Duloxetine or Vortioxetine
Key inclusion criteria (8 listed)
- All patients prescribed any Duloxetine or Vortioxetine in the health systems between 01/01/2015 - 12/31/2021.
- AND from patients with at least 1-year historical EHR data (burn-in period) without prescribing any of the two medications. During the burn-in period, patients should have at least one encounter in the system, and with no encounters during that time frame when they were prescribed Duloxetine or Vortioxetine.
- AND patients age 18-65 years old at baseline.
- Male or female
- Age 18 years or older
Key exclusion criteria (2 listed)
- Patients prescribed both Duloxetine and Vortioxetine at baseline would be removed.
- 4 randomized controlled trials (RCTs)
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 |
|---|---|---|
| Duloxetine, VortioxetineMedications for major depressive disorder | Drug | Duke Health System Electronic Health Record, Johns Hopkins Health System Electronic Health Record, Randomized Controlled Trial 1 (NCT01153009), Randomized Controlled Trial 2 (NCT01140906), Randomized Controlled Trial 3 (NCT00672620), Randomized Controlled Trial 4 (NCT00635219) |
Primary outcome
9-question Patient Health Questionnaire (PHQ-9) or PHQ-2 scores
Time frame: 6 months
Higher score indicates greater severity of major depressive disorder.
9-question Patient Health Questionnaire (PHQ-9) or PHQ-2 scores
Time frame: 1 year
Higher score indicates greater severity of major depressive disorder.
4 secondary outcomes
Emergency room visits or inpatient admissions with diagnosis of depression or suicidality
Time frame: 6 months
Emergency room visits or inpatient admissions with diagnosis of depression or suicidality
Time frame: 1 year
Emergency room visits or inpatient admissions for any reason
Time frame: 6 months
Emergency room visits or inpatient admissions for any reason
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Results publication: PubMed 39964207Hua K, Wojdyla D, Carnicelli A, Granger C, Wang X, Hong H. Network Meta-Analysis With Individual Participant-Level Data of Time-to-Event Outcomes Using Cox Regression. Stat Med. 2025 Feb 28;44(5):e70027. doi: 10.1002/sim.70027.
- Results publication: PubMed 39967285Hua K, Wang X, Hong H. Network Meta-Analysis of Time-to-Event Endpoints With Individual Participant Data Using Restricted Mean Survival Time Regression. Biom J. 2025 Feb;67(1):e70037. doi: 10.1002/bimj.70037.
- Results publication: PubMed 41496761Brantner CL, Nguyen TQ, Parikh H, Zhao C, Hong H, Stuart EA. Precision Mental Health: Predicting Heterogeneous Treatment Effects for Depression through Data Integration. J R Stat Soc Ser C Appl Stat. 2025 Dec 12:10.1093/jrsssc/qlaf068. doi: 10.1093/jrsssc/qlaf068. Online ahead of print.
- Results publication: PubMed 38273647Brantner CL, Nguyen TQ, Tang T, Zhao C, Hong H, Stuart EA. Comparison of methods that combine multiple randomized trials to estimate heterogeneous treatment effects. Stat Med. 2024 Mar 30;43(7):1291-1314. doi: 10.1002/sim.9955. Epub 2024 Jan 25.
- Results publication: PubMed 41669555Brantner CL, Yu W, Zhao C, Jeon K, Ringlein GV, Wang Q, Lemoto E, Nguyen TQ, Gagliardi JP, Zandi PP, Goldstein BA, Stuart EA, Hong H. The challenges of integrating diverse data sources: A case study in major depression. Health Serv Outcomes Res Methodol. 2024 Oct 23:10.1007/s10742-025-00363-8. doi: 10.1007/s10742-025-00363-8. Online ahead of print.
- Results publication: PubMed 38638306Brantner CL, Chang TH, Nguyen TQ, Hong H, Stefano LD, Stuart EA. Methods for Integrating Trials and Non-experimental Data to Examine Treatment Effect Heterogeneity. Stat Sci. 2023 Nov;38(4):640-654. doi: 10.1214/23-sts890. Epub 2023 Nov 6.
- 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. This study is not recruiting at the moment.
Elizabeth Stuart, PhD principal investigator
Johns Hopkins Bloomberg School of Public Health
Hwanhee Hong, PhD principal investigator
Department of Biostatistics & Bioinformatics, Duke University
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 Depressive Disorder, Major, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
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 8 inclusion and 2 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: finished, as of the sponsor's last update on 13 Apr 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
9-question Patient Health Questionnaire (PHQ-9) or PHQ-2 scores (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05267873, which also lists 6 linked publications.
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 13 Apr 2026.