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

10. juni 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Observationel

Tilmelding (Anslået)

64

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ja

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Kontrolgruppe
Sunde frivillige
Genetisk: Real-time Polymerase Chain Reaction
Gene expression analisys of nc-RNAs
Depression T0
Drug naive/drug-free Patients affected from MDD
Genetisk: Real-time Polymerase Chain Reaction
Gene expression analisys of nc-RNAs
Depression T1
Patients affected from MDD after six months of treatment assumption
Genetisk: Real-time Polymerase Chain Reaction
Gene expression analisys of nc-RNAs
Schizophrenia T0
Drug naive/drug-free Patients affected from Schizophrenia
Genetisk: Real-time Polymerase Chain Reaction
Gene expression analisys of nc-RNAs
Schizophrenia T1
Patients affected from Schizophrenia after six months of treatment assumption
Genetisk: 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
Genetisk: 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
Genetisk: Real-time Polymerase Chain Reaction
Gene expression analisys of nc-RNAs
Panic Disorder T0
Drug naive/drug-free Patients affected from Panic Disorder
Genetisk: 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
Genetisk: Real-time Polymerase Chain Reaction
Gene expression analisys of nc-RNAs
Bipolar Disorder T0
Drug naive/drug-free Patients affected from Bipolar Disorder
Genetisk: 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
Genetisk: Real-time Polymerase Chain Reaction
Gene expression analisys of nc-RNAs

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Differential Expression of Selected Non-Coding RNAs in Psychiatric Disorders
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Changes in Non-Coding RNA Expression After Pharmacological Treatment
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Carmen Concerto

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. september 2026

Primær færdiggørelse (Anslået)

1. september 2028

Studieafslutning (Anslået)

1. september 2028

Datoer for studieregistrering

Først indsendt

10. juni 2026

Først indsendt, der opfyldte QC-kriterier

10. juni 2026

Først opslået (Faktiske)

16. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 10/2026/CL-PAR

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

Individual participant data (IPD) will not be shared.

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