Depressive DisorderNCT07818057
Validity of the 3-item Patient Health Questionnaire (PHQ-3) for Identifying Moderate-to-Severe Depressive Symptoms Among Elderly Perioperative Patients: A Secondary Analysis of a National Prospective Cohort
An observational study of Depressive Disorder, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
This is a retrospective observational study based on our hospital's prospective peri-operative elderly patient database. We aim to evaluate the correlation between the 9-item Patient Health Questionnaire (PHQ-9) and the brief 3-item Patient Health Questionnaire (PHQ-3) for screening depressive symptoms among elderly… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Depressive Disorder
- What is being tested?
- Retrospective data analysis
- How many people
- 10,536 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2020to 30 Apr 2022
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Elderly surgical patients aged 65 years or older who underwent non-neurosurgical and non-cardiac surgery under general anesthesia and were enrolled in our hospital's prospective perioperative database, with complete perioperative PHQ-3 and PHQ-9 assessments
Who may be able to join
- 1. Aged ≥ 65 years old 2. Patients undergoing surgery under general anesthesia
Who cannot join
- 1. ASA physical status ≥ IV (including ASA class IV) 2. Patients transferred to the intensive care unit (ICU) after surgery 3. Preoperative history of schizophrenia, epilepsy, or Parkinson's disease 4. Diseases requiring corticosteroid therapy for more than 7 days within 1 year before surgery 5. Preoperative inability to communicate (coma, severe dementia, or language/hearing impairment), or MMSE score < 26 6. Any cerebrovascular event within the past 3 years
Trial locations and contacts
1 site in 1 country.
About this study
This is a retrospective observational study based on our hospital's prospective peri-operative elderly patient database. We aim to evaluate the correlation between the 9-item Patient Health Questionnaire (PHQ-9) and the brief 3-item Patient Health Questionnaire (PHQ-3) for screening depressive symptoms among elderly surgical patients. Secondary outcomes include the associations of the two scales with adverse events: 30-day post-operative mortality, readmission, surgical site infection, delirium, and 1-year all-cause mortality. No additional interventions will be performed; only existing routinely-collected clinical data will be analysed.
- Conditions
- Depressive Disorder
- Being tested
- Retrospective data analysis
- Medical subject headings
- Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrospective data analysisOther
No trial-specific intervention. This study is a secondary analysis of existing routine clinical data including PHQ-3 and PHQ-9 scores.
What is being measured
The primary outcome is the main question the study is designed to answer.
1-year all-cause mortality after surgery
Measured: 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start1 Apr 2020
- Primary completion30 Apr 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Chinese PLA General 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
- Other
- Enrolment
- 10,536 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jingsheng Lou, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07818057
- Sponsor's protocol ID
- 301YXM02
- Status last verified
- Sep 2026
- First submitted
- 9 Sep 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity of the 3-item Patient Health Questionnaire (PHQ-3) for Identifying Moderate-to-Severe Depressive Symptoms Among Elderly Perioperative Patients: A Secondary Analysis of a National Prospective Cohort
- ClinicalTrials.gov ID
- NCT07818057
- Acronym / sponsor ID
- 301YXM02
- Conditions
- Depressive Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10,536 participants (actual)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 14 Sep 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 is a retrospective observational study based on our hospital's prospective peri-operative elderly patient database. We aim to evaluate the correlation between the 9-item Patient Health Questionnaire (PHQ-9) and the brief 3-item Patient Health Questionnaire (PHQ-3) for screening depressive symptoms among elderly surgical patients. Secondary outcomes include the associations of the two scales with adverse events: 30-day post-operative mortality, readmission, surgical site infection, delirium, and 1-year all-cause mortality. No additional interventions will be performed; only existing routinely-collected clinical data will be analysed.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Elderly surgical patients aged 65 years or older who underwent non-neurosurgical and non-cardiac surgery under general anesthesia and were enrolled in our hospital's prospective perioperative database, with complete perioperative PHQ-3 and PHQ-9 assessments
Key inclusion criteria (1 listed)
- 1. Aged ≥ 65 years old 2. Patients undergoing surgery under general anesthesia
Key exclusion criteria (1 listed)
- 1. ASA physical status ≥ IV (including ASA class IV) 2. Patients transferred to the intensive care unit (ICU) after surgery 3. Preoperative history of schizophrenia, epilepsy, or Parkinson's disease 4. Diseases requiring corticosteroid therapy for more than 7 days within 1 year before surgery 5. Preoperative inability to communicate (coma, severe dementia, or language/hearing impairment), or MMSE score < 26 6. Any cerebrovascular event within the past 3 years
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 |
|---|---|---|
| Retrospective data analysisNo trial-specific intervention. This study is a secondary analysis of existing routine clinical data including PHQ-3 and PHQ-9 scores. | Other | – |
Primary outcome
1-year all-cause mortality after surgery
Time frame: 12 months after surgery
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 14 Sep 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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, run by Chinese PLA General Hospital 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 1 inclusion and 1 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 14 Sep 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?
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?
1-year all-cause mortality after surgery (time frame: 12 months after surgery). 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 14 Sep 2026.