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Role of Inflammation Factors and Insulin Resistance in Major Depressive Disorder

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 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: September 26, 2014
Last verified: September 2014
  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

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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: September 26, 2014
Health Authority: Taiwan: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on November 25, 2014