Blood test clues for mental health disorders?
NCT ID NCT07649993
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study will examine whether certain RNA molecules in the blood are different in people with psychiatric disorders like schizophrenia, depression, bipolar disorder, OCD, and panic disorder. Researchers will compare these molecules in patients who are not currently on medication and in healthy volunteers. They will also check if the molecules change after about five months of standard treatment. The goal is to find biological markers that could help diagnose or monitor these conditions.
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 point toward biological markers to help diagnose or track psychiatric disorders more accurately.
- What could go wrong
- This is an observational study, not a treatment trial. It is early-stage research, and the findings may not lead to any practical tests or therapies.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 384 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 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
The study population will consist of adult psychiatric inpatients and day-hospital/day-service patients recruited from the Psychiatry Units of the University Hospitals of Catania, Messina, Palermo, and the Psychiatry Unit of Umberto I Hospital in Enna. Eligible participants will include drug-naive or drug-free subjects diagnosed with Bipolar Disorder type I or II, Major Depressive Disorder, Panic Disorder, Obsessive-Compulsive Disorder, or Schizophrenia. Healthy controls will consist of volunteer blood donors recruited from the transfusion services of the participating university hospitals.
- Ages
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18 to 55 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 (patients): * Age between 18 and 55 years; * Male sex or female sex in the mid-luteal phase of the menstrual cycle; * Clinical presentation consistent with diagnostic criteria for: * Bipolar Disorder type I or II, * Panic Disorder, * Major Depressive Disorder, * Obsessive-Compulsive Disorder, * Schizophrenia; * First diagnosis and drug-naive status, or absence of psychopharmacological treatment for at least 6 months prior to enrollment. Inclusion Criteria (Healthy Control): * Age between 18 and 55 years; * Male sex or female sex in the mid-luteal phase of the menstrual cycle; * No treatment with psychotropic medications; * Absence of clinical elements supporting a diagnosis of Bipolar Disorder, Panic Disorder, Major Depressive Disorder, Obsessive-Compulsive Disorder, Schizophrenia; * Absence of clinical or laboratory evidence of infectious or internal medicine diseases; * Absence of autoimmune diseases; * HAM-D score \< 8; * MRS score \< 11; * Y-BOCS score \< 7; * BPRS score = 18; * No significant stressful life events during the previous 6 months. Exclusion Criteria (patients): * Current immunosuppressive, antibiotic, or hormone replacement therapy; * Relevant medical comorbidities, including autoimmune or internal medicine disorders; * Active infectious diseases or infections resolved less than 3 weeks before enrollment; * Relevant psychiatric comorbidities; * Current psychopharmacological treatment or discontinuation of psychopharmacological therapy less than 6 months before enrollment.
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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
5 sites. 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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Cellular and Molecular Biology Laboratory, Tower of Biological Laboratories, 5th Floor Via Consolare Valeria 1
Messina, Sicily, 98125, Italy
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Psychiatry Unit, Contrada Ferrante SNC
Enna, Sicily, 94100, Italy
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Psychiatry Unit, Via Consolare Valeria 1
Messina, Sicily, 98125, Italy
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Psychiatry Unit, Via Santa Sofia 78
Catania, Sicily, 95123, Italy
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Psychiatry Unit, Via del Vespro 129
Palermo, Sicily, 90127, Italy
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