Role of Inflammation Factors and Insulin Resistance in Major Depressive Disorder

National Cheng-Kung University

Status and phase: Unknown; Phase 4

Conditions: Major Depressive Disorder

Treatments: Drug: Fluoxetine + Placebo; Drug: Fluoxetine + Valsartan

Study type: Interventional

Funder types: Other

Identifiers

NCT01699490

NSC 101-2314-B-006 -064 -MY3

Details and patient eligibility

About

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

Full description

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups

Fluoxetine + Valsartan

Experimental group

Description:

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

Treatment:

Drug: Fluoxetine + Valsartan

Fluoxetine + Placebo

Active Comparator group

Description:

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

Treatment:

Drug: Fluoxetine + Placebo