Major Depressive DisorderNCT05585047
Treatment Response Biomarkers in MDD
An observational study of Major Depressive Disorder, run by Zhang Yan at 1 site in China.
Trial summary
This experiment intends to explore the differences among various types of depression, as well as the differences between healthy subjects and depressed patients, and find possible biological markers from the severity of symptoms, social function and cognitive function of depressed patients, combined with EEG… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder
- How many people
- 480 participants
- Where
- 1 siteChina
- Study dates
- 10 Jun 2021to 31 Aug 2026
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Samples are taken from depressed patients in outpatient and inpatient departments of hospitals and recruited health care workers. 480 subjects are expected to be collected and divided into two groups, 180 healthy subjects and 300 experimental subjects.
Who may be able to join
- The subject is an outpatient/inpatient (but the subject who participated in the experimental treatment does not need to be hospitalized), and passed M.I.N.I. interview confirmed that the subjects met DSM-5 diagnostic criteria of current or past major depressive disorder.
- Age 18-60 years old, regardless of gender;
- Right-handed;
- Junior high school education or above, capable of completing informed consent and cognitive test;
- During the follow-up period, the subjects can take antidepressant treatment according to the doctor's advice of outpatient or resident.
- -
Who cannot join
- Patients with psychotic symptoms;
- M.I.N.I. was diagnosed as schizophrenia, schizophrenic affective disorder, schizophrenia-like disorder, Paranoia or current mental symptoms, post-traumatic stress disorder (currently or within the past year) or dysthymia;
- with brain organic and serious physical diseases (such as thyroid disease, lupus erythematosus, diabetes, lung, liver and kidney) damage, infection, major trauma, etc.) exclude intracranial implants;
- Clinically significant sensory disturbance that can't be corrected (for example, hearing impairment makes conversation impossible);
- Pregnant and lactating women; -
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Central South University
Changsha, Hunan, 410001
yan zhan, doctor, 13807315182, yan.zhang@csu.edu.cn
yumeng ju, doctor, 19908463800, yumeng.ju@csu.edu.cn
About this study
Official title: Prospective Biomarkers for Treatment Response in Major Depressive Disorder
This experiment intends to explore the differences among various types of depression, as well as the differences between healthy subjects and depressed patients, and find possible biological markers from the severity of symptoms, social function and cognitive function of depressed patients, combined with EEG characteristics, biological test indicators (blood, faeces, hair, etc.) and functional magnetic resonance imaging data.
To explore the changes in clinical symptoms, cognitive and social functions, and biological indicators of various types of patients before and after treatment, to provide references for the prognosis of various types, and to predict the future development of the disease according to the baseline indicators of patients; According to the above aspects, this experiment can follow up the patients with depression, track their disease development, and study the potential biological changes in the early stage of the disease, which has the potential to reveal the pathogenesis and provide guidance for the early diagnosis and intervention of depression.
Read the detailed description
More specifically, the goals of this study are to 1) explore the potential biomarkers for Major Depressive Disorder by comparing MDD patients and healthy controls; 2) investigate the biochemical indicators for subtypes of MDD through long-term cohort follow-up studies; 3) investigate the differences and similarities among different types of MDD patients in terms of cognitive functions, biological tests, as well as neuroimaging data; 4) evaluate and analyze the prognosis of patients according to the baseline level, and search for the biomarkers regarding MDD treatment response to guide the clinical treatment and intervention of patients with MDD; 5) Through the long-term follow-up study, the behavioural and biochemical indicators of the patients with MDD were collected, the differences between the indicators before and after remission were examined, and the state and quality of the pathophysiological indicators of the patients with MDD were investigated.
- Conditions
- Major Depressive Disorder
- Keywords
- Treatment Response, Biomarkers
- Medical subject headings
- Depressive Disorder, Major
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hamilton Depression Rating Scale-24 item (HAMD-24)Interview-based questionnaire used to measure the severity of depression
Consists of 24 items with a score calculated. Higher scores are associated with more severe depression.
Measured: 8weeks
Secondary outcomes (5)
Change in Hamilton Depression Rating Scale-17 item (HAMD-17)Interview-based questionnaire used to measure the severity of depression.
Consists of 17 items with a score calculated. Higher scores are associated with more severe depression.
Measured: Baseline, 2weeks, 1 month, 2 months，4months，6months，1year
Change in Hamilton Anxiety Rating Scale-14 item (HAMA-14)Interview-based questionnaire used to measure the severity of anxiety.
Consists of 14 items with a score calculated. Higher scores are associated with more severe anxiety.
Measured: Baseline, 2weeks, 1 month, 2 months，4months，6months，1year
Change in DSST (Number of Correct Symbols)
Digit Symbol Substitution Test (DSST) is a cognitive test designed to assess psychomotor speed of performance requiring visual perception, spatial decision-making, and motor skills. It consists of 133 digits and requires the patient to substitute each digit with a simple symbol in a 90-second period. Each correct symbol is counted, and the total score ranges from 0 (less than normal functioning) to 133 (greater than normal functioning)." as a description of DSST.
Measured: Baseline, 2weeks, 1 month, 2 months，4months，6months，1year
Change in Generalized Anxiety Disorder-7 (GAD-7)
The GAD-7 aims to assesses the severity of anxious symptoms.
Measured: Baseline, 2weeks, 1 month, 2 months，4months，6months，1year
Change in Patient Health Questionnaire-9 (PHQ-9)
The PHQ-9 aims to assesses the severity of depression symptoms.
Measured: Baseline, 2weeks, 1 month, 2 months，4months，6months，1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2022
- Study start10 Jun 2021
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhang Yan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhang Yan, Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05585047
- Sponsor's protocol ID
- MDD202011
- Status last verified
- Oct 2022
- First submitted
- 15 Oct 2022
- Last updated
- 19 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Biomarkers for Treatment Response in Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT05585047
- Acronym / sponsor ID
- MDD202011
- Conditions
- Major Depressive Disorder
- Keywords
- Treatment Response, Biomarkers
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Zhang YanUniversity, hospital or other
- Study start
- 10 Jun 2021 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 18 Oct 2022 (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 experiment intends to explore the differences among various types of depression, as well as the differences between healthy subjects and depressed patients, and find possible biological markers from the severity of symptoms, social function and cognitive function of depressed patients, combined with EEG characteristics, biological test indicators (blood, faeces, hair, etc.) and functional magnetic resonance imaging data.
To explore the changes in clinical symptoms, cognitive and social functions, and biological indicators of various types of patients before and after treatment, to provide references for the prognosis of various types, and to predict the future development of the disease according to the baseline indicators of patients; According to the above aspects, this experiment can follow up the patients with depression, track their disease development, and study the potential biological changes in the early stage of the disease, which has the potential to reveal the pathogenesis and provide guidance for the early diagnosis and intervention of depression.
Detailed description
More specifically, the goals of this study are to 1) explore the potential biomarkers for Major Depressive Disorder by comparing MDD patients and healthy controls; 2) investigate the biochemical indicators for subtypes of MDD through long-term cohort follow-up studies; 3) investigate the differences and similarities among different types of MDD patients in terms of cognitive functions, biological tests, as well as neuroimaging data; 4) evaluate and analyze the prognosis of patients according to the baseline level, and search for the biomarkers regarding MDD treatment response to guide the clinical treatment and intervention of patients with MDD; 5) Through the long-term follow-up study, the behavioural and biochemical indicators of the patients with MDD were collected, the differences between the indicators before and after remission were examined, and the state and quality of the pathophysiological indicators of the patients with MDD were investigated.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Samples are taken from depressed patients in outpatient and inpatient departments of hospitals and recruited health care workers. 480 subjects are expected to be collected and divided into two groups, 180 healthy subjects and 300 experimental subjects.
Key inclusion criteria (6 listed)
- The subject is an outpatient/inpatient (but the subject who participated in the experimental treatment does not need to be hospitalized), and passed M.I.N.I. interview confirmed that the subjects met DSM-5 diagnostic criteria of current or past major depressive disorder.
- Age 18-60 years old, regardless of gender;
- Right-handed;
- Junior high school education or above, capable of completing informed consent and cognitive test;
- During the follow-up period, the subjects can take antidepressant treatment according to the doctor's advice of outpatient or resident.
Key exclusion criteria (5 listed)
- Patients with psychotic symptoms;
- M.I.N.I. was diagnosed as schizophrenia, schizophrenic affective disorder, schizophrenia-like disorder, Paranoia or current mental symptoms, post-traumatic stress disorder (currently or within the past year) or dysthymia;
- with brain organic and serious physical diseases (such as thyroid disease, lupus erythematosus, diabetes, lung, liver and kidney) damage, infection, major trauma, etc.) exclude intracranial implants;
- Clinically significant sensory disturbance that can't be corrected (for example, hearing impairment makes conversation impossible);
- Pregnant and lactating women; -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Hamilton Depression Rating Scale-24 item (HAMD-24)Interview-based questionnaire used to measure the severity of depression
Time frame: 8weeks
Consists of 24 items with a score calculated. Higher scores are associated with more severe depression.
5 secondary outcomes
Change in Hamilton Depression Rating Scale-17 item (HAMD-17)Interview-based questionnaire used to measure the severity of depression.
Time frame: Baseline, 2weeks, 1 month, 2 months，4months，6months，1year
Change in Hamilton Anxiety Rating Scale-14 item (HAMA-14)Interview-based questionnaire used to measure the severity of anxiety.
Time frame: Baseline, 2weeks, 1 month, 2 months，4months，6months，1year
Change in DSST (Number of Correct Symbols)
Time frame: Baseline, 2weeks, 1 month, 2 months，4months，6months，1year
Change in Generalized Anxiety Disorder-7 (GAD-7)
Time frame: Baseline, 2weeks, 1 month, 2 months，4months，6months，1year
Change in Patient Health Questionnaire-9 (PHQ-9)
Time frame: Baseline, 2weeks, 1 month, 2 months，4months，6months，1year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2022.
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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.
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 Major Depressive Disorder, run by Zhang Yan 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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 19 Oct 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact yan zhan, doctor (13807315182, yan.zhang@csu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hamilton Depression Rating Scale-24 item (HAMD-24)Interview-based questionnaire used to measure the severity of depression (time frame: 8weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Oct 2022.