Role of Inflammation Factors and Insulin Resistance in Major Depressive Disorder

Phase 4

• Conditions: Major Depressive Disorder
• Interventions: Drug: Fluoxetine + Placebo; Drug: Fluoxetine + Valsartan

• Registration Number: NCT01699490
• Lead Sponsor: National Cheng-Kung University Hospital

Brief Summary

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

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 Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-09-30
• Study First Submitted QC: 2012-10-02
• Study First Posted: 2012-10-03
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-26
• Last Update Posted: 2014-09-29
• Primary Completion: 2015-07
• Study Completion: 2015-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fluoxetine + Placebo	Fluoxetine + Placebo	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
Fluoxetine + Valsartan	Fluoxetine + Valsartan	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

Primary Outcome Measures

Name	Time	Method
Hamilton Depression Rating Scale (HDRS)	12 weeks

Secondary Outcome Measures

Name	Time	Method
fasting serum insulin	12 weeks
fasting plasma glucose	12 weeks
C-reactive Protein, and IL-6	12 weeks

Trial Locations

Locations (1)

Department of Psychiatry, National Cheng-Kung University Hospital; 🇨🇳 Tainan, Taiwan