Non-Coding RNA Gene Expression in Psychiatric Disorders (PsiRNA26)

June 10, 2026 updated by: Carmen Concerto

Gene Expression Analysis of Non-coding RNAs in Psychiatric Disorders

This study aims to investigate whether certain non-coding RNAs, which are molecules involved in the regulation of gene activity, are altered in people with psychiatric disorders such as schizophrenia, bipolar disorder, major depression, panic disorder and obsessive-compulsive disorder. Researchers will compare the levels of these molecules in patients who have never received psychiatric medication or who have been free from treatment for at least six months with those found 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 real-time PCR (RT-PCR), a laboratory technique that analyzes gene expression. The study does not assign specific treatments, and all therapies will be prescribed according to standard clinical practice.

The main question the study is trying to answer is whether changes in non-coding RNA expression may serve as biological markers for psychiatric disorders and whether these markers may help monitor the effects of treatment over time. The findings may improve understanding of the biological mechanisms involved in major psychiatric illnesses and support the future development of more accurate diagnostic and therapeutic tools.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
64

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Italy
    • Sicily
      • Catania, Sicily, Italy, 95123
        • Psychiatry Unit, Via Santa Sofia 78
        • Contact:
        • Sub-Investigator:
          • Dr Fabrizio Bella, MD
        • Sub-Investigator:
          • Professor Antonino Petralia, PhD, MD
        • Sub-Investigator:
          • Professor Carmen Concerto, PhD, MD
        • Sub-Investigator:
          • Dr Ludovico Mineo, PhD, MD
        • Sub-Investigator:
          • Dr Lucia Basile, MD
        • Sub-Investigator:
          • Professor Cinzia Santa Di Pietro, PhD
      • Enna, Sicily, Italy, 94100
        • Psychiatry Unit, Contrada Ferrante SNC
        • Contact:
      • Messina, Sicily, Italy, 98125
        • Cellular and Molecular Biology Laboratory, Tower of Biological Laboratories, 5th Floor Via Consolare Valeria 1
        • Contact:
          • Professor Angela D'Ascola, PhD
          • Phone Number: +39 090 221 3389
          • Email: adascola@unime.it
        • Sub-Investigator:
          • Professor Michele Scuruchi, PhD
        • Sub-Investigator:
          • Professor Salvatore Campo, PhD
        • Sub-Investigator:
          • Professor Giuseppe Maurizio Campo, PhD
        • Sub-Investigator:
          • Dr Angela Avenoso, PhD
      • Messina, Sicily, Italy, 98125
        • Psychiatry Unit, Via Consolare Valeria 1
        • Contact:
      • Palermo, Sicily, Italy, 90127
        • Psychiatry Unit, Via del Vespro 129
        • Contact:
        • Sub-Investigator:
          • Dr Giovanna Marrazzo, PhD, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Control Group
Healthy volunteers
Genetic: Real-time Polymerase Chain Reaction
Gene expression analisys of nc-RNAs
Depression T0
Drug naive/drug-free Patients affected from MDD
Genetic: Real-time Polymerase Chain Reaction
Gene expression analisys of nc-RNAs
Depression T1
Patients affected from MDD after six months of treatment assumption
Genetic: Real-time Polymerase Chain Reaction
Gene expression analisys of nc-RNAs
Schizophrenia T0
Drug naive/drug-free Patients affected from Schizophrenia
Genetic: Real-time Polymerase Chain Reaction
Gene expression analisys of nc-RNAs
Schizophrenia T1
Patients affected from Schizophrenia after six months of treatment assumption
Genetic: Real-time Polymerase Chain Reaction
Gene expression analisys of nc-RNAs
Obsessive-Compulsive Disorder T0
Drug naive/drug-free Patients affected from Obsessive-Compulsive Disorder
Genetic: Real-time Polymerase Chain Reaction
Gene expression analisys of nc-RNAs
Obsessive-Compulsive Disorder T1
Patients affected from Obsessive-Compulsive Disorder after six months of treatment assumption
Genetic: Real-time Polymerase Chain Reaction
Gene expression analisys of nc-RNAs
Panic Disorder T0
Drug naive/drug-free Patients affected from Panic Disorder
Genetic: Real-time Polymerase Chain Reaction
Gene expression analisys of nc-RNAs
Panic Disorder T1
Patients affected from Panic Disorder after six months of treatment assumption
Genetic: Real-time Polymerase Chain Reaction
Gene expression analisys of nc-RNAs
Bipolar Disorder T0
Drug naive/drug-free Patients affected from Bipolar Disorder
Genetic: Real-time Polymerase Chain Reaction
Gene expression analisys of nc-RNAs
Bipolar Disorder T1
Patients affected from Bipolar Disorder after six months of treatment assumption
Genetic: Real-time Polymerase Chain Reaction
Gene expression analisys of nc-RNAs

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Differential Expression of Selected Non-Coding RNAs in Psychiatric Disorders
Time Frame: 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-PCR) and quantified through the 2^-ΔΔCt method.
Baseline (T0)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in Non-Coding RNA Expression After Pharmacological Treatment
Time Frame: Baseline (T0) and 5 months (T1)
Evaluation of changes in expression levels of circulating non-coding RNAs in psychiatric patients after at least 5 months of standard pharmacological treatment, comparing baseline (T0) and follow-up (T1) samples through RT-PCR analysis.
Baseline (T0) and 5 months (T1)
Differences in ncRNA Expression Between Psychiatric Patients and Healthy Controls
Time Frame: Baseline (T0)
Comparison of expression levels of ncRNAs involved in synaptogenesis, synaptic plasticity, glial activation, and stress-response pathways between psychiatric patients at baseline and healthy control subjects.
Baseline (T0)
Differences in ncRNA Expression Between Manic and Depressive Episodes in Bipolar Disorder
Time Frame: Baseline (T0)
Evaluation of differential expression of selected ncRNAs in patients with Bipolar Disorder during manic episodes compared with depressive episodes at baseline assessment.
Baseline (T0)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Carmen Concerto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 10, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 10, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 16, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 10/2026/CL-PAR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

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