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

NCT04986124 | Unknown DMC

• 1 other identifier: 2020-76
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder; Remission

Keywords

cognitive function; social function; quality of life; working and school age population

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (7)

• The Lam Employment Absence and Productivity Scale (LEAPS)

  up to 2 weeks

• The Hamilton Depression Scale-17 items (HAMD)

  up to 1 weeks

• Patient Health Questionnaire-9 (PHQ-9)

  up to 2 weeks

• The Hamilton Anxiety Scale (HAMA)

  up to 1 weeks

• Pittsburgh Sleep Quality Index (PSQI)

  up to 4 weeks

Study Arms (1)

MDD patients

No intervention.

Other: treatment as usual

Interventions

treatment as usual OTHER

No inervention. Treatment regime remains unchanged.

MDD patients

Eligibility Criteria

• Age: 16 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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;
• item HAMD total score ≤ 7;
• Willing to participate in this study, and sign an informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Mental Health Center: lead
• Beijing HuiLongGuan Hospital: collaborator
• Huaxi Hospital: collaborator
• Second Xiangya Hospital of Central South University: collaborator
• Nanjing Brain Hospital, Nanjing Medical University: collaborator
• Guangzhou Psychiatric Hospital: collaborator
• First Affiliated Hospital Xi'an Jiaotong University: collaborator

Study Sites (1)

Shanghai Mental Health Center

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major; Social Adjustment

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Social Behavior; Behavior

Study Officials

• Jun Chen, M.D., Ph.D

  Shanghai Mental Health Center (SMHC)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun Chen, M.D., Ph.D

CONTACT

021-34773367; doctorcj2010@gmail.com

Tao Yang, M.D.

CONTACT

+86 15800579832; yangtao2015sjtu@foxmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2021
• First Posted: August 2, 2021
• Study Start: April 1, 2021
• Primary Completion: August 30, 2021
• Study Completion: August 30, 2021
• Last Updated: August 2, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)