euro-immune, neuro-oxidative and neuro-nitrosative pathways in association with LINE1/Alu methylation in acute schizophrenia

Not Applicable

• Conditions: acute phase of schizophrenia; neuro- immune; oxidative; nitrosative; LINE1/Alu methylation; acute schizophrenia

• Registration Number: TCTR20190103001
• Lead Sponsor: the Ratchadapisek Somphot Fund

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-03
• Study Completion: 2020-02-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

1.An acute phase of schizophrenia (both new onset schizophrenia patients and patients with acute exacerbations) while being able to cooperate with the study protocol (therefore a window of 10 days from admission is allowed). Thus we will include patients in an acute state with positive symptom exacerbations or psychotic decompensation or disorganization.
2.Meet the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition Text-Revised and DSM-5 criteria for schizophrenia.

Exclusion Criteria

1.A current and life-time diagnosis of axis-I DSM IV-TR / DSM-5 disorders other than schizophrenia, e.g. major depression or bipolar disorder, substance use disorders, psycho-organic disorders, etc.
Exclusion criteria for patients and controls are:
1.Medical illnesses, such as inflammatory bowel disease and rheumatoid arthritis; COPD; neurodegenerative disorders; diabetes type 1 and 2, dementia, Parkinson’s and Huntington’s disease, stroke, etc.
2.Treatments with immunomodulatory drugs, including glucocorticoids; and c) alcohol abuse.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
euroimmune biomarkers crossectional Neurocognitive tests and blood examination

Secondary Outcome Measures

Name	Time	Method
Skin Elasticity at left/right upper cheek day 1, day 30, day 60, day 90 Cutometer® dual mpa 580 ,TEWL measurement day 1, day 30, day 60, day 90 Tewameter® TM210,Dermal fluid level of procollagen type 1, elastin, fibrillin and biglycan day 1, day 30, day 60, day 90 ELISA test,Skin Moisture, Elasticity, Clarity, Wrinkle, Rejuvenation and Overall skin condition day 1, day 30, day 60, day 90 Self-Assessment score,Frequency of GI effects, skin effects, other allergenic reactions and Product palatability day 1, day 30, day 60, day 90 Self-Assessment score,Biochemical parameter day 1, day 30, day 60, day 90 Blood laboratory test