Pine Rest, along with 45 other organizations, will conduct an open label study for patients with major depressive disorder (MDD).
This Phase 3, open label study is designed to evaluate the long term safety and tolerability of the study drug administered as tablets in adult patients with MDD. It is a new antidepressant with a distinct neurochemical profile, binding to both melatonin and serotonin receptors in the brain. It should help patients suffering with both symptoms of depression and insomnia.
An open label study means that all patients will take the study drug, not placebos, and patients are not randomized into treatment groups. Several health factors will be assessed regularly, including blood tests for liver function, during the 52-week treatment period.
Participant Criteria for Study Male or female, 18 – 70 years of age; In relatively good health with a diagnosis of MDD, moderate to severe;Female patients cannot be pregnant and must be willing to use effective contraception;Patients can be taking other medications, except fluvoxamine;Other factors to be reviewed in introductory interview.
Psychiatrists Eric Achtyes, MD, and Gilbert Masterson, MD, are the co-investigators of the Pine Rest study. “There is a narrow recruitment window beginning now until September 10,” says Dr. Achtyes.
More information is available through the Pine Rest Research Coordinator, LeAnn Smart. She can be reached at 616-281-6363 ext. 2191 or through e-mail at email@example.com.