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| Name | Class |
|---|---|
| National Science and Technology Council, Taiwan | OTHER_GOV |
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The purpose of this study is to identify evidence-based guidelines for treating major depressive disorder to full remission in Taiwanese major depressive disorder (MDD) patients. To achieve this goal, the investigators aim to: (1) evaluate the risks and benefits of adjunctive pharmacotherapies for cognitive and metabolic consequences in MDD, and (2) clarify the shared biological mechanisms between mood, immune and metabolism homeostasis
The prevalence of insulin resistance did not significantly differ among the healthy controls and drug-naïve MDD patients before and after antidepressant treatment. Meanwhile, the current study indicated that antidepressants might affect insulin secretion independently of the therapeutic effects on MDD. Therapeutic strategies considering both treatment effectiveness and glucose-insulin homeostasis in MDD patients are necessary.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluoxetine + Valsartan | Experimental | The initial dose of fluoxetine was 20 mg once daily, which could be increased by 20 mg in divided doses to a maximal daily dose of 60 mg. Add-on treatment to 40 mg per day of valsartan |
|
| Fluoxetine + Placebo | Active Comparator | The initial dose of fluoxetine was 20 mg once daily, which could be increased by 20 mg in divided doses to a maximal daily dose of 60 mg. Add-on treatment to placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluoxetine + Valsartan | Drug | The curative effect of fluoxetine add-on valsartan 40 mg per day for 12 weeks therapy in the treatment of major depressive disorder. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hamilton Depression Rating Scale (HDRS) | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| fasting plasma glucose | 12 weeks | |
| fasting serum insulin | 12 weeks | |
| C-reactive Protein, and IL-6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Po See Chen, M.D., Ph.D. | Contact | +886-6-2353535 | 5213 | chenps@mail.ncku.edu.tw |
| Name | Affiliation | Role |
|---|---|---|
| Po See Chen, M.D., Ph.D | National Cheng-Kung University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Psychiatry, National Cheng-Kung University Hospital | Recruiting | Tainan | 701 | Taiwan |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D006946 | Hyperinsulinism |
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| ID | Term |
|---|---|
| D005473 | Fluoxetine |
| D000068756 | Valsartan |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D013777 | Tetrazoles |
| D001393 |
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|
| Fluoxetine + Placebo | Drug | The curative effect of fluoxetine add-on placebo therapy in the treatment of major depressive disorder. |
|
|
| 12 weeks |
| D044882 |
| Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D014633 | Valine |
| D000597 | Amino Acids, Branched-Chain |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000601 | Amino Acids, Essential |