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Not Yet Recruiting NCT07649993

Non-Coding RNAs Gene Expression in Psychiatric Disorders

Conditions: Schizophrenia Disorders, Major Depression, Bipolar Affective Disorders, Obsessive Compulsive Disorder (OCD), Anxiety Disorder (Panic Disorder or GAD)

Sex: All
Ages: 18 Years – 55 Years
Healthy volunteers: Yes
Enrollment: 384
Sponsor: Carmen Concerto

Location: Psychiatry Unit, Via Santa Sofia 78 Catania Sicily

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. 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.

Eligibility Criteria

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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07649993). StuddyBuddy aggregates publicly available trial information.