Sharon Hanks
Pine Rest Christian Mental Health Services is seeking patients who suffer with major depressive disorder to voluntarily participate in a study that will evaluate the long-term safety and tolerability of a new drug.
LeAnn Smart, Pine Rest research coordinator, says the Cutlerville-based organization is hoping to enroll 10 patients by mid-September for a year-long clinical trial of the medication, reportedly agomelatine, joining 45 other organizations nationwide who are participating in the study.
Smart says the open label study hopes to enroll a total of 800 patients. An open label study means all men and women will take the same drug, not placebos, and will not be randomized into treatment groups.
The drug, for which Novartis Pharmaceuticals reportedly holds the U.S. market rights, is described by Pine Rest officials as a new antidepressant with a distinct neurochemical profile -- it binds to both melatonin and serotonin receptors in the brain. This phase-three clinical trial is expected to help patients suffering with both symptoms of depression and insomnia.
"We're very excited to have the opportunity to collaborate with organizations that are looking for new treatments for various mental health diagnoses," Smart says. "There are a whole lot of antidepressants on the market, but not everyone responds to the medication in the same way, so some will have a lot of success (with a drug) and others won't. Everybody is unique so the response is different for everybody."
To participate in the study, one should be between ages 18 to 70 and be in relatively good health with a diagnosis of MDD. A participant can be taking other medications except fluvoxamine. Female patients cannot be pregnant and must be willing to use effective contraception. All patients will be expected to attend 12 appointments in Cutlerville throughout the 52-week trial period.
Smart believes this is the first clinical trial Pine Rest has participated in involving an investigative drug. "Our research department is fairly new," she says.
Psychiatrists Eric Achtyes, MD, and Gilbert Masterson, MD, are the co-investigators of the Pine Rest study. To enroll, contact Smart at 616-281-6363, ext. 2191.
Pine Rest is one of the nation's five largest free-standing behavioral health providers to provide a full continuum of services, including addiction treatment and recovery, extensive child and adolescent programs, senior care services and eletroconvulsive therapy. In addition to its main campus, Pine Rest also has 16 outpatient locations throughout West Michigan and two in Iowa.
Source: LeAnn Smart, research coordinator at Pine Rest Christian Mental Health Services
Sharon Hanks is innovations and jobs news editor at Rapid Growth Media. Please send story ideas and comments for the column to Sharon at [email protected]. She also is owner of The Write Words in Grand Rapids.
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