Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06580535

Effect of Esterogen Receptor Modulator on Gene in Bipolar Diseas

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

About this study

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 .

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

  • Patients who have a concurrent sever illness like cancer ,liver disease
  • receiving additional treatment

Treatment and study plan

blood sample

Other

Blood sample taking from patient for tissue culture

Primary outcomes

  1. change in Young Mania Rating Scale(YMRS) Score

    Time frame: e.g.4 weeks

    Mean change in YMRS score from baseline to the end of treatment (range:0-60;higher score indicate sever mania)

Secondary outcomes

  1. Percentage of Participants with Treatment Response

    Time frame: e.g.,4 weeks

    Percentage of participants with a ≥50% reduction in attack rating scores from baseline to end of treatment.

Study contacts

Contact information is provided by the study sponsor or research team.

Marina Kamal Fahmy, DR

CONTACT

[email protected]

01200230153

Naglaa kamal idris, professor

CONTACT

[email protected]

01003830234

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 30, 2024
Registry last updated
Aug 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.