Non-Coding RNAs Gene Expression in Psychiatric Disorders

NCT07649993 | Not Yet Recruiting DMC

• 1 other identifier: 10/2026/CL-PAR
• Study Type: observational
• Target: 384
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Schizophrenia Disorders; Major Depression; Bipolar Affective Disorders; Obsessive Compulsive Disorder (OCD); Anxiety Disorder (Panic Disorder or GAD)

Outcome Measures

Primary Outcomes (1)

• Differential Expression of Selected Non-Coding RNAs in Psychiatric Disorders

  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.

  Baseline (T0)

Secondary Outcomes (3)

• Changes in Non-Coding RNA Expression After Pharmacological Treatment

  Baseline (T0) and 5 months (T1)

• Differences in ncRNA Expression Between Psychiatric Patients and Healthy Controls

  Baseline (T0)

• Differences in ncRNA Expression Between Manic and Depressive Episodes in Bipolar Disorder

  Baseline (T0)

Study Arms (6)

Major Depressive Disorder Cohort

Drug-naïve or drug-free patients diagnosed with Major Depressive Disorder, assessed at baseline (T0) and after at least five months of standard pharmacological treatment (T1).

Genetic: Reverse Transcription Quantitative Polymerase Chain Reaction

Schizophrenia Cohort

Drug-naïve or drug-free patients diagnosed with Schizophrenia, assessed at baseline (T0) and after at least five months of standard pharmacological treatment (T1).

Genetic: Reverse Transcription Quantitative Polymerase Chain Reaction

Obsessive-Compulsive Disorder Cohort

Drug-naïve or drug-free patients diagnosed with Obsessive-Compulsive Disorder, assessed at baseline (T0) and after at least five months of standard pharmacological treatment (T1).

Genetic: Reverse Transcription Quantitative Polymerase Chain Reaction

Panic Disorder Cohort

Drug-naïve or drug-free patients diagnosed with Panic Disorder, assessed at baseline (T0) and after at least five months of standard pharmacological treatment (T1).

Genetic: Reverse Transcription Quantitative Polymerase Chain Reaction

Bipolar Disorder Cohort

Drug-naïve or drug-free patients diagnosed with Bipolar Disorder type I or II, assessed at baseline (T0) and after at least five months of standard pharmacological treatment (T1).

Genetic: Reverse Transcription Quantitative Polymerase Chain Reaction

Healthy Control Cohort

Healthy volunteers without current psychiatric disorders or psychotropic medication use, assessed at baseline only.

Genetic: Reverse Transcription Quantitative Polymerase Chain Reaction

Interventions

Reverse Transcription Quantitative Polymerase Chain Reaction GENETIC

Gene expression analysis of selected non-coding RNAs using reverse transcription quantitative polymerase chain reaction (RT-qPCR).

Bipolar Disorder Cohort; Healthy Control Cohort; Major Depressive Disorder Cohort; Obsessive-Compulsive Disorder Cohort; Panic Disorder Cohort; Schizophrenia Cohort

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Carmen Concerto: lead

Study Sites (5)

Psychiatry Unit, Via Santa Sofia 78

Catania, Sicily, 95123, Italy

Location

Psychiatry Unit, Contrada Ferrante SNC

Enna, Sicily, 94100, Italy

Location

Cellular and Molecular Biology Laboratory, Tower of Biological Laboratories, 5th Floor Via Consolare Valeria 1

Messina, Sicily, 98125, Italy

Location

Psychiatry Unit, Via Consolare Valeria 1

Messina, Sicily, 98125, Italy

Location

Psychiatry Unit, Via del Vespro 129

Palermo, Sicily, 90127, Italy

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Peripheral blood serum samples will be collected from patients and healthy controls. Serum will be separated by centrifugation and stored at -80 °C before transfer on dry ice to the Cellular and Molecular Biology Laboratories of the University of Messina for RNA extraction and ncRNA expression analysis.

MeSH Terms

Conditions

Schizophrenia; Depressive Disorder, Major; Obsessive-Compulsive Disorder; Anxiety Disorders; Panic Disorder; Generalized Anxiety Disorder

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Depressive Disorder; Mood Disorders

Central Study Contacts

Professor Maria Salvina Signorelli, PhD, MD

CONTACT

+39 095 3782791; maria.signorelli@unict.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: June 10, 2026
• First Posted: June 16, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: June 23, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (5)