Major Depressive Disorder
Conditions
Keywords
Major Depressive Disorder, Antidepressants, Insulin, Fluoxetine
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.
Interventions
DRUGFluoxetine + Valsartan
The curative effect of fluoxetine add-on valsartan 40 mg per day for 12 weeks therapy in the treatment of major depressive disorder.
DRUGFluoxetine + Placebo
The curative effect of fluoxetine add-on placebo therapy in the treatment of major depressive disorder.
Sponsors
National Science and Technology Council, Taiwan
National Cheng-Kung University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hamilton Depression Rating Scale (HDRS) | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| fasting plasma glucose | 12 weeks |
| fasting serum insulin | 12 weeks |
| C-reactive Protein, and IL-6 | 12 weeks |
Countries
Taiwan
Contacts
Primary ContactPo See Chen, M.D., Ph.D.
Outcome results
None listed