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

• Conditions: Remission; Major Depressive Disorder
• Interventions: Other: treatment as usual

• Registration Number: NCT04986124
• Lead Sponsor: Shanghai Mental Health Center

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.

Study Timeline

• Status Verified: 2021-04
• Study Start: 2021-04-01
• Study First Submitted: 2021-04-08
• Study First Submitted QC: 2021-07-22
• Last Update Submitted: 2021-07-22
• Study First Posted: 2021-08-02
• Last Update Posted: 2021-08-02
• Primary Completion: 2021-08-30
• Study Completion: 2021-08-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MDD patients	treatment as usual	No intervention.

Primary Outcome Measures

Name	Time	Method
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.
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.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Shanghai Mental Health Center; 🇨🇳 Shanghai, China