Role of Inflammation Factors and Insulin Resistance in Major Depressive Disorder

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Role of Inflammation Factors and Insulin Resistance in the Pathophysiology and Treatment Response of Major Depressive Disorder

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Drug: Fluoxetine + Valsartan
* Drug: Fluoxetine + Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 16-65 years old Signed informed consent by patient or legal representative Hamilton Rating Scale for Depression (HDRS) scores ≥ 16 A diagnosis of MDD according to DSM-IV criteria made by a specialist in psychiatry Exclusion Criteria: Monoamine oxidase inhibitor or antidepressant treatment prior to entering the study A DSM-IV diagnosis of substance abuse within the past three months An organic mental disease, mental retardation or dementia A serious surgical condition or physical illness Patients who were pregnant or breastfeeding

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fluoxetine + Valsartan<br>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 | Drug: Fluoxetine + Valsartan<br>* The curative effect of fluoxetine add-on valsartan 40 mg per day for 12 weeks therapy in the treatment of major depressive disorder.<br>* Other names: Diovan;|
| Active Comparator: Fluoxetine + Placebo<br>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 | Drug: Fluoxetine + Placebo<br>* The curative effect of fluoxetine add-on placebo therapy in the treatment of major depressive disorder.<br>* Other names: Prozac;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Depression Rating Scale (HDRS) |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fasting plasma glucose |  | 12 weeks | 
| fasting serum insulin |  | 12 weeks | 
| C-reactive Protein, and IL-6 |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Major Depressive Disorder, Antidepressants, Insulin, Fluoxetine