Effect of Esterogen Receptor Modulator on Gene in Bipolar Diseas

NCT06580535 | Not Yet Recruiting

• 1 other identifier: bipolar disorder
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

1. 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. 2.Systematically estimate the effects of Phospholipase C epsilon 1 gene (PLCE1) rs2274223and gene polymorphism on the susceptibility to treatment.
3. 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.

Conditions

Bipolar Disorder

Keywords

Mania

Outcome Measures

Primary Outcomes (1)

• change in Young Mania Rating Scale(YMRS) Score

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

  e.g.4 weeks

Secondary Outcomes (1)

• Percentage of Participants with Treatment Response

  e.g.,4 weeks

Study Arms (3)

group 1 (patients)

50 patients assigned to receive treatment of bipolar disorder

Other: blood sample

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

Other: blood sample

group 3 control

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

Other: blood sample

Interventions

blood sample OTHER

Blood sample taking from patient for tissue culture

Group 2 recrutied blood from patients; group 1 (patients); group 3 control

Eligibility Criteria

• Age: 15 Years - 70 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (6)

• 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.

  PMID: 34642461 BACKGROUND

• 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.

  PMID: 32397080 BACKGROUND

• 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.

  PMID: 22805490 BACKGROUND

• 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.

  PMID: 22203178 BACKGROUND

• 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.

  PMID: 33162810 BACKGROUND

• 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.

  PMID: 37521645 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample for detection of PLCE1 gene polymorphism in bipolar disorder

MeSH Terms

Conditions

Bipolar Disorder; Mania

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Marina Kamal Fahmy, DR

CONTACT

01200230153; marinakamal391997@gmail.com

Naglaa kamal idris, professor

CONTACT

01003830234; naglaaidris@hotmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Demonstrator

Study Record Dates

• First Submitted: May 31, 2024
• First Posted: August 30, 2024
• Study Start: September 5, 2024
• Primary Completion: August 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 30, 2024

Record last verified: 2024-08