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OpenTrials
Completed

NCT Number: NCT06331572

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.

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Key information

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Province, 400000, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

FEDN-MDD、TRD:

  • the presence or past history of severe medical, neurological or psychiatric disorders (other than MDD in patients)
  • anxiety comorbidity was not considered an exclusion criterion provided that MDD was the main diagnosis and the primary reason for seeking assistance
  • 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

Treatment and study plan

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

Other names: HAMA

Primary outcomes

  1. 17 items Hamilton Depression Scale

    Time frame: baseline

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

Secondary outcomes

  1. Hamilton Anxiety Scale

    Time frame: baseline

    The Hamilton Anxiety Scale assesses the level of anxiety symptoms in patients

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Chongqing Medical University

Other

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2023
First posted
Mar 26, 2024
Registry last updated
Mar 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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