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Effect of Esterogen Receptor Modulator on Gene in Bipolar Diseas

NCT ID: NCT06580535

Last Updated: 2024-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-09-05

Study Completion Date

2025-12-31

Brief Summary

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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

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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 .

Conditions

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Bipolar Disorder

Keywords

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Mania

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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group 1 (patients)

50 patients assigned to receive treatment of bipolar disorder

blood sample

Intervention Type OTHER

Blood sample taking from patient for tissue culture

Group 2 recrutied blood from patients

GroupII:50 blood sample will be recruited from G1for in vitro tissue culture to study the effect of tamoxifen on the WBCs of patients

blood sample

Intervention Type OTHER

Blood sample taking from patient for tissue culture

group 3 control

GroupIII:50 healthy control will be recruited (age and sex will be matched

blood sample

Intervention Type OTHER

Blood sample taking from patient for tissue culture

Interventions

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blood sample

Blood sample taking from patient for tissue culture

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Marina Kamal Fahmy

Demonstrator

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Marina Kamal Fahmy, DR

Role: CONTACT

Phone: 01200230153

Email: [email protected]

Naglaa kamal idris, professor

Role: CONTACT

Phone: 01003830234

Email: [email protected]

References

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Kishi T, Ikuta T, Matsuda Y, Sakuma K, Okuya M, Nomura I, Hatano M, Iwata N. Pharmacological treatment for bipolar mania: a systematic review and network meta-analysis of double-blind randomized controlled trials. Mol Psychiatry. 2022 Feb;27(2):1136-1144. doi: 10.1038/s41380-021-01334-4. Epub 2021 Oct 12.

Reference Type BACKGROUND
PMID: 34642461 (View on PubMed)

Yetisgin AA, Cetinel S, Zuvin M, Kosar A, Kutlu O. Therapeutic Nanoparticles and Their Targeted Delivery Applications. Molecules. 2020 May 8;25(9):2193. doi: 10.3390/molecules25092193.

Reference Type BACKGROUND
PMID: 32397080 (View on PubMed)

Palmer AJ, Lochhead P, Hold GL, Rabkin CS, Chow WH, Lissowska J, Vaughan TL, Berry S, Gammon M, Risch H, El-Omar EM. Genetic variation in C20orf54, PLCE1 and MUC1 and the risk of upper gastrointestinal cancers in Caucasian populations. Eur J Cancer Prev. 2012 Nov;21(6):541-4. doi: 10.1097/CEJ.0b013e3283529b79.

Reference Type BACKGROUND
PMID: 22805490 (View on PubMed)

Hu H, Yang J, Sun Y, Yang Y, Qian J, Jin L, Wang M, Bi R, Zhang R, Zhu M, Sun M, Ma H, Wei Q, Jiang G, Zhou X, Chen H. Putatively functional PLCE1 variants and susceptibility to esophageal squamous cell carcinoma (ESCC): a case-control study in eastern Chinese populations. Ann Surg Oncol. 2012 Jul;19(7):2403-10. doi: 10.1245/s10434-011-2160-y. Epub 2011 Dec 28.

Reference Type BACKGROUND
PMID: 22203178 (View on PubMed)

Zhang Y, Li W, Wang Y, Wang N. The PLCE1 rs2274223 variant is associated with the risk of laryngeal squamous cell carcinoma. Int J Med Sci. 2020 Oct 8;17(17):2826-2830. doi: 10.7150/ijms.49012. eCollection 2020.

Reference Type BACKGROUND
PMID: 33162810 (View on PubMed)

Khan Z, Sattar S, Abubakar M, Arshed MJ, Aslam R, Shah STA, Javed S, Tariq A, Manzoor S, Bostan N. Preparation and in Vitro Evaluation of Tamoxifen-Conjugated, Eco-Friendly, Agar-Based Hybrid Magnetic Nanoparticles for Their Potential Use in Breast Cancer Treatment. ACS Omega. 2023 Jul 14;8(29):25808-25816. doi: 10.1021/acsomega.3c00844. eCollection 2023 Jul 25.

Reference Type BACKGROUND
PMID: 37521645 (View on PubMed)

Other Identifiers

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bipolar disorder

Identifier Type: -

Identifier Source: org_study_id