CINCINNATI—Researchers at the University of Cincinnati (UC)
are participating in a multicenter clinical research study of a new investigational
medication for patients with major depressive disorder who have not responded
to existing antidepressants.
This investigational medicine was discovered and is being
developed by AstraZeneca Pharmaceuticals. AstraZeneca is also sponsoring the
The trial represents a new approach to treatment of
depression by targeting a brain chemical called glutamate, which may be
increased in patients with depression.
UC is one of 60 study locations for the new trial, in which
the medication is administered intravenously. The principal investigator at UC is
Erik Nelson, MD, with co-investigator Lesley Arnold, MD, both of whom are
faculty members in the UC Department of Psychiatry and Behavioral Neuroscience
and clinicians with UC Health Psychiatry. Arnold is also director of the
Women’s Health Research Program at UC.
"The most commonly used antidepressants work by increasing
other neurotransmitters, such as serotonin and norepinephrine,” says Nelson. "But
not everyone with depression responds to those medications.
"To be included in this clinical trial, patients with a
clinical diagnosis of major depressive disorder must have a lifetime history of
inadequate response to at least three antidepressant medications.”
While the study is open to both men and women aged 18 to 70,
Arnold notes that men and women respond differently to medications used for
treating depression. "This underlines the importance of testing new
investigational drugs for depression,” she says.
Patients ineligible for the study include those diagnosed
with bipolar disorder or schizophrenia; who have had a suicide attempt within
the past six months; who have any history of seizure disorder; and who are
pregnant or lactating. Other study eligibility criteria are available at
In this study, neither the patients nor the investigators
will know whether the investigational medication or placebo is being delivered.
Patients will receive either the study drug or placebo added to ongoing treatment
with their antidepressant medication over a period of 12 weeks. Total
involvement may last up to 26 weeks. The study is expected to complete enrollment
by April 2013.
Arnold report no conflicts of interest with AstraZeneca.