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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06331572
Other study ID # 1stChongqingMU-TRD
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 1, 2021
Est. completion date December 20, 2023

Study information

Verified date March 2024
Source First Affiliated Hospital of Chongqing Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study contributes new evidence for the identification of adolescent TRD and sheds light on differing pathophysiologies by delineating distinct plasma metabolic profiles between adolescent TRD and FEDN-MDD.


Recruitment information / eligibility

Status Completed
Enrollment 162
Est. completion date December 20, 2023
Est. primary completion date October 25, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 12 Years to 18 Years
Eligibility Inclusion Criteria: FEDN-MDD: 1. Age 12-18 years 2. Meet the diagnostic criteria for MDD according to the DSM-5 3. First-episode and drug-naive 4. HAMD-17 score > 17 TRD: 1. Age 12-18 years 2. Meet the diagnostic criteria for MDD according to the DSM-5 3. HAMD-17 score > 13 4. Currently or previously taking a standard therapeutic dose of antidepressant for at least 6 weeks, and they had at least one historical failure to an antidepressant (reduction in depressive symptoms <50%) HC: 1. age 12-18 years 2. HAMD-17 score < 7 3. HCs without a personal history of a mental illness or family history in a first-degree relative Exclusion Criteria: FEDN-MDD?TRD: 1. the presence or past history of severe medical, neurological or psychiatric disorders (other than MDD in patients) 2. anxiety comorbidity was not considered an exclusion criterion provided that MDD was the main diagnosis and the primary reason for seeking assistance 3. substance abuse, head trauma, or loss of consciousness 4. Chronic physical diseases that significantly affect peripheral metabolism or neurological function 5. Pregnant and lactating women HC: 1. the presence or past history of severe medical, neurological or psychiatric disorders 2. substance abuse, head trauma, or loss of consciousness 3. Chronic physical diseases that significantly affect peripheral metabolism or neurological function 4. Pregnant and lactating women

Study Design


Intervention

Diagnostic Test:
17-HAMD
Patients were interviewed in a semi-structured manner and assessed using the 17-item Hamilton Depression Scale and the Hamilton Anxiety Scale

Locations

Country Name City State
China The First Affiliated Hospital of Chongqing Medical University Chongqing Province

Sponsors (1)

Lead Sponsor Collaborator
First Affiliated Hospital of Chongqing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 17 items Hamilton Depression Scale The Hamilton Depression Scale assesses the level of depressive symptoms in patients baseline
Secondary Hamilton Anxiety Scale The Hamilton Anxiety Scale assesses the level of anxiety symptoms in patients baseline
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