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| Name | Class |
|---|---|
| Manal Ali Mahrous Hamouda Faculty of Pharmacy, Menufia University | UNKNOWN |
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Major depressive disorder (MDD) is a significant cause of disability that affects approximately 16% of the world's population and is associated with chronic inflammation. Although the mechanisms of MDD have not yet been clearly elucidated, NLRP3 inflammasomes have been implicated in the pathogenesis of depression.NLRP3 inflammasome is an intracellular multiprotein complex that consists of nod-like receptor protein 3, an adaptor protein, and a procaspase-1 precursor. It is well known that a variety of danger signals, such as pathogen-associated molecular patterns and danger-associated molecular patterns can activate NLRP3 inflammasome
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Active Comparator | Control group ( fluoxetine 20 mg, n =25 ) who will receive fluoxetine (20 mg) once daily for 3 months |
|
| Dapagliflozin group | Active Comparator | Patients will receive fluoxetine (20 mg) once daily plus dapagliflozin 10 mg once daily for 3 months |
|
| Atorvastatin group | Active Comparator | Patients will receive fluoxetine (20 mg) once daily plus atorvastatin 80 mg once daily for 3 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluoxetine 20 mg | Drug | Fluoxetine is a type of antidepressant known as a selective serotonin reuptake inhibitor (SSRI). It's often used to treat depression, and sometimes obsessive-compulsive disorder and bulimia. It works by increasing the levels of serotonin in the brain |
| Measure | Description | Time Frame |
|---|---|---|
| • The primary endpoint is the change in Hamilton Rating Scale | • The primary endpoint is the change in Hamilton Rating Scale | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| The secondary endpoint is estimated by changes in serum biomarkers. | The secondary endpoint is estimated by changes in serum biomarkers such as F) Nuclear factor erythroid 2-related factor 2 | 3 months |
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Inclusion Criteria:
- Age ≥ 18 years Both males and females will be included Negative pregnancy test and effective contraception. Depressed patients for at least 2 months with a Hamilton rating score of more than 18.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine, Menoufia University | Tanta | Shebeen El-Kom | 32511 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38855751 | Derived | Aldossary KM, Ali LS, Abdallah MS, Bahaa MM, Elmasry TA, Elberri EI, Kotkata FA, El Sabaa RM, Elmorsi YM, Kamel MM, Negm WA, Elberri AI, Hamouda AO, AlRasheed HA, Salahuddin MM, Yasser M, Hamouda MA. Effect of a high dose atorvastatin as added-on therapy on symptoms and serum AMPK/NLRP3 inflammasome and IL-6/STAT3 axes in patients with major depressive disorder: randomized controlled clinical study. Front Pharmacol. 2024 May 24;15:1381523. doi: 10.3389/fphar.2024.1381523. eCollection 2024. |
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| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| ID | Term |
|---|---|
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D005473 | Fluoxetine |
| C529054 | dapagliflozin |
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D011758 | Pyrroles |
| D001393 |
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double-blind
| Dapagliflozin 10mg Tab | Drug | Dapagliflozin (DAPA), a sodium-glucose co-transporter 2 inhibitor (SGLT2-I), has proven to be an effective hyperglycemic suppressor due to its role in inhibiting the reabsorption of 30-50% of the glucose filtered by the kidney, besides its role in the improvement of insulin resistance |
|
| Atorvastatin 80mg | Drug | Atorvastatin is a synthetic and lipophilic statin, a class of drugs used in the treatment of hypercholesterolemia |
|
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |