Role of Inflammation Factors and Insulin Resistance in Major Depressive Disorder

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01699490
• Other study ID #: NSC 101-2314-B-006 -064 -MY3
• Status: Recruiting
• Phase: Phase 4
• First received: September 30, 2012
• Last updated: September 26, 2014
• Start date: August 2012
• Est. completion date: July 2015

Study information

• Verified date: September 2014
• Source: National Cheng-Kung University Hospital
• Contact: Po See Chen, M.D., Ph.D.
• Phone: +886-6-2353535
• Email: chenps[@]mail.ncku.edu.tw
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Insulin Resistance
• Major Depressive Disorder

Intervention

Drug:
• Fluoxetine + Valsartan
The curative effect of fluoxetine add-on valsartan 40 mg per day for 12 weeks therapy in the treatment of major depressive disorder.
• Fluoxetine + Placebo
The curative effect of fluoxetine add-on placebo therapy in the treatment of major depressive disorder.

Locations

Country	Name	City	State
Taiwan	Department of Psychiatry, National Cheng-Kung University Hospital	Tainan

Sponsors (2)

Lead Sponsor	Collaborator
National Cheng-Kung University Hospital	National Science Council, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hamilton Depression Rating Scale (HDRS)		12 weeks	No
Secondary	fasting plasma glucose		12 weeks	No
Secondary	fasting serum insulin		12 weeks	No
Secondary	C-reactive Protein, and IL-6		12 weeks	No