Major Depressive DisorderNCT04986124
Quality of Life in Chinese Working and School Age Population With MDD
An observational study of Major Depressive Disorder and Remission, run by Shanghai Mental Health Center at 1 site in China.
Trial summary
Major depressive disorder (MDD) is a common mental illness with high prevalence and global burden. Previous studies revealed that over 70% patients in remission still had decreased quality of life, severe function impairment, low positive mental health score and poor coping ability. Read more about this study
- Who is it for?
- Ages 16 to 50 years
- Conditions the study is for
- Major Depressive Disorder, Remission
- What is being tested?
- treatment as usual
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2021to 30 Aug 2021
- How long will I take part?
- 1 Day
- 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 16 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients with MDD in working and school age who recieved medication treatment and achieved remission for at leat 8 weeks.
Who may be able to join
- Out-patients;
- Men or women aged between 16 and 50, with junior high school education or above;
- According to medical history, patients should be diagnosed with major depressive episode by two or above psychiatric doctors based on ICD-10 criteria;
- According to assessment, patients should meet the DSM-5 criteria for MDD when in past episodes;
- Patients received stable ant-depression medication treatment for at least 8 weeks before enrolment;
- 17-item HAMD total score ≤ 7;
- Willing to participate in this study, and sign an informed consent.
Who cannot join
- HCL-32 total score < 12;
- Diagnosed with bipolar disorder;
- Suffering from some serious physical diseases (e.g. moderate or severe brain injury, central nervous system diseases, or other unstable physical condition affecting the whole body) adversely affects the performance on neuropsychological test or rating scales;
- Received ECT in the past 6 months.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Mental Health Center
Shanghai
Jun Chen, M.D., Ph.D, 021-34773367, doctorcj2010@gmail.com
About this study
Official title: A Survey of Quality of Life in Chinese Working and School Age Population With Major Depressive Disorder
Major depressive disorder (MDD) is a common mental illness with high prevalence and global burden. Previous studies revealed that over 70% patients in remission still had decreased quality of life, severe function impairment, low positive mental health score and poor coping ability. However, few studies focus on working and school age patients with MDD. A GBD survey showed that over 40% MDD patients are 15-50 years old. Therefore, we initiate the present multi-center cross-sectional survey to investigate the associations between clinical symptoms, cognitive function, occupational/study ability, and quality of life in Chinese working and school age population with MDD who are in remission.
Read the detailed description
This is a multi-center cross-sectional study. Patients with MDD who received medication treatment and achieved remission for at least 8 weeks will be enrolled. For all the participants, demographic information will be collected; clinical symptoms, cognitive function, occupational/study ability, and quality of life will be evaluated by using 17-items HAMD, PHQ-9, HAMA, PSQI, SHAPS, HCL-32, SDS, LEAPS, QOL-6, PFQ and THINC-it toolkit.
- Conditions
- Major Depressive Disorder, Remission
- Being tested
- treatment as usual
- Keywords
- cognitive function, social function, quality of life, working and school age population
- Medical subject headings
- Depressive Disorder, Major, Social Adjustment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
treatment as usualOther
No inervention. Treatment regime remains unchanged.
| Study group | Role | What they receive |
|---|---|---|
| MDD patients | No intervention. Receives: Other: treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Sheehan disability scale (SDS)
To evaluate the functional impairment, including work/study, daily life and family responsibility. The score of each subscale ranged from 0 to 10 which means from no impairment to loss of function.
Measured: up to 1 weeks
Quality of Life, short form 6 (QOL-6)
To evaluate the quality of life in patients with MDD. The higher the total score, the better the quality of life.
Measured: up to 4 weeks
The Psychosocial Function Questionnaire in Patients with Depression (PFQ)
To evaluate the psychosocial function of patients with MDD. The lower total score means the severer psychosocial function impairment.
Measured: up to 1 weeks
Secondary outcomes (7)
The Lam Employment Absence and Productivity Scale (LEAPS)
To evaluate the work capacity. The higher total score means the severer impairment of work capacity.
Measured: up to 2 weeks
The Hamilton Depression Scale-17 items (HAMD)
To evaluate the severity of depressive symptoms by clinicians. Remission: total score < 7.
Measured: up to 1 weeks
Patient Health Questionnaire-9 (PHQ-9)
to evaluate the severity of depressive symptoms by patients. Remission: total score < 4.
Measured: up to 2 weeks
The Hamilton Anxiety Scale (HAMA)
To evaluate the severity of anxiety symptoms by clinicians. The total score < 6: no anxiety sympotom.
Measured: up to 1 weeks
Pittsburgh Sleep Quality Index (PSQI)
To evaluate the sleep quality. The lower the total score, the better sleep quality (<5).
Measured: up to 4 weeks
The Snaith-Hamilton Pleasure Scale (SHAPS)
To evaluate the severity of anhedonia. The higher total score means the severer of anhedonia.
Measured: up to 4 weeks
THINC-it toolkit
To assess the cognitive function in patients with MDD specifically. The composite THINC-it tool score is the integrated total score of results from performance on five sub-component cognitive tests of the THINC-it tool.
Measured: up to 1 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2021
- Study start1 Apr 2021
- Primary completion30 Aug 2021 (estimated)
- Study completion30 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Shanghai Mental Health CenterThe 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing HuiLongGuan Hospital, Huaxi Hospital, Second Xiangya Hospital of Central South University, The Affiliated Brain Hospital of Nanjing Medical University, Guangzhou Psychiatric Hospital, First Affiliated Hospital Xi'an Jiaotong University
- Responsible party
- Sponsor
- Investigators
- Jun Chen, M.D., Ph.D, Principal investigator, Shanghai Mental Health Center (SMHC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04986124
- Sponsor's protocol ID
- 2020-76
- Status last verified
- Apr 2021
- First submitted
- 8 Apr 2021
- Last updated
- 2 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Survey of Quality of Life in Chinese Working and School Age Population With Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT04986124
- Acronym / sponsor ID
- 2020-76
- Conditions
- Major Depressive Disorder, Remission
- Keywords
- cognitive function, social function, quality of life, working and school age population
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Collaborators
- Beijing HuiLongGuan Hospital, Huaxi Hospital, Second Xiangya Hospital of Central South University, The Affiliated Brain Hospital of Nanjing Medical University, Guangzhou Psychiatric Hospital, First Affiliated Hospital Xi'an Jiaotong University
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 30 Aug 2021 (estimated)
- Study completion
- 30 Aug 2021 (estimated)
- First posted
- 2 Aug 2021 (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.
Major depressive disorder (MDD) is a common mental illness with high prevalence and global burden. Previous studies revealed that over 70% patients in remission still had decreased quality of life, severe function impairment, low positive mental health score and poor coping ability. However, few studies focus on working and school age patients with MDD. A GBD survey showed that over 40% MDD patients are 15-50 years old. Therefore, we initiate the present multi-center cross-sectional survey to investigate the associations between clinical symptoms, cognitive function, occupational/study ability, and quality of life in Chinese working and school age population with MDD who are in remission.
Detailed description
This is a multi-center cross-sectional study. Patients with MDD who received medication treatment and achieved remission for at least 8 weeks will be enrolled. For all the participants, demographic information will be collected; clinical symptoms, cognitive function, occupational/study ability, and quality of life will be evaluated by using 17-items HAMD, PHQ-9, HAMA, PSQI, SHAPS, HCL-32, SDS, LEAPS, QOL-6, PFQ and THINC-it toolkit.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MDD patients | – | Other: treatment as usualNo intervention. |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients with MDD in working and school age who recieved medication treatment and achieved remission for at leat 8 weeks.
Key inclusion criteria (7 listed)
- Out-patients;
- Men or women aged between 16 and 50, with junior high school education or above;
- According to medical history, patients should be diagnosed with major depressive episode by two or above psychiatric doctors based on ICD-10 criteria;
- According to assessment, patients should meet the DSM-5 criteria for MDD when in past episodes;
- Patients received stable ant-depression medication treatment for at least 8 weeks before enrolment;
Key exclusion criteria (4 listed)
- HCL-32 total score < 12;
- Diagnosed with bipolar disorder;
- Suffering from some serious physical diseases (e.g. moderate or severe brain injury, central nervous system diseases, or other unstable physical condition affecting the whole body) adversely affects the performance on neuropsychological test or rating scales;
- Received ECT in the past 6 months.
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 |
|---|---|---|
| treatment as usualNo inervention. Treatment regime remains unchanged. | Other | MDD patients |
Primary outcome
The Sheehan disability scale (SDS)
Time frame: up to 1 weeks
To evaluate the functional impairment, including work/study, daily life and family responsibility. The score of each subscale ranged from 0 to 10 which means from no impairment to loss of function.
Quality of Life, short form 6 (QOL-6)
Time frame: up to 4 weeks
To evaluate the quality of life in patients with MDD. The higher the total score, the better the quality of life.
The Psychosocial Function Questionnaire in Patients with Depression (PFQ)
Time frame: up to 1 weeks
To evaluate the psychosocial function of patients with MDD. The lower total score means the severer psychosocial function impairment.
7 secondary outcomes
The Lam Employment Absence and Productivity Scale (LEAPS)
Time frame: up to 2 weeks
The Hamilton Depression Scale-17 items (HAMD)
Time frame: up to 1 weeks
Patient Health Questionnaire-9 (PHQ-9)
Time frame: up to 2 weeks
The Hamilton Anxiety Scale (HAMA)
Time frame: up to 1 weeks
Pittsburgh Sleep Quality Index (PSQI)
Time frame: up to 4 weeks
The Snaith-Hamilton Pleasure Scale (SHAPS)
Time frame: up to 4 weeks
THINC-it toolkit
Time frame: up to 1 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2021.
- 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.
Jun Chen, M.D., Ph.D principal investigator
Shanghai Mental Health Center (SMHC)
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 Major Depressive Disorder and Remission, run by Shanghai Mental Health Center 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 7 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 2 Aug 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jun Chen, M.D., Ph.D (021-34773367, doctorcj2010@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Sheehan disability scale (SDS) (time frame: up to 1 weeks). The study lists 3 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 2 Aug 2021.