Non-Coding RNAs Gene Expression in Psychiatric Disorders
Italy384 participantsStarted 2026-09-01
Plain-language summary
This study aims to investigate whether specific non-coding RNAs, molecules involved in the regulation of gene expression, are altered in individuals with psychiatric disorders such as schizophrenia, bipolar disorder, major depressive disorder, panic disorder, and obsessive-compulsive disorder. Researchers will compare the expression levels of these molecules in patients who are drug-naïve or have been free from psychiatric treatment for at least six months with those observed in healthy volunteers.
The study will also evaluate whether the expression of these non-coding RNAs changes after approximately five months of standard psychiatric treatment. Blood samples collected during routine clinical care will be used to measure the expression levels of selected non-coding RNAs using reverse transcription quantitative polymerase chain reaction (RT-qPCR), a laboratory technique used to assess gene expression.
This is an observational study and does not assign specific treatments. All therapies will be prescribed according to standard clinical practice.
The main objective is to determine whether alterations in non-coding RNA expression may serve as biological markers of psychiatric disorders and whether these markers may help monitor treatment-related changes over time. The findings may contribute to a better understanding of the biological mechanisms underlying major psychiatric disorders and support the future development of more accurate diagnostic and therapeutic approaches.
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is looking at non-coding RNA expression in people with conditions like schizophrenia, major depression, bipolar disorder, OCD, and anxiety disorders — can you explain what that means in plain terms, and whether my specific diagnosis makes me a reasonable candidate to discuss with the research team once they start recruiting?
2Since this study is listed as 'not yet recruiting,' how would I find out when it opens, and is there a way to get on a notification list so we don't miss the window?
3It sounds like this is an observational or biological study measuring gene expression rather than testing a new treatment — does that mean there's no experimental drug or therapy involved, and what would actually be asked of me as a participant, like blood draws or biopsies?
4Because this trial is focused on understanding the biology of psychiatric disorders rather than treating them, would participating in any way affect or delay my current treatment plan, and should I be pursuing standard care options at the same time?
5What could the researchers potentially learn from studying non-coding RNA patterns across these different psychiatric conditions, and how might findings like that eventually benefit people with my diagnosis down the road?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Differential Expression of Selected Non-Coding RNAs in Psychiatric Disorders