Non-Coding RNAs Gene Expression in Psychiatric Disorders

NCT07649993 · tracked via the Priya Life Science Italy tracker

Sponsor

Carmen Concerto

Phase

Observational

Started

2026-09-01

Last updated

2026-06-23

Condition(s) studied

Schizophrenia DisordersMajor DepressionBipolar Affective DisordersObsessive Compulsive Disorder (OCD)Anxiety Disorder (Panic Disorder or GAD)

Investigational drug(s) / intervention(s)

Reverse Transcription Quantitative Polymerase Chain Reaction

Reverse Transcription Quantitative Polymerase Chain Reaction: Gene expression analysis of selected non-coding RNAs using reverse transcription quantitative polymerase chain reaction (RT-qPCR).

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

55 Years

Healthy volunteers

Accepted

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.

Primary outcome measure(s)

Differential Expression of Selected Non-Coding RNAs in Psychiatric Disorders — Baseline (T0)
Assessment of relative expression levels of a predefined panel of circulating non-coding RNAs (miRNAs and lncRNAs) in peripheral blood serum of drug-naive/drug-free psychiatric patients compared with healthy controls, using real-time PCR (RT-qPCR) and quantified through the 2\^-ΔΔCt method.

Trial sites (5)

Facility	City	Region
Psychiatry Unit, Via Santa Sofia 78	Catania	Sicily
Psychiatry Unit, Contrada Ferrante SNC	Enna	Sicily
Cellular and Molecular Biology Laboratory, Tower of Biological Laboratories, 5th Floor Via Consolare Valeria 1	Messina	Sicily
Psychiatry Unit, Via Consolare Valeria 1	Messina	Sicily
Psychiatry Unit, Via del Vespro 129	Palermo	Sicily

Other trials for the same condition

Chemokine Receptors on CD8+ T Cells in Patients With Bipolar Disorder Starting soon

An Integrated Neurophysiological Approach Toward the Early Detection of Psychiatric Disorders Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07649993 on ClinicalTrials.gov ↗ ← All trials in Italy