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

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.

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder; Psychiatric Disorder; Metabolic Disorder
• Intervention / Treatment: Diagnostic test: 17-HAMD

• Study Type: Observational
• Enrollment (Actual): 162

Contacts and Locations

Study Locations

• China
  • Province
    • Chongqing, Province, China, 400000
      • The First Affiliated Hospital of Chongqing Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

FEDN-MDD: 53 patients with MDD who had a first episode and had not been treated with antidepressants TRD: 53 patients who had been on medication for at least 6 weeks or more and were not responding to antidepressant therapy HC: 56 healthy subjects

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
TRD; age 12-18 years; Meet the diagnostic criteria for MDD according to the DSM-5; HAMD-17 score > 13; 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%)	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; Other Names: HAMA
FEDN-MDD; 1. age 12-18 years 2. Meet the diagnostic criteria for MDD according to the DSM-5 2. First-episode and drug-naive 4. HAMD-17 score > 17	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; Other Names: HAMA
HC; age 12-18 years; HAMD-17 score < 7; HCs without a personal history of a mental illness or family history in a first-degree relative	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; Other Names: HAMA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
17 items Hamilton Depression Scale	The Hamilton Depression Scale assesses the level of depressive symptoms in patients	baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hamilton Anxiety Scale	The Hamilton Anxiety Scale assesses the level of anxiety symptoms in patients	baseline

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Chongqing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Actual): October 25, 2021
• Study Completion (Actual): December 20, 2023

Study Registration Dates

• First Submitted: March 20, 2024
• First Submitted That Met QC Criteria: March 20, 2024
• First Posted (Actual): March 26, 2024

Study Record Updates

• Last Update Posted (Actual): March 26, 2024
• Last Update Submitted That Met QC Criteria: March 20, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: treatment-resistant depression; metabolomic; adolescent MDD
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mood Disorders; Depression; Depressive Disorder; Problem Behavior; Mental Disorders; Depressive Disorder, Major; Metabolic Diseases
• Other Study ID Numbers: 1stChongqingMU-TRD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes