Role of Inflammation Factors and Insulin Resistance in Major Depressive Disorder
1 other identifier
interventional
200
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 major-depressive-disorder
Started Aug 2012
Typical duration for phase_4 major-depressive-disorder
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2012
CompletedFirst Submitted
Initial submission to the registry
September 30, 2012
CompletedFirst Posted
Study publicly available on registry
October 3, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedSeptember 29, 2014
September 1, 2014
2.9 years
September 30, 2012
September 26, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hamilton Depression Rating Scale (HDRS)
12 weeks
Secondary Outcomes (3)
fasting plasma glucose
12 weeks
fasting serum insulin
12 weeks
C-reactive Protein, and IL-6
12 weeks
Study Arms (2)
Fluoxetine + Valsartan
EXPERIMENTALThe 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
Fluoxetine + Placebo
ACTIVE COMPARATORThe 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
Interventions
The curative effect of fluoxetine add-on valsartan 40 mg per day for 12 weeks therapy in the treatment of major depressive disorder.
The curative effect of fluoxetine add-on placebo therapy in the treatment of major depressive disorder.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Psychiatry, National Cheng-Kung University Hospital
Tainan, 701, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Po See Chen, M.D., Ph.D
National Cheng-Kung University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
September 30, 2012
First Posted
October 3, 2012
Study Start
August 1, 2012
Primary Completion
July 1, 2015
Study Completion
July 1, 2015
Last Updated
September 29, 2014
Record last verified: 2014-09