A Phase 4 interventional study of Fluoxetine + Valsartan and Fluoxetine + Placebo in Major Depressive Disorder, sponsored by National Cheng-Kung University Hospital. Status unknown at 1 site in Taiwan. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2014-09-29.
Sponsored by National Cheng-Kung University Hospital · Phase 4, Interventional, and Treatment
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
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.
1,960 studies on the registry are indexed under Insulin Resistance; 306 are open to participants now.
This study's planned enrollment of 200 is above the median of 40 across 1,536 interventional studies indexed under Insulin Resistance.
Browse Insulin Resistance studies →National Cheng-Kung University Hospital is the lead sponsor of 268 studies on the registry; 68 are open to participants now.
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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 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 valsartan 40 mg per day for 12 weeks therapy in the treatment of major depressive disorder.
Also known as: Prozac, Diovan
The curative effect of fluoxetine add-on placebo therapy in the treatment of major depressive disorder.
Also known as: Prozac
Hamilton Depression Rating Scale (HDRS)
Time frame: 12 weeks
fasting plasma glucose
Time frame: 12 weeks
fasting serum insulin
Time frame: 12 weeks
C-reactive Protein, and IL-6
Time frame: 12 weeks
This study is status unknown, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.
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National Cheng-Kung University Hospital