Role of Inflammation Factors and Insulin Resistance in Major Depressive Disorder

This study is currently recruiting participants.
Verified September 2012 by National Cheng-Kung University Hospital
Sponsor:
Collaborator:
National Science Council, Taiwan
Information provided by (Responsible Party):
Po-See, Chen, National Cheng-Kung University Hospital
ClinicalTrials.gov Identifier:
NCT01699490
First received: September 30, 2012
Last updated: October 2, 2012
Last verified: September 2012
  Purpose

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


Condition Intervention Phase
Major Depressive Disorder
Drug: Fluoxetine + Valsartan
Drug: Fluoxetine + Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Role of Inflammation Factors and Insulin Resistance in the Pathophysiology and Treatment Response of Major Depressive Disorder

Resource links provided by NLM:


Further study details as provided by National Cheng-Kung University Hospital:

Primary Outcome Measures:
  • Hamilton Depression Rating Scale (HDRS) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • fasting plasma glucose [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • fasting serum insulin [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • C-reactive Protein, and IL-6 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: August 2012
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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

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.
Other Names:
  • Prozac
  • Diovan
Active Comparator: 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

Drug: Fluoxetine + Placebo
The curative effect of fluoxetine add-on placebo therapy in the treatment of major depressive disorder.
Other Name: Prozac

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01699490

Contacts
Contact: Po See Chen, M.D., Ph.D. +886-6-2353535 ext 5213 chenps@mail.ncku.edu.tw

Locations
Taiwan
Department of Psychiatry, National Cheng-Kung University Hospital Recruiting
Tainan, Taiwan, 701
Contact: Po See Chen, M.D., Ph.D.    +886-6-2353535 ext 5213    chenps@mail.ncku.edu.tw   
Sponsors and Collaborators
National Cheng-Kung University Hospital
National Science Council, Taiwan
Investigators
Principal Investigator: Po See Chen, M.D., Ph.D National Cheng-Kung University Hospital
  More Information

No publications provided

Responsible Party: Po-See, Chen, Associate Professor, National Cheng-Kung University Hospital
ClinicalTrials.gov Identifier: NCT01699490     History of Changes
Other Study ID Numbers: NSC 101-2314-B-006 -064 -MY3
Study First Received: September 30, 2012
Last Updated: October 2, 2012
Health Authority: Taiwan: Institutional Review Board

Keywords provided by National Cheng-Kung University Hospital:
Major Depressive Disorder
Antidepressants
Insulin
Fluoxetine

Additional relevant MeSH terms:
Depressive Disorder
Depression
Inflammation
Insulin Resistance
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Pathologic Processes
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Fluoxetine
Insulin
Valsartan
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Hypoglycemic Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on April 17, 2014