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

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04986124
• Other study ID #: 2020-76
• Status: Recruiting
• Start date: April 1, 2021
• Est. completion date: August 30, 2021

Study information

• Verified date: April 2021
• Source: Shanghai Mental Health Center
• Contact: Jun Chen, M.D., Ph.D
• Phone: 021-34773367
• Email: doctorcj2010[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: August 30, 2021
• Est. primary completion date: August 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder
• Remission

Intervention

Other:
• treatment as usual
No inervention. Treatment regime remains unchanged.

Locations

Country	Name	City	State
China	Shanghai Mental Health Center	Shanghai

Sponsors (7)

Lead Sponsor	Collaborator
Shanghai Mental Health Center	Beijing HuiLongGuan Hospital, Guangzhou Psychiatric Hospital, Huaxi Hospital, Nanjing Brain Hospital, Nanjing Medical University, Second Xiangya Hospital, Central South University, The First Affiliated Hospital of Medical College, Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

Outcome

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