Researchers led by John Rush, MD, Betty Jo Hay distinguished chair in mental health, Rosewood Corporation chair in biomedical science, and professor of psychiatry, University of Texas Southwestern Medical Center, Dallas, Texas, enrolled 267 patients with a Diagnostic and Statistical Manual - Revision IV diagnosis of major depressive disorder. Treatment was either 300 to 450 mg of bupropion or placebo.

Study subjects were a mean age of 40 years (range 19-69), just over two thirds were female, and 77% were Caucasian.

According to the physician rating of depression, 50% of subjects in the bupropion arm had a response to treatment compared to 32% of those on placebo (P < .01). Response was defined as a reduction of more than 50% in the total score compared with baseline.

There was no statistical difference in self-rated response rates (39% and 50%, respectively; P = .084).

Remission was regarded as a total self rated IDS score < 15, and a clinician-rated total score of < 13. Self-rated remission rates over 8 weeks were significantly better in the bupropion than the placebo arm (40% vs 25%; P < .01). The difference in remission rates was greater when rated by clinicians (32% for bupropion, 19% for placebo; P < .005).

At the end of 8 weeks, the researchers observed a significant improvement in energy, pleasure, and interest compared with baseline in the bupropion arm compared with the placebo arm, as rated both by the patients (P < .0007) and clinicians (P < .001).

Similarly, there were improvements in self-rated and clinician-rated scores of insomnia (P = .023 and P = .008, respectively).

There was no difference in the improvements to anxiety scores between bupropion and placebo.

According to previously reported research, 73% of patients with major depression have listlessness, feel tired and have no energy.

The researchers said that bupropion was generally well tolerated. However 12 bupropion-treated patients withdrew prematurely from the study because of adverse events, compared with 3 in the placebo group.

There were more complaints of dry mouth, dizziness, nausea, insomnia, anxiety, dyspepsia sinusitis, and tremor in those treated with bupropion compared with those on placebo. Those in the bupropion group reported a mean weight loss of 1.1kg, while those on placebo gained a mean 0.2 kg, a significant difference (P = .05).

There were slightly more sustained changes in blood pressure in the bupropion compared with the placebo group. Eight patients in the bupropion group and 3 in the placebo group had heart rate increases of more than 10 BPM compared with baseline at 3 successive clinic visits.

GlaxoSmithKline, Research Triangle Park, North Carolina, provided funding for this study.

Citation: Journal of the European College of Neuropsychopharmacology. 2005;15 (suppl 3):S450.

REFERENCE:
Tylee A, Gastpar M, Lepine JP, et al. DEPRES II (Depression Research in European Society II): a patient survey of the symptoms, disability and current management of depression in the community. Inter Clin Psychopharmacol. 1999;14:139:151.


[Presentation title: Bupropion for the Treatment of Major Depressive Disorder Characterized by Loss of Pleasure, Interest and Energy. Abstract: P.2.134]

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