Dual reuptake inhibitor duloxetine produces rapid and sustained improvement in depression

Use of duloxetine, a reuptake inhibitor of serotonin and norepinephrine, produced rapid and sustained improvement in the symptoms of depression, according to study findings presented at the U.S. Psychiatric and Mental Health Congress.

Data indicate that patients treated with duloxetine 60 mg daily had significantly greater improvement in measures of mood and anxiety than placebo-treated patients by the end of the first week of therapy, with improvements sustained through the end of the nine-week, double-blind trial of patients with major depressive disorder.

In addition, data from a one-year open-label study indicate that 79 percent of patients achieved response and 69 percent of patients achieved remission with doses of either 80 mg daily or 120 mg daily. The drug appears to be relatively well tolerated and safe for long-term treatment over the range of doses studied.
Researchers, who were supported by the drug manufacturer, used several measures for symptoms of depression such as mood and anxiety, including the Hamilton Depression Rating Scale (HAMD-17), Hamilton Anxiety Sub-Scale, Clinical Global Impression Scale of Severity, and Patient Global Impression of Improvement Scale.

"Rapid response to treatment helps doctors recognize that a therapy may be the right one for the patient, but even more importantly if the patient is able to feel improvement quickly, the more likely that patient will stick with treatment and ultimately get well," said Stephen K. Brannan, M.D., presenter.

Many experts believe treatment of the complete spectrum of depression symptoms is intrinsic to a lasting recovery. Combined action through serotonin and norepinephrine may provide a more rapid and sustained clinical effect. Duloxetine is a dual reuptake inhibitor of both serotonin and norepinephrine.
Additional data from the one-year study reflected a low level of adverse drug effects. For instance, discontinuation due to adverse events was relatively low, at 17 percent over the course of the study. Most adverse events occurred early in treatment and were mild to moderate. The only adverse events that occurred at a rate higher than 1.0 percent and led to discontinuation were nausea (1.5%) and somnolence (1.4%). At the end of the year, the mean change in weight from baseline was an increase of 1.1 kg.
Adverse events that occurred at a rate of 3.0 percent or greater upon abrupt discontinuation of drug at the end of the study were dizziness (8.3%), anxiety (4.3%), and nausea (4.2%).
The researchers used pooled analysis for patient data from two nine-week, double-blind, placebo-controlled studies in patients diagnosed with major depressive disorder: A total of 512 patients were randomized to placebo (n=261) or duloxetine 60 mg daily (n=251). Results were evaluated using the Hamilton Depression Rating Scale, as well as the Clinical Global Impression and Patient Global Impression scales.

Additional data were obtained from an open-label, 52-week, international clinical trial involving 1,279 patients who met the criteria for major depressive disorder. These patients received either duloxetine 80 mg/day or 120 mg/day. Efficacy was measured with the use of the same three scales.





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