Role of Inflammation Factors and Insulin Resistance in Major Depressive Disorder

This study is currently recruiting participants. (see Contacts and Locations)
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

September 30, 2012
October 2, 2012
August 2012
July 2015   (final data collection date for primary outcome measure)
Hamilton Depression Rating Scale (HDRS) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01699490 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Role of Inflammation Factors and Insulin Resistance in Major Depressive Disorder
Role of Inflammation Factors and Insulin Resistance in the Pathophysiology and Treatment Response of Major Depressive Disorder

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

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Major Depressive Disorder
  • 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
  • Drug: Fluoxetine + Placebo
    The curative effect of fluoxetine add-on placebo therapy in the treatment of major depressive disorder.
    Other Name: Prozac
  • 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

    Intervention: Drug: Fluoxetine + Valsartan
  • 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

    Intervention: Drug: Fluoxetine + Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
July 2015
July 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact: Po See Chen, M.D., Ph.D. +886-6-2353535 ext 5213 chenps@mail.ncku.edu.tw
Taiwan
 
NCT01699490
NSC 101-2314-B-006 -064 -MY3
Yes
Po-See, Chen, National Cheng-Kung University Hospital
National Cheng-Kung University Hospital
National Science Council, Taiwan
Principal Investigator: Po See Chen, M.D., Ph.D National Cheng-Kung University Hospital
National Cheng-Kung University Hospital
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP