SPRI Clinical Trials Now Enrolling Patients For Study Of New Treatment For Depression

Main Category: Depression
Also Included In: Psychology / Psychiatry;  Mental Health;  Clinical Trials / Drug Trials
Article Date: 16 Oct 2007 - 0:00 PDT

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SPRI Clinical Trials announced that it is now screening patients for enrollment in the parAGOn Clinical Trial Program, which will start with two Phase III studies to evaluate the efficacy, safety and tolerability of agomelatine, a novel, investigational, once-daily medication for the treatment of Major Depressive Disorder (MDD). The 8-week, randomized, placebo-controlled studies are sponsored by Novartis Pharmaceuticals Corporation, and each of the two Phase III studies will include 490 patients from approximately 50 centers.

This investigational new drug targets both melatonin receptors and serotonin (5-HT2c) receptors.

The parAGOn Clinical Trial Program is open to patients between the ages of 18 and 70 who are experiencing MDD and meet other eligibility criteria. Eligible patients will be equally randomized to receive either treatment with agomelatine 25 mg, agomelatine 50 mg or placebo once daily for 8 weeks. Patients who complete the eight-week double-blind treatment phase may also participate in a 52-week open-label extension of the study.

MDD is the most common mood disorder, affecting approximately 15 million American adults, according to the National Alliance on Mental Illness. Common symptoms include: depressed mood, loss of interest in daily activities, poor concentration, weight loss (or gain), decrease of appetite, sleep disturbance, feelings of worthlessness and /or of guilt, and suicidal ideation. Episodes of depression may be chronic and recurrent, according to the National Institute of Mental Health.

SPRI Clinical Trials
http://www.spristudy.com

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