Abstract
Objective:To evaluate the efficacy and safety of duloxetine enteric coated tablets in patients with depressive disorders. Methods:A double-blind, double-dummy, parallel randomized controlled study was carried out for 51 patients who met the DSM-IV criteria of depression and depressed episode. 25 of the total patients were treated with duloxetine (40-60 mg·d-1) and the rest were treated with paroxetine (20mg·d-1) for 8 weeks. Efficacy was then assessed by Hamilton Depression Rating Scale (HAMD), Hamilton Anxiety Scale(HAMA), Montgomery Depression Rating Scale (MADRS), Sheehan Disability Scale (SDS), visual analogue scale (VAS-PI) and Clinical Global Impression (CGI). Safety assessments included physical examinations, laboratory evaluations, and electrocardiographic findings of adverse events. Assessment time point were evaluated at baseline and 1,2,4,6,8 weeks after starting treatment. Results:After 8 weeks of treatment, the total effective rates of duloxetine group and paroxetine group were 72.0% and 73.1%, respectively, with no significant difference (t=0.465, P=0.612). The clinical curing rates of duloxetine group and paroxetine group were 20.0% and 23.1%, respectively, with no significant difference (t=0.547, P=0.590). The scores of HAMD17, HAMA, MADRS, SDS, VAS-PI and CGI in both groups decreased significantly, with statistical difference between the baseline and other observation time points (P 0.05). The main adverse events of two groups were dry mouth, nausea, dizziness, and stomach discomfort. Conclusion:Duloxetine enteric-coated tablet is an effective antidepressant with less side effects, better safety, and more suitable for the treatment of depression patients
Highlights
Major depressive disorder (MDD) is a highly prevalent condition that is associated with significant levels of disability, morbidity, and mortality; its associated lifetime suicide rate is estimated to be 15%.(1) Antidepressants (ADs) are the first-line treatment for depression
The patients who met any of the following criteria was withdrawn or dropped out the trial: adverse events or abnormal laboratory values determined by the researchers; patient withdrawal from the trial; violation of the study protocol; subjects in the trial process of pregnancy; consent withdrawal, or lack of follow-up
During the 8 weeks of treatment, the scores of anxiety / somatic, cognitive impairment, block and sleep disturbance of Hamilton Depression Rating Scale (HAMD)-17 were similar between the groups, and there was no significant difference between the two groups (P > 0.05)
Summary
Major depressive disorder (MDD) is a highly prevalent condition that is associated with significant levels of disability, morbidity, and mortality; its associated lifetime suicide rate is estimated to be 15%.(1) Antidepressants (ADs) are the first-line treatment for depression. Duloxetine is a new antidepressant for the treatment of MDD It selectively inhibits the uptake of serotonin (5-HT) and norepinephrine (NE) by neurons from the synaptic gap, increases the synaptic pool of available neurotransmitters, and relieves depressive symptoms.[2,3] In vivo and in vitro studies have shown that duloxetine is an effective and balanced inhibitor of 5-HT and NE uptake, with little effect on other neurotransmitter receptors (such as M, a1, a2, dopamine D2, and histamine H1 and H2 receptors).(4,5) The efficacy of duloxetine in reducing depressive symptoms has been demonstrated in patients with MDD,(6) comparable to efficacy to selective 5-HT reuptake inhibitors such as fluoxetine, paroxetine, citalopram, and sertraline.[7,8] Duloxetine has been reported to be effective in the treatment of generalized anxiety disorder,(9) fibromyalgia.[10] Diabetic Peripheral Neuropathic Pain,(11) pathological laughing and crying,(12) and improvement of cognitive function in depression patients.[13] Overall, duloxetine has been well tolerated across all trials.[7,8,14]
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