Bipolar DisorderNCT06580535
Effect of Esterogen Receptor Modulator on Gene in Bipolar Diseas
An observational study of Bipolar Disorder, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 70 years
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- blood sample
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 5 Sep 2024to Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 70 years
- All sexes
- Child, Adult, Older adult
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)
Who may be able to join
- 1. Fifty subjects 2.15-70 years of age 3.recently diagnosed as bipolar disorder 4.assigned to receive traditional treatment of bipolar disorder
Who cannot join
- Patients who have a concurrent sever illness like cancer ,liver disease
- receiving additional treatment
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Impact of Estrogen Receptor Modulators on Mania Patients and Its Relationship With Genetic Polymorphism of Phospholipase C Epsilon1
- 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.
- Systematically estimate the effects of Phospholipase C epsilon 1 gene (PLCE1) rs2274223and gene polymorphism on the susceptibility to treatment.
- 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.
Read the 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 .
- Conditions
- Bipolar Disorder
- Being tested
- blood sample
- Keywords
- Mania
- Medical subject headings
- Bipolar Disorder, Mania
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sampleOther
Blood sample taking from patient for tissue culture
| Study group | Role | What they receive |
|---|---|---|
| group 1 (patients) | 50 patients assigned to receive treatment of bipolar disorder Receives: 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 Receives: Other: blood sample | |
| group 3 control | GroupIII:50 healthy control will be recruited (age and sex will be matched Receives: Other: blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: e.g.4 weeks
Secondary outcomes (1)
Percentage of Participants with Treatment Response
Percentage of participants with a ≥50% reduction in attack rating scores from baseline to end of treatment.
Measured: e.g.,4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study start5 Sep 2024 (estimated)
- Primary completionAug 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marina Kamal Fahmy, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06580535
- Sponsor's protocol ID
- bipolar disorder
- Status last verified
- Aug 2024
- First submitted
- 31 May 2024
- Last updated
- 30 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34642461Yetisgin 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.
PubMed 32397080Palmer 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.
PubMed 22805490Hu 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.
PubMed 22203178Zhang 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.
PubMed 33162810Khan 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.
PubMed 37521645
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Estrogen Receptor Modulators on Mania Patients and Its Relationship With Genetic Polymorphism of Phospholipase C Epsilon1
- ClinicalTrials.gov ID
- NCT06580535
- Acronym / sponsor ID
- bipolar disorder
- Conditions
- Bipolar Disorder
- Keywords
- Mania
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 5 Sep 2024 (estimated)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 30 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
- Systematically estimate the effects of Phospholipase C epsilon 1 gene (PLCE1) rs2274223and gene polymorphism on the susceptibility to treatment.
- 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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group 1 (patients) | – | Other: blood sample50 patients assigned to receive treatment of bipolar disorder |
| Group 2 recrutied blood from patients | – | Other: blood sampleGroupII: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 | – | Other: blood sampleGroupIII:50 healthy control will be recruited (age and sex will be matched |
Who may qualify
- Ages
- 15 to 70 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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)
Key inclusion criteria (1 listed)
- 1. Fifty subjects 2.15-70 years of age 3.recently diagnosed as bipolar disorder 4.assigned to receive traditional treatment of bipolar disorder
Key exclusion criteria (2 listed)
- Patients who have a concurrent sever illness like cancer ,liver disease
- receiving additional treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood sampleBlood sample taking from patient for tissue culture | Other | Group 2 recrutied blood from patients, group 1 (patients), group 3 control |
Primary outcome
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)
1 secondary outcome
Percentage of Participants with Treatment Response
Time frame: e.g.,4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2024.
- Background: PubMed 34642461Kishi 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.
- Background: PubMed 32397080Yetisgin 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.
- Background: PubMed 22805490Palmer 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.
- Background: PubMed 22203178Hu 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.
- Background: PubMed 33162810Zhang 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.
- Background: PubMed 37521645Khan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Bipolar Disorder, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marina Kamal Fahmy, DR (01200230153, marinakamal391997@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in Young Mania Rating Scale(YMRS) Score (time frame: e.g.4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06580535, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2024.