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

NCT06331572 | Completed DMC

• 1 other identifier: 1stChongqingMU-TRD
• Study Type: observational
• Target: 162
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Psychiatric Disorder; Major Depressive Disorder; Metabolic Disorder

Keywords

adolescent MDD; treatment-resistant depression; metabolomic

Outcome Measures

Primary Outcomes (1)

• 17 items Hamilton Depression Scale

  The Hamilton Depression Scale assesses the level of depressive symptoms in patients

  baseline

Secondary Outcomes (1)

• Hamilton Anxiety Scale

  baseline

Study Arms (3)

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%)

Diagnostic Test: 17-HAMD

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

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

Diagnostic Test: 17-HAMD

Interventions

17-HAMD DIAGNOSTIC_TEST

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

Also known as: HAMA

FEDN-MDD; HC; TRD

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

• FEDN-MDD：
• Age 12-18 years
• Meet the diagnostic criteria for MDD according to the DSM-5
• First-episode and drug-naive
• HAMD-17 score \> 17
• 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%)
• 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

You may not qualify if:

• FEDN-MDD、TRD：
• the presence or past history of severe medical, neurological or psychiatric disorders (other than MDD in patients)
• substance abuse, head trauma, or loss of consciousness
• Chronic physical diseases that significantly affect peripheral metabolism or neurological function
• Pregnant and lactating women
• HC:
• the presence or past history of severe medical, neurological or psychiatric disorders
• substance abuse, head trauma, or loss of consciousness
• Chronic physical diseases that significantly affect peripheral metabolism or neurological function
• Pregnant and lactating women

Sponsors & Collaborators

• First Affiliated Hospital of Chongqing Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Province, 400000, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Staging of diseases in the inclusion exclusion criteria refer to previous studies

MeSH Terms

Conditions

Mental Disorders; Depressive Disorder, Major; Metabolic Diseases; Depressive Disorder, Treatment-Resistant

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: March 20, 2024
• First Posted: March 26, 2024
• Study Start: August 1, 2021
• Primary Completion: October 25, 2021
• Study Completion: December 20, 2023
• Last Updated: March 26, 2024

Record last verified: 2024-03

Locations

CN (1)