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

18 juni 2026 bijgewerkt door: Carmen Concerto

Gene Expression Analysis of Non-coding RNAs in Psychiatric Disorders

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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

This is a multicenter, prospective, observational case-control study designed to evaluate the expression of selected non-coding RNAs in psychiatric disorders. The study will include adult drug-naïve or drug-free patients diagnosed with Bipolar Disorder type I or II, Panic Disorder, Major Depressive Disorder, Obsessive-Compulsive Disorder or Schizophrenia, as well as healthy volunteers recruited from transfusion services.

Patients will be assessed at baseline (T0) and again after at least five months of pharmacological treatment (T1). Healthy controls will be assessed at baseline only. No treatments will be assigned for the purposes of the study. All pharmacological therapies will be prescribed according to routine clinical practice.

Peripheral blood serum samples will be collected from patients and healthy controls. For patients, residual peripheral venous blood collected during routine laboratory investigations will be used for study purposes. Serum samples will be centrifuged, stored at -80 °C, and subsequently transferred on dry ice to the Cellular and Molecular Biology Laboratories of the University of Messina.

Total RNA will be extracted from serum samples and reverse-transcribed into cDNA. Expression levels of selected miRNAs and lncRNAs will be analyzed using RT-qPCR. Relative expression levels will be quantified using the 2^-ΔΔCt method.

The study aims to identify possible ncRNA expression abnormalities in major psychiatric disorders, evaluate treatment-related changes over time, and explore the potential role of ncRNAs as biomarkers for diagnosis and treatment monitoring.

Studietype

Observationeel

Inschrijving (Geschat)

384

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen

Accepteert gezonde vrijwilligers

Ja

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
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).
Genetisch: Reverse Transcription Quantitative Polymerase Chain Reaction
Gene expression analysis of selected non-coding RNAs using reverse transcription quantitative polymerase chain reaction (RT-qPCR).
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).
Genetisch: Reverse Transcription Quantitative Polymerase Chain Reaction
Gene expression analysis of selected non-coding RNAs using reverse transcription quantitative polymerase chain reaction (RT-qPCR).
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).
Genetisch: Reverse Transcription Quantitative Polymerase Chain Reaction
Gene expression analysis of selected non-coding RNAs using reverse transcription quantitative polymerase chain reaction (RT-qPCR).
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).
Genetisch: Reverse Transcription Quantitative Polymerase Chain Reaction
Gene expression analysis of selected non-coding RNAs using reverse transcription quantitative polymerase chain reaction (RT-qPCR).
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).
Genetisch: Reverse Transcription Quantitative Polymerase Chain Reaction
Gene expression analysis of selected non-coding RNAs using reverse transcription quantitative polymerase chain reaction (RT-qPCR).
Healthy Control Cohort
Healthy volunteers without current psychiatric disorders or psychotropic medication use, assessed at baseline only.
Genetisch: Reverse Transcription Quantitative Polymerase Chain Reaction
Gene expression analysis of selected non-coding RNAs using reverse transcription quantitative polymerase chain reaction (RT-qPCR).

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Differential Expression of Selected Non-Coding RNAs in Psychiatric Disorders
Tijdsspanne: 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.
Baseline (T0)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Changes in Non-Coding RNA Expression After Pharmacological Treatment
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Carmen Concerto

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 september 2026

Primaire voltooiing (Geschat)

1 september 2028

Studie voltooiing (Geschat)

1 september 2028

Studieregistratiedata

Eerst ingediend

10 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

10 juni 2026

Eerst geplaatst (Werkelijk)

16 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

23 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

18 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 10/2026/CL-PAR

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

Individual participant data (IPD) will not be shared.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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