Abstract
BackgroundMajor depressive disorder (MDD) is a chronic and highly disabling condition. Existing pharmacotherapies produce full remission in only 30% to 40% of treated patients. Antidepressants exhibiting dual reuptake inhibition of both serotonin (5-HT) and norepinephrine (NE) may achieve higher rates of remission compared with those acting upon a single neurotransmitter. In this study, the safety and efficacy of duloxetine, a potent dual reuptake inhibitor of 5-HT and NE, were examined.MethodsPatients (N = 533) meeting DSM-IV criteria for MDD received open-label duloxetine (60 mg once a day [QD]) for 12 weeks during the initial phase of a relapse prevention trial. Patients were required to have a 17-item Hamilton Rating Scale for Depression (HAMD17) total score ≥18 and a Clinical Global Impression of Severity (CGI-S) score ≥4 at baseline. Efficacy measures included the HAMD17 total score, HAMD17 subscales, the CGI-S, the Patient Global Impression of Improvement (PGI-I) scale, Visual Analog Scales (VAS) for pain, and the Symptom Questionnaire, Somatic Subscale (SQ-SS). Quality of life was assessed using the Sheehan Disability Scale (SDS) and the Quality of Life in Depression Scale (QLDS). Safety was evaluated by recording spontaneously-reported treatment-emergent adverse events, changes in vital signs and laboratory analytes, and the Patient Global Impression of Sexual Function (PGI-SF) scale.ResultsThe rate of discontinuation due to adverse events was 11.3%. Treatment-emergent adverse events reported by ≥10% duloxetine-treated patients were nausea, headache, dry mouth, somnolence, insomnia, and dizziness. Following 12 weeks of open-label duloxetine therapy, significant improvements were observed in all assessed efficacy and quality of life measures. In assessments of depression severity (HAMD17, CGI-S) the magnitude of symptom improvement continued to increase at each study visit, while for painful physical symptoms the onset of improvement was rapid and reached a maximum after 2 to 3 weeks of treatment.ConclusionIn this open-label phase of a relapse prevention study, duloxetine (60 mg QD) was shown to be safe and effective in the treatment of MDD.Trial registrationNCT00036309.
Highlights
Major depressive disorder (MDD) is a chronic and highly disabling condition
selective serotonin reuptake inhibitors (SSRIs) have not demonstrated superior efficacy when compared with tricyclic antidepressants (TCAs) [5], and up to half of all depressed patients fail to respond to SSRI therapy [6]
The primary outcome of the parent study was an assessment of maintenance of effect of duloxetine 60 mg QD compared with placebo by a comparison of time to relapse among patients who responded to open-label duloxetine treatment
Summary
Major depressive disorder (MDD) is a chronic and highly disabling condition. Antidepressants exhibiting dual reuptake inhibition of both serotonin (5-HT) and norepinephrine (NE) may achieve higher rates of remission compared with those acting upon a single neurotransmitter. Major depressive disorder (MDD) represents one of the most serious challenges faced by healthcare providers throughout the world, affecting some 18 million people in the United States and 340 million people globally [1]. The negative impact of MDD upon patient well-being and functioning is comparable to that of major chronic medical conditions such as diabetes, hypertension, coronary artery disease, and arthritis [2]. Given the enormous impact of depression upon both the individual patient and the healthcare system as a whole, the need for effective treatment is clear. Antidepressant medications, in particular the selective serotonin reuptake inhibitors (SSRIs), currently represent the first line of treatment for MDD. The need for alternative safe and effective treatments for MDD is clear
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