Schizophrenia DisordersPsiRNA26NCT07649993
Non-Coding RNAs Gene Expression in Psychiatric Disorders
An observational study of Schizophrenia Disorders and Major Depression, run by Carmen Concerto at 5 sites in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia Disorders, Major Depression, Bipolar Affective Disorders
- What is being tested?
- Reverse Transcription Quantitative Polymerase Chain Reaction
- How many people
- 384 participants
- Where
- 5 sitesItaly
- Study dates
- 1 Sep 2026to 1 Sep 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 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.
Who may be able to join
- 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,
Show all 20Show fewer
- Obsessive-Compulsive Disorder,
- Schizophrenia;
- First diagnosis and drug-naive status, or absence of psychopharmacological treatment for at least 6 months prior to enrollment.
- 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.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Italy5 sites
Psychiatry Unit, Via Santa Sofia 78
Catania, Sicily, 95123
Professor Maria Salvina Signorelli, PhD, MD, +39 095 3782791, maria.signorelli@unict.it
Dr Fabrizio Bella, MD
Psychiatry Unit, Contrada Ferrante SNC
Enna, Sicily, 94100
Professor Antonino Messina, PhD, MD, +39 0935 516044, antonino.messina2@unikore.it
Cellular and Molecular Biology Laboratory, Tower of Biological Laboratories, 5th Floor Via Consolare Valeria 1
Messina, Sicily, 98125
Professor Angela D'Ascola, PhD, +39 090 221 3389, adascola@unime.it
Professor Michele Scuruchi, PhD
Psychiatry Unit, Via Consolare Valeria 1
Messina, Sicily, 98125
Professor Maria Rosaria Anna Muscatello, PhD, MD, +39 090 2217384, maria.muscatello@unime.it
Psychiatry Unit, Via del Vespro 129
Palermo, Sicily, 90127
Professor Diego Quattrone, PhD, MD, +39 091 238 93011, diego.quattrone@unipa.it
Dr Giovanna Marrazzo, PhD, MD
About this study
Official title: 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.
Read more
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.
Read the detailed description
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.
- Conditions
- Schizophrenia Disorders, Major Depression, Bipolar Affective Disorders, Obsessive Compulsive Disorder (OCD), Anxiety Disorder (Panic Disorder or GAD)
- Being tested
- Reverse Transcription Quantitative Polymerase Chain Reaction
- Medical subject headings
- Schizophrenia, Depressive Disorder, Major, Obsessive-Compulsive Disorder, Anxiety Disorders, Panic Disorder, Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reverse Transcription Quantitative Polymerase Chain ReactionGenetic
Gene expression analysis of selected non-coding RNAs using reverse transcription quantitative polymerase chain reaction (RT-qPCR).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Genetic: Reverse Transcription Quantitative Polymerase Chain Reaction | |
| 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). Receives: Genetic: Reverse Transcription Quantitative Polymerase Chain Reaction | |
| 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). Receives: Genetic: Reverse Transcription Quantitative Polymerase Chain Reaction | |
| 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). Receives: Genetic: Reverse Transcription Quantitative Polymerase Chain Reaction | |
| 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). Receives: Genetic: Reverse Transcription Quantitative Polymerase Chain Reaction | |
| Healthy Control Cohort | Healthy volunteers without current psychiatric disorders or psychotropic medication use, assessed at baseline only. Receives: Genetic: Reverse Transcription Quantitative Polymerase Chain Reaction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differential Expression of Selected Non-Coding RNAs in Psychiatric Disorders
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.
Measured: Baseline (T0)
Secondary outcomes (3)
Changes in Non-Coding RNA Expression After Pharmacological Treatment
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.
Measured: Baseline (T0) and 5 months (T1)
Differences in ncRNA Expression Between Psychiatric Patients and Healthy Controls
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.
Measured: Baseline (T0)
Differences in ncRNA Expression Between Manic and Depressive Episodes in Bipolar Disorder
Evaluation of differential expression of selected ncRNAs in patients with Bipolar Disorder during manic episodes compared with depressive episodes at baseline assessment.
Measured: Baseline (T0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophrenia DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 384 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carmen Concerto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Carmen Concerto, University of Catania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07649993
- Sponsor's protocol ID
- 10/2026/CL-PAR
- Acronym
- PsiRNA26
- Status last verified
- Jun 2026
- First submitted
- 10 Jun 2026
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gene Expression Analysis of Non-coding RNAs in Psychiatric Disorders
- ClinicalTrials.gov ID
- NCT07649993
- Acronym / sponsor ID
- PsiRNA26 / 10/2026/CL-PAR
- Conditions
- Schizophrenia Disorders, Major Depression, Bipolar Affective Disorders, Obsessive Compulsive Disorder (OCD), Anxiety Disorder (Panic Disorder or GAD)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 384 participants (estimated)
- Lead sponsor
- Carmen ConcertoUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 16 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Major Depressive Disorder Cohort | – | Genetic: Reverse Transcription Quantitative Polymerase Chain ReactionDrug-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). |
| Schizophrenia Cohort | – | Genetic: Reverse Transcription Quantitative Polymerase Chain ReactionDrug-naïve or drug-free patients diagnosed with Schizophrenia, assessed at baseline (T0) and after at least five months of standard pharmacological treatment (T1). |
| Obsessive-Compulsive Disorder Cohort | – | Genetic: Reverse Transcription Quantitative Polymerase Chain ReactionDrug-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). |
| Panic Disorder Cohort | – | Genetic: Reverse Transcription Quantitative Polymerase Chain ReactionDrug-naïve or drug-free patients diagnosed with Panic Disorder, assessed at baseline (T0) and after at least five months of standard pharmacological treatment (T1). |
| Bipolar Disorder Cohort | – | Genetic: Reverse Transcription Quantitative Polymerase Chain ReactionDrug-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). |
| Healthy Control Cohort | – | Genetic: Reverse Transcription Quantitative Polymerase Chain ReactionHealthy volunteers without current psychiatric disorders or psychotropic medication use, assessed at baseline only. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 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.
Key inclusion criteria (20 listed)
- 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,
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reverse Transcription Quantitative Polymerase Chain ReactionGene expression analysis of selected non-coding RNAs using reverse transcription quantitative polymerase chain reaction (RT-qPCR). | Genetic | Bipolar Disorder Cohort, Healthy Control Cohort, Major Depressive Disorder Cohort, Obsessive-Compulsive Disorder Cohort, Panic Disorder Cohort, Schizophrenia Cohort |
Primary outcome
Differential Expression of Selected Non-Coding RNAs in Psychiatric Disorders
Time frame: 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.
3 secondary outcomes
Changes in Non-Coding RNA Expression After Pharmacological Treatment
Time frame: Baseline (T0) and 5 months (T1)
Differences in ncRNA Expression Between Psychiatric Patients and Healthy Controls
Time frame: Baseline (T0)
Differences in ncRNA Expression Between Manic and Depressive Episodes in Bipolar Disorder
Time frame: Baseline (T0)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia Disorders and Major Depression, run by Carmen Concerto at 5 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Professor Maria Salvina Signorelli, PhD, MD (+39 095 3782791, maria.signorelli@unict.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differential Expression of Selected Non-Coding RNAs in Psychiatric Disorders (time frame: Baseline (T0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.