Psychiatric DisorderNCT06331572
Exploring Blood Plasma Metabolomics: Unraveling the Metabolic Landscape in Treatment-Resistant Adolescent Depression
An observational study of Psychiatric Disorder and Major Depressive Disorder, run by First Affiliated Hospital of Chongqing Medical University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychiatric Disorder, Major Depressive Disorder, Metabolic Disorder
- What is being tested?
- 17-HAMD
- How many people
- 162 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2021to 20 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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
Who may be able to join
- 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:
Show all 14Show fewer
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Province, 400000
About this study
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.
- Being tested
- 17-HAMD
- Keywords
- adolescent MDD, treatment-resistant depression, metabolomic
- Medical subject headings
- Mental Disorders, Depressive Disorder, Major, Metabolic Diseases, Depressive Disorder, Treatment-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
17-HAMDDiagnostic test
Also called HAMA
Patients were interviewed in a semi-structured manner and assessed using the 17-item Hamilton Depression Scale and the Hamilton Anxiety Scale
| Study group | Role | What they receive |
|---|---|---|
| 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%) Receives: 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 Receives: 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 Receives: Diagnostic Test: 17-HAMD |
What is being measured
The primary outcome is the main question the study is designed to answer.
17 items Hamilton Depression Scale
The Hamilton Depression Scale assesses the level of depressive symptoms in patients
Measured: baseline
Secondary outcomes (1)
Hamilton Anxiety Scale
The Hamilton Anxiety Scale assesses the level of anxiety symptoms in patients
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start1 Aug 2021
- Primary completion25 Oct 2021
- Study completion20 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Psychiatric DisorderStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Chongqing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xinyu Zhou, First Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06331572
- Sponsor's protocol ID
- 1stChongqingMU-TRD
- Status last verified
- Mar 2024
- First submitted
- 20 Mar 2024
- Last updated
- 26 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gan X, Li X, Cai Y, Yin B, Pan Q, Teng T, He Y, Tang H, Wang T, Li J, Zhu Z, Zhou X, Li J. Metabolic features of adolescent major depressive disorder: A comparative study between treatment-resistant depression and first-episode drug-naive depression. Psychoneuroendocrinology. 2024 Sep;167:107086. doi: 10.1016/j.psyneuen.2024.107086. Epub 2024 May 22.
PubMed 38824765
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Blood Plasma Metabolomics: Unraveling the Metabolic Landscape in Treatment-Resistant Adolescent Depression
- ClinicalTrials.gov ID
- NCT06331572
- Acronym / sponsor ID
- 1stChongqingMU-TRD
- Keywords
- adolescent MDD, treatment-resistant depression, metabolomic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- First Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 25 Oct 2021 (actual)
- Study completion
- 20 Dec 2023 (actual)
- First posted
- 26 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TRD | – | Diagnostic Test: 17-HAMD1. 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%) |
| FEDN-MDD | – | Diagnostic Test: 17-HAMD1. 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 |
| HC | – | Diagnostic Test: 17-HAMD1. 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 |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 17-HAMDAlso: HAMAPatients were interviewed in a semi-structured manner and assessed using the 17-item Hamilton Depression Scale and the Hamilton Anxiety Scale | Diagnostic test | FEDN-MDD, HC, TRD |
Primary outcome
17 items Hamilton Depression Scale
Time frame: baseline
The Hamilton Depression Scale assesses the level of depressive symptoms in patients
1 secondary outcome
Hamilton Anxiety Scale
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
- Derived from this study: PubMed 38824765Gan X, Li X, Cai Y, Yin B, Pan Q, Teng T, He Y, Tang H, Wang T, Li J, Zhu Z, Zhou X, Li J. Metabolic features of adolescent major depressive disorder: A comparative study between treatment-resistant depression and first-episode drug-naive depression. Psychoneuroendocrinology. 2024 Sep;167:107086. doi: 10.1016/j.psyneuen.2024.107086. Epub 2024 May 22.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychiatric Disorder and Major Depressive Disorder, run by First Affiliated Hospital of Chongqing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
17 items Hamilton Depression Scale (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06331572, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2024.