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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05535270
Other study ID # IIT20220240B-R1
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2022
Est. completion date June 30, 2023

Study information

Verified date September 2023
Source First Affiliated Hospital of Zhejiang University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Mood disorders are a group of psychiatric disorders that can affect a person's mood, energy, and motivation. Emotional blunting has been observed in clinical practice in patients with mood disorders. Emotional blunting has a negative impact on patients' overall treatment and leads to poorer adherence. The Oxford Depression Questionnaire (ODQ) is a measuring instrument of emotional blunting. The ODQ is expected to be a scientifically valid tool for detecting emotional blunting. The ODQ has high construct validity and internal reliability. However, no scientific validity studies have been conducted on ODQ in Chinese population. Therefore, this study is intended to investigate the reliability and validity of the ODQ in Chinese patients with mood disorders.


Recruitment information / eligibility

Status Completed
Enrollment 272
Est. completion date June 30, 2023
Est. primary completion date June 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 13 Years to 65 Years
Eligibility Inclusion Criteria: 1) both biological parents were Han Chinese; 2) currently diagnosed with major depressive disorder or bipolar disorder according to the Mini International Neuropsychiatric Interview for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition; 3) aged 13-65 years; 4) can complete the self-assessment questionnaires. Exclusion Criteria: 1) currently diagnosed with neurological diseases or other major psychiatric disorders, e.g., schizophrenia, cognitive impairment, substance abuse; 2) diagnosed with severe somatic illnesses, such as diabetes and cardiovascular diseases;

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Oxford Depression Questionnaire (ODQ)
The Oxford Depression Questionnaire (ODQ)is a patient-centered questionnaire. The scale contains three sections: i) the patient's experience in the past week; ii) the patient's experience before the illness worsened, and iii) the patient's emotional feelings about receiving antidepressant treatment. The 26-item questionnaire contains four dimensions of "emotional blunting": not caring (NC), emotional detachment from others (ED), reduction in positive emotions (RP), and general reduction in emotions (GR). Patients not taking antidepressants were only required to rate the first two sections .

Locations

Country Name City State
China Department of Psychiatry, First Affiliated Hospital of Zhejiang University Hangzhou Zhejiang

Sponsors (1)

Lead Sponsor Collaborator
First Affiliated Hospital of Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Oxford Depression Questionnaire (ODQ) To analyze reliability and validity of the ODQ. baseline
Secondary Beck Depression Inventory-II (BDI-II) To analyze criterion validity of the Chinese version of the ODQ baseline
Secondary Montgomery-Asberg Depression Rating Scale (MADRS) To analyze correlation with ODQ baseline
Secondary Oxford Depression Questionnaire (ODQ) To analyze Test-retest reliability coefficients of the ODQ. 2 weeks after baseline
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