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.
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Professor Maria Salvina Signorelli, PhD, MD
- 電話番号：+39 095 3782791
- メール：maria.signorelli@unict.it
研究場所
-
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Sicily
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Catania、Sicily、イタリア、95123
- Psychiatry Unit, Via Santa Sofia 78
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コンタクト：
- Professor Maria Salvina Signorelli, PhD, MD
- 電話番号：+39 095 3782791
- メール：maria.signorelli@unict.it
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副調査官：
- Dr Fabrizio Bella, MD
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副調査官：
- Professor Antonino Petralia, PhD, MD
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副調査官：
- Professor Carmen Concerto, PhD, MD
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副調査官：
- Dr Ludovico Mineo, PhD, MD
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副調査官：
- Dr Lucia Basile, MD
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副調査官：
- Professor Cinzia Santa Di Pietro, PhD
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Enna、Sicily、イタリア、94100
- Psychiatry Unit, Contrada Ferrante SNC
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コンタクト：
- Professor Antonino Messina, PhD, MD
- 電話番号：+39 0935 516044
- メール：antonino.messina2@unikore.it
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Messina、Sicily、イタリア、98125
- Cellular and Molecular Biology Laboratory, Tower of Biological Laboratories, 5th Floor Via Consolare Valeria 1
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コンタクト：
- Professor Angela D'Ascola, PhD
- 電話番号：+39 090 221 3389
- メール：adascola@unime.it
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副調査官：
- Professor Michele Scuruchi, PhD
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副調査官：
- Professor Salvatore Campo, PhD
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副調査官：
- Professor Giuseppe Maurizio Campo, PhD
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副調査官：
- Dr Angela Avenoso, PhD
-
Messina、Sicily、イタリア、98125
- Psychiatry Unit, Via Consolare Valeria 1
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コンタクト：
- Professor Maria Rosaria Anna Muscatello, PhD, MD
- 電話番号：+39 090 2217384
- メール：maria.muscatello@unime.it
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Palermo、Sicily、イタリア、90127
- Psychiatry Unit, Via del Vespro 129
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コンタクト：
- Professor Diego Quattrone, PhD, MD
- 電話番号：+39 091 238 93011
- メール：diego.quattrone@unipa.it
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副調査官：
- Dr Giovanna Marrazzo, PhD, MD
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-
参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
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).
|
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).
|
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).
|
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).
|
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).
|
|
Healthy Control Cohort
Healthy volunteers without current psychiatric disorders or psychotropic medication use, assessed at baseline only.
|
Gene expression analysis of selected non-coding RNAs using reverse transcription quantitative polymerase chain reaction (RT-qPCR).
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Differential Expression of Selected Non-Coding RNAs in Psychiatric Disorders
時間枠：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)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Changes in Non-Coding RNA Expression After Pharmacological Treatment
時間枠：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
時間枠：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
時間枠：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)
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 10/2026/CL-PAR
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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