Quality of Life in Chinese Working and School Age Population With MDD

Sponsor

Shanghai Mental Health Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT04986124

Collaborator

Beijing HuiLongGuan Hospital (Other), Huaxi Hospital (Other), Second Xiangya Hospital, Central South University (Other), Nanjing Brain Hospital, Nanjing Medical University (Other), Guangzhou Psychiatric Hospital (Other), The First Affiliated Hospital of Medical College, Xi'an Jiaotong University (Other)

500

Enrollment

Location

Anticipated Duration (Months)

100.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Disorder Remission	Other: treatment as usual

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

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

500 participants

Observational Model:

Case-Only

Time Perspective:

Cross-Sectional

Official Title:

A Survey of Quality of Life in Chinese Working and School Age Population With Major Depressive Disorder

Actual Study Start Date :

Apr 1, 2021

Anticipated Primary Completion Date :

Aug 30, 2021

Anticipated Study Completion Date :

Aug 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
MDD patients No intervention.	Other: treatment as usual No inervention. Treatment regime remains unchanged.

Arm

Intervention/Treatment

MDD patients

No intervention.

Other: treatment as usual

No inervention. Treatment regime remains unchanged.

Outcome Measures

Primary Outcome Measures

The Sheehan disability scale (SDS) [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) [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) [up to 1 weeks]
To evaluate the psychosocial function of patients with MDD. The lower total score means the severer psychosocial function impairment.

Secondary Outcome Measures

The Lam Employment Absence and Productivity Scale (LEAPS) [up to 2 weeks]
To evaluate the work capacity. The higher total score means the severer impairment of work capacity.
The Hamilton Depression Scale-17 items (HAMD) [up to 1 weeks]
To evaluate the severity of depressive symptoms by clinicians. Remission: total score < 7.
Patient Health Questionnaire-9 (PHQ-9) [up to 2 weeks]
to evaluate the severity of depressive symptoms by patients. Remission: total score < 4.
The Hamilton Anxiety Scale (HAMA) [up to 1 weeks]
To evaluate the severity of anxiety symptoms by clinicians. The total score < 6: no anxiety sympotom.
Pittsburgh Sleep Quality Index (PSQI) [up to 4 weeks]
To evaluate the sleep quality. The lower the total score, the better sleep quality (<5).
The Snaith-Hamilton Pleasure Scale (SHAPS) [up to 4 weeks]
To evaluate the severity of anhedonia. The higher total score means the severer of anhedonia.
THINC-it toolkit [up to 1 weeks]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.