Clinical trial NCT04986124: Quality of Life in Chinese Working and School Age Population With MDD
Official title: A Survey of Quality of Life in Chinese Working and School Age Population With Major Depressive Disorder
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Major Depressive Disorder
Remission
Keywords: cognitive function
social function
quality of life
working and school age population
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
Collaborators: name: Beijing HuiLongGuan Hospital
name: Huaxi Hospital
name: Second Xiangya Hospital, Central South University
name: Nanjing Brain Hospital, Nanjing Medical University
name: Guangzhou Psychiatric Hospital
name: First Affiliated Hospital Xi'an Jiaotong University
First posted: 2021-08-02
Enrollment: 500
Sex: ALL
Minimum age (years): 16
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with MDD in working and school age who recieved medication treatment and achieved remission for at leat 8 weeks.

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: The Sheehan disability scale (SDS)
timeFrame: up to 1 weeks
measure: Quality of Life, short form 6 (QOL-6)
timeFrame: up to 4 weeks
measure: The Psychosocial Function Questionnaire in Patients with Depression (PFQ)
timeFrame: up to 1 weeks
Secondary outcomes:
measure: The Lam Employment Absence and Productivity Scale (LEAPS)
timeFrame: up to 2 weeks
measure: The Hamilton Depression Scale-17 items (HAMD)
timeFrame: up to 1 weeks
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: up to 2 weeks
measure: The Hamilton Anxiety Scale (HAMA)
timeFrame: up to 1 weeks
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: up to 4 weeks
measure: The Snaith-Hamilton Pleasure Scale (SHAPS)
timeFrame: up to 4 weeks
measure: THINC-it toolkit
timeFrame: up to 1 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Mental Health Center
Study officials:
affiliation: Shanghai Mental Health Center (SMHC)
name: Jun Chen, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References: