Role of Inflammation Factors and Insulin Resistance in Major Depressive Disorder

National Cheng-Kung University Hospital200 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

200

Conditions

Major Depressive Disorder

Interventions

Fluoxetine + ValsartanDRUG

The curative effect of fluoxetine add-on valsartan 40 mg per day for 12 weeks therapy in the treatment of major depressive disorder.

Fluoxetine + PlaceboDRUG

The curative effect of fluoxetine add-on placebo therapy in the treatment of major depressive disorder.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Psychiatry, National Cheng-Kung University Hospital

Tainan, Taiwan

RECRUITING

Outcomes

Primary Outcomes

Hamilton Depression Rating Scale (HDRS)

Time frame: 12 weeks

Secondary Outcomes

fasting plasma glucose

Time frame: 12 weeks

fasting serum insulin

Time frame: 12 weeks

C-reactive Protein, and IL-6

Time frame: 12 weeks

Central Contacts

Po See Chen, M.D., Ph.D.

CONTACT

+886-6-2353535 chenps@mail.ncku.edu.tw

Data from ClinicalTrials.gov

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