Effect of Esterogen Receptor Modulator on Gene in Bipolar Diseas

Not yet recruiting

• Conditions: Bipolar Disorder
• Interventions: Other: blood sample

• Registration Number: NCT06580535
• Lead Sponsor: Assiut University

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 Timeline

• Study First Submitted: 2024-05-31
• Status Verified: 2024-08
• Study First Submitted QC: 2024-08-29
• Last Update Submitted: 2024-08-29
• Study First Posted: 2024-08-30
• Last Update Posted: 2024-08-30
• Study Start: 2024-09-05
• Primary Completion: 2025-08
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
group 1 (patients)	blood sample	50 patients assigned to receive treatment of bipolar disorder
Group 2 recrutied blood from patients	blood sample	GroupII:50 blood sample will be recruited from G1for in vitro tissue culture to study the effect of tamoxifen on the WBCs of patients
group 3 control	blood sample	GroupIII:50 healthy control will be recruited (age and sex will be matched

Primary Outcome Measures

Name	Time	Method
change in Young Mania Rating Scale(YMRS) Score	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 Outcome Measures

Name	Time	Method
Percentage of Participants with Treatment Response	e.g.,4 weeks	Percentage of participants with a ≥50% reduction in attack rating scores from baseline to end of treatment.