Non-Coding RNAs Gene Expression in Psychiatric Disorders (PsiRNA26)
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Professor Maria Salvina Signorelli, PhD, MD
- Número de teléfono: +39 095 3782791
- Correo electrónico: maria.signorelli@unict.it
Ubicaciones de estudio
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Sicily
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Catania, Sicily, Italia, 95123
- Psychiatry Unit, Via Santa Sofia 78
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Contacto:
- Professor Maria Salvina Signorelli, PhD, MD
- Número de teléfono: +39 095 3782791
- Correo electrónico: maria.signorelli@unict.it
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Sub-Investigador:
- Dr Fabrizio Bella, MD
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Sub-Investigador:
- Professor Antonino Petralia, PhD, MD
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Sub-Investigador:
- Professor Carmen Concerto, PhD, MD
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Sub-Investigador:
- Dr Ludovico Mineo, PhD, MD
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Sub-Investigador:
- Dr Lucia Basile, MD
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Sub-Investigador:
- Professor Cinzia Santa Di Pietro, PhD
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Enna, Sicily, Italia, 94100
- Psychiatry Unit, Contrada Ferrante SNC
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Contacto:
- Professor Antonino Messina, PhD, MD
- Número de teléfono: +39 0935 516044
- Correo electrónico: antonino.messina2@unikore.it
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Messina, Sicily, Italia, 98125
- Cellular and Molecular Biology Laboratory, Tower of Biological Laboratories, 5th Floor Via Consolare Valeria 1
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Contacto:
- Professor Angela D'Ascola, PhD
- Número de teléfono: +39 090 221 3389
- Correo electrónico: adascola@unime.it
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Sub-Investigador:
- Professor Michele Scuruchi, PhD
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Sub-Investigador:
- Professor Salvatore Campo, PhD
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Sub-Investigador:
- Professor Giuseppe Maurizio Campo, PhD
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Sub-Investigador:
- Dr Angela Avenoso, PhD
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Messina, Sicily, Italia, 98125
- Psychiatry Unit, Via Consolare Valeria 1
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Contacto:
- Professor Maria Rosaria Anna Muscatello, PhD, MD
- Número de teléfono: +39 090 2217384
- Correo electrónico: maria.muscatello@unime.it
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Palermo, Sicily, Italia, 90127
- Psychiatry Unit, Via del Vespro 129
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Contacto:
- Professor Diego Quattrone, PhD, MD
- Número de teléfono: +39 091 238 93011
- Correo electrónico: diego.quattrone@unipa.it
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Sub-Investigador:
- Dr Giovanna Marrazzo, PhD, MD
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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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).
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Gene expression analysis of selected non-coding RNAs using reverse transcription quantitative polymerase chain reaction (RT-qPCR).
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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).
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Gene expression analysis of selected non-coding RNAs using reverse transcription quantitative polymerase chain reaction (RT-qPCR).
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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).
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Gene expression analysis of selected non-coding RNAs using reverse transcription quantitative polymerase chain reaction (RT-qPCR).
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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).
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Gene expression analysis of selected non-coding RNAs using reverse transcription quantitative polymerase chain reaction (RT-qPCR).
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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).
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Gene expression analysis of selected non-coding RNAs using reverse transcription quantitative polymerase chain reaction (RT-qPCR).
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Healthy Control Cohort
Healthy volunteers without current psychiatric disorders or psychotropic medication use, assessed at baseline only.
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Gene expression analysis of selected non-coding RNAs using reverse transcription quantitative polymerase chain reaction (RT-qPCR).
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Differential Expression of Selected Non-Coding RNAs in Psychiatric Disorders
Periodo de tiempo: Baseline (T0)
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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.
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Baseline (T0)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Changes in Non-Coding RNA Expression After Pharmacological Treatment
Periodo de tiempo: Baseline (T0) and 5 months (T1)
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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.
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Baseline (T0) and 5 months (T1)
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Differences in ncRNA Expression Between Psychiatric Patients and Healthy Controls
Periodo de tiempo: Baseline (T0)
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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.
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Baseline (T0)
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Differences in ncRNA Expression Between Manic and Depressive Episodes in Bipolar Disorder
Periodo de tiempo: Baseline (T0)
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Evaluation of differential expression of selected ncRNAs in patients with Bipolar Disorder during manic episodes compared with depressive episodes at baseline assessment.
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Baseline (T0)
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Espectro de esquizofrenia y otros trastornos psicóticos
- Desordenes mentales
- Trastornos del estado de ánimo
- Desorden depresivo
- Esquizofrenia
- Desórdenes de ansiedad
- Trastorno Depresivo Mayor
- Desorden obsesivo compulsivo
- Trastorno de pánico
- Trastorno de ansiedad generalizada
- Técnicas de investigación
- Técnicas genéticas
- Reacción en cadena de la polimerasa
- Técnicas de amplificación de ácido nucleico
- Reacción en cadena de la polimerasa en tiempo real
Otros números de identificación del estudio
- 10/2026/CL-PAR
Plan de datos de participantes individuales (IPD)
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Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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