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Role of Inflammation Factors and Insulin Resistance in Major Depressive Disorder

Primary Purpose

Major Depressive Disorder

Status
Unknown status
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Fluoxetine + Valsartan
Fluoxetine + Placebo
Sponsored by
National Cheng-Kung University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Major Depressive Disorder, Antidepressants, Insulin, Fluoxetine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Psychiatry, National Cheng-Kung University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Fluoxetine + Valsartan

Fluoxetine + Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Hamilton Depression Rating Scale (HDRS)

Secondary Outcome Measures

fasting plasma glucose
fasting serum insulin
C-reactive Protein, and IL-6

Full Information

First Posted
September 30, 2012
Last Updated
September 26, 2014
Sponsor
National Cheng-Kung University Hospital
Collaborators
National Science Council, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT01699490
Brief Title
Role of Inflammation Factors and Insulin Resistance in Major Depressive Disorder
Official Title
Role of Inflammation Factors and Insulin Resistance in the Pathophysiology and Treatment Response of Major Depressive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Unknown status
Study Start Date
August 2012 (undefined)
Primary Completion Date
July 2015 (Anticipated)
Study Completion Date
July 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cheng-Kung University Hospital
Collaborators
National Science Council, Taiwan

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Major Depressive Disorder, Antidepressants, Insulin, Fluoxetine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fluoxetine + Valsartan
Arm Type
Experimental
Arm Description
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
Arm Title
Fluoxetine + Placebo
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Fluoxetine + Valsartan
Other Intervention Name(s)
Prozac, Diovan
Intervention Description
The curative effect of fluoxetine add-on valsartan 40 mg per day for 12 weeks therapy in the treatment of major depressive disorder.
Intervention Type
Drug
Intervention Name(s)
Fluoxetine + Placebo
Other Intervention Name(s)
Prozac
Intervention Description
The curative effect of fluoxetine add-on placebo therapy in the treatment of major depressive disorder.
Primary Outcome Measure Information:
Title
Hamilton Depression Rating Scale (HDRS)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
fasting plasma glucose
Time Frame
12 weeks
Title
fasting serum insulin
Time Frame
12 weeks
Title
C-reactive Protein, and IL-6
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Po See Chen, M.D., Ph.D.
Phone
+886-6-2353535
Ext
5213
Email
chenps@mail.ncku.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Po See Chen, M.D., Ph.D
Organizational Affiliation
National Cheng-Kung University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Psychiatry, National Cheng-Kung University Hospital
City
Tainan
ZIP/Postal Code
701
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Po See Chen, M.D., Ph.D.
Phone
+886-6-2353535
Ext
5213
Email
chenps@mail.ncku.edu.tw

12. IPD Sharing Statement

Learn more about this trial

Role of Inflammation Factors and Insulin Resistance in Major Depressive Disorder

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