Viewing Study NCT06580535


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Ignite Modification Date: 2026-01-01 @ 3:59 PM
Study NCT ID: NCT06580535
Status: NOT_YET_RECRUITING
Last Update Posted: 2024-08-30
First Post: 2024-05-31
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Effect of Esterogen Receptor Modulator on Gene in Bipolar Diseas
Sponsor: Assiut University
Organization:

Study Overview

Official Title: Impact of Estrogen Receptor Modulators on Mania Patients and Its Relationship With Genetic Polymorphism of Phospholipase C Epsilon1
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: 1. Identify randomized controlled trials of tamoxifen (Estrogen Receptor modulator) in in addition to traditional treatment of bipolar disorder and synthesize the results using meta-analysis.
2. Systematically estimate the effects of Phospholipase C epsilon 1 gene (PLCE1) rs2274223and gene polymorphism on the susceptibility to treatment.
3. Study the pathway involved in the action of tamoxifen by incorporating TMX into nanoparticles and evaluating tyrosine kinase in responders WBCS culture and evaluate nanoparticle as a hope for future treatment of CNS disorders.
Detailed Description: Bipolar disorder, formerly known as manic depression, is typified by severe mood fluctuations with emotional highs (mania or hypomania) and lows (depression). Tamoxifen \[TMX\], an oral medication, has been proposed as a potential treatment for bipolar disorder. Tamoxifen)modulator of the Estrogen Recptor) functions by blocking the intracellular action of protein kinase C, which is the mechanism by which popular treatments for bipolar disorder such as valproate and lithium function. . Targeted therapy benefits greatly from drug delivery methods based on nanoparticles because they enhance bioavailability, decrease side effects, and increase efficiency. .

Enzymes belonging to the PKC class are essential for cell signaling. Data from previous studies suggest that increased PKC activity may affect the prefrontal cortical regulation of behavior and thinking. PKC is unique in that it is controlled by tyrosine phosphorylation and has several subcellular destinations . In a study of bipolar individuals who responded well to lithium, a variant in the phospholipase C gene, which codes for the first enzyme in the PKC cascade, was discovered .

The 26th exon of the Phospholipase C epsilon1gene (PLCE1) gene contains the non-synonymous SNP Rs2274223, which can change one amino acid from histidine to arginine 6. SNP rs2274223 in PLCE1 is one of the polymorphic loci that has been studied the most .

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: