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Results of phase III study on Labopharm's novel antidepressant published in Psychiatry (Edgemont) Journal
Date:5/19/2009

ts with major unipolar depressive disorder (MDD).

The results of primary efficacy end point analyses demonstrated consistent statistical superiority of Labopharm's trazodone formulation over placebo. Moreover, statistically significant improvements were demonstrated on several secondary efficacy end points, including Hamilton Rating Scale for Depression (HAMD-17) responders, Montgomery-Asberg Depression Rating Scale (MADRS) score, and quality of sleep.

The authors emphasize the clinical importance of targeting sleep improvement in patients with MDD, which is reported in more than 90% of cases. Patients receiving Labopharm's trazodone formulation demonstrated significant improvements versus placebo in all three quality of sleep end points, with an improvement by the first week of therapy in "overall quality of sleep" and "awakening during the night".

Agitation is a common symptom of MDD and patients taking antidepressants often experience an exacerbation of this symptom. In the study, those administered Labopharm's trazodone formulation showed no increase in agitation.

The results of the study demonstrate Labopharm's once-daily trazodone may have a early onset of action. The overall antidepressant efficacy of Labopharm's trazodone formulation was accompanied by improvements early in the study, including an early improvement in HAMD-17 scores, which suggest that patients may see clinical benefit within the first 2 weeks of treatment, and a significantly greater number of HAMD-17 responders than placebo by the end of titration.

Adverse events of particular concern in the treatment of MDD are those related to weight gain and sexual dysfunction, as they are among the most prevalent reasons for discontinuation of antidepressant therapy. In the study, there were no significant changes in body weight in either those administered Labopharm's trazodone formulation or those administered placebo and there was a low incidence of sexual dy
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SOURCE Labopharm Inc.
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