Depression's biological fingerprint: a quest for objective diagnosis and personalized treatment
NCT ID NCT07735143
First seen Jul 29, 2026 · Last updated Aug 04, 2026 · Updated 3 times
Summary
This study aims to develop models that combine clinical assessments with biological data (multi-omics) to improve diagnosis of major depressive disorder and predict how patients will respond to antidepressants. Researchers will follow 150 participants aged 14-45 with depression, along with healthy controls, collecting blood samples and clinical evaluations over time. The goal is to identify reliable biomarkers that could one day guide personalized treatment decisions.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this could lead to biological tests that help diagnose depression and predict which antidepressant will work for a person.
- What could go wrong
- This is an observational study, not a treatment trial. The models may not prove accurate enough for routine use, and results may not apply to all age groups or populations.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 150 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2027
An estimate. Start dates often move.
- Expected to finish
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Feb 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
This study enrolls participants aged 14-45 years from outpatient and inpatient psychiatric settings, comprising two cohorts: participants meeting DSM-5 criteria for major depressive disorder (MDD) and demographically matched healthy controls (HCs) without current or lifetime major psychiatric disorders. MDD participants are recruited during an active depressive episode with baseline Montgomery-Åsberg Depression Rating Scale (MADRS) score ≥24 and 17-item Hamilton Depression Rating Scale (HAMD-17) score ≥18. HC participants are frequency-matched to the MDD cohort by age and sex distribution.
- Ages
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14 to 45 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: General criteria: * Participants aged 14-45 years. * Participants are able to understand the study procedures and provide written informed consent. For participants younger than 18 years, both the participant and their legal guardian must provide consent. Major Depressive Disorder (MDD) cohort: * Meet DSM-5 criteria for major depressive disorder (single or recurrent episode). * Have a baseline Montgomery-Åsberg Depression Rating Scale (MADRS) score ≥24 and 17-item Hamilton Depression Rating Scale (HAMD-17) score ≥18. Healthy Control (HC) cohort: \- Healthy participants without a current or lifetime diagnosis of major psychiatric disorders. Exclusion Criteria: For all participants: \- Severe or unstable medical conditions, pregnancy or breastfeeding, or other conditions considered unsuitable for study participation. For the MDD cohort: * Current or lifetime diagnosis of other major psychiatric disorders, including schizophrenia spectrum disorders, schizoaffective disorder, or bipolar disorder. * Substance use disorder within 12 months prior to screening. * Depression secondary to medical or neurological conditions. * Regular antidepressant treatment within 2 weeks prior to enrollment. * Electroconvulsive therapy (ECT), repetitive transcranial magnetic stimulation (rTMS), vagus nerve stimulation (VNS), or immunosuppressive therapy during the current depressive episode. * Current active suicidal plan or recent suicidal behavior considered unsuitable for participation. For the HC cohort: * Current or lifetime diagnosis of any psychiatric disorder. * Significant depressive, anxiety, manic, or psychotic symptoms. * Previous treatment with antidepressants, antipsychotics, or mood stabilizers. * Significant family history of major psychiatric disorders.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Shanghai Mental Health Center
Shanghai, 200030, China
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