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.
研究概览
地位
详细说明
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.
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名：Professor Maria Salvina Signorelli, PhD, MD
- 电话号码：+39 095 3782791
- 邮箱：maria.signorelli@unict.it
学习地点
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Sicily
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Catania、Sicily、意大利、95123
- Psychiatry Unit, Via Santa Sofia 78
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接触：
- Professor Maria Salvina Signorelli, PhD, MD
- 电话号码：+39 095 3782791
- 邮箱：maria.signorelli@unict.it
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副研究员：
- Dr Fabrizio Bella, MD
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副研究员：
- Professor Antonino Petralia, PhD, MD
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副研究员：
- Professor Carmen Concerto, PhD, MD
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副研究员：
- Dr Ludovico Mineo, PhD, MD
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副研究员：
- Dr Lucia Basile, MD
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副研究员：
- Professor Cinzia Santa Di Pietro, PhD
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Enna、Sicily、意大利、94100
- Psychiatry Unit, Contrada Ferrante SNC
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接触：
- Professor Antonino Messina, PhD, MD
- 电话号码：+39 0935 516044
- 邮箱：antonino.messina2@unikore.it
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Messina、Sicily、意大利、98125
- Cellular and Molecular Biology Laboratory, Tower of Biological Laboratories, 5th Floor Via Consolare Valeria 1
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接触：
- Professor Angela D'Ascola, PhD
- 电话号码：+39 090 221 3389
- 邮箱：adascola@unime.it
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副研究员：
- Professor Michele Scuruchi, PhD
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副研究员：
- Professor Salvatore Campo, PhD
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副研究员：
- Professor Giuseppe Maurizio Campo, PhD
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副研究员：
- Dr Angela Avenoso, PhD
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Messina、Sicily、意大利、98125
- Psychiatry Unit, Via Consolare Valeria 1
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接触：
- Professor Maria Rosaria Anna Muscatello, PhD, MD
- 电话号码：+39 090 2217384
- 邮箱：maria.muscatello@unime.it
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Palermo、Sicily、意大利、90127
- Psychiatry Unit, Via del Vespro 129
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接触：
- Professor Diego Quattrone, PhD, MD
- 电话号码：+39 091 238 93011
- 邮箱：diego.quattrone@unipa.it
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副研究员：
- Dr Giovanna Marrazzo, PhD, MD
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参与标准
资格标准
适合学习的年龄
- 成人
接受健康志愿者
取样方法
研究人群
描述
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.
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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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).
|
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).
|
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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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Differential Expression of Selected Non-Coding RNAs in Psychiatric Disorders
大体时间：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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Changes in Non-Coding RNA Expression After Pharmacological Treatment
大体时间：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
大体时间：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
大体时间：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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合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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