Researchers Study New Investigational Medication for Depression

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 trial.

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 clinicaltrials.gov.

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.

Nelson and Arnold report no conflicts of interest with AstraZeneca.