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Effect of Esterogen Receptor Modulator on Gene in Bipolar Diseas

Impact of Estrogen Receptor Modulators on Mania Patients and Its Relationship With Genetic Polymorphism of Phospholipase C Epsilon1

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06580535
Enrollment
100
Registered
2024-08-30
Start date
2024-09-05
Completion date
2025-12-31
Last updated
2024-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar Disorder

Keywords

Mania

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 .

Interventions

OTHERblood sample

Blood sample taking from patient for tissue culture

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
15 Years to 70 Years

Inclusion criteria

1\. Fifty subjects 2.15-70 years of age 3.recently diagnosed as bipolar disorder 4.assigned to receive traditional treatment of bipolar disorder

Exclusion criteria

1. Patients who have a concurrent sever illness like cancer ,liver disease 2. receiving additional treatment

Design outcomes

Primary

MeasureTime frameDescription
change in Young Mania Rating Scale(YMRS) Scoree.g.4 weeksMean change in YMRS score from baseline to the end of treatment (range:0-60;higher score indicate sever mania)

Secondary

MeasureTime frameDescription
Percentage of Participants with Treatment Responsee.g.,4 weeksPercentage of participants with a ≥50% reduction in attack rating scores from baseline to end of treatment.

Contacts

Primary ContactMarina Kamal Fahmy, DR
marinakamal391997@gmail.com01200230153
Backup ContactNaglaa kamal idris, professor
naglaaidris@hotmail.com01003830234

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026