NCT07649993Not yet recruiting
Non-Coding RNAs Gene Expression in Psychiatric Disorders
Gene Expression Analysis of Non-coding RNAs in Psychiatric Disorders
Source: ClinicalTrials.gov · Last updated 23 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 384 (estimated)
- First submitted
- 10 Jun 2026
- Start date
- Sept 2026
- Primary completion date
- Sept 2028
- Lead sponsor
- Carmen Concerto
- Diseases
- Schizophrenia, Depression, Bipolar disorder
- NCT number
- NCT07649993
What you commit to
- Study type: Observational
- Planned participants: 384
- From Sept 2026 to the primary completion date, Sept 2028
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current immunosuppressive, antibiotic, or hormone replacement therapy;
- Active infectious diseases or infections resolved less than 3 weeks before enrollment;
- Current psychopharmacological treatment or discontinuation of psychopharmacological therapy less than 6 months before enrollment.
Other illness
- Relevant medical comorbidities, including autoimmune or internal medicine disorders;
- Relevant psychiatric comorbidities;
Who the study is looking for
- 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.
- 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.
Age in the registry: 18 years to 55 years · Sex: All · Accepts healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Psychiatry Unit, Via Santa Sofia 78 Coordinator of this site? Confirm its status | Catania | Italy | Unknown status |
| Psychiatry Unit, Contrada Ferrante SNC Coordinator of this site? Confirm its status | Enna | Italy | Unknown status |
| Cellular and Molecular Biology Laboratory, Tower of Biological Laboratories, 5th Floor Via Consolare Valeria 1 Coordinator of this site? Confirm its status | Messina | Italy | Unknown status |
| Psychiatry Unit, Via Consolare Valeria 1 Coordinator of this site? Confirm its status | Messina | Italy | Unknown status |
| Psychiatry Unit, Via del Vespro 129 Coordinator of this site? Confirm its status | Palermo | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.