Exploring Blood Plasma Metabolomics: Unraveling the Metabolic Landscape in Treatment-Resistant Adolescent Depression

Major Depressive Disorder Clinical Trial

Official title:

Exploring Blood Plasma Metabolomics: Unraveling the Metabolic Landscape in Treatment-Resistant Adolescent Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06331572
• Other study ID #: 1stChongqingMU-TRD
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder
• Mental Disorders
• Metabolic Diseases
• Metabolic Disorder
• Problem Behavior
• Psychiatric Disorder

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