Depression Treatment Study

Yale Depression Research Program

Principal Investigator

Gerard Sanacora, MD, PhD

Sub-Investigators

Mark Niciu, MD, PhD
Gerald Valentine, MD
Gretchen Hermes, MD, PhD
Madonna Fasula, APRN

Study Staff

Lisa Roach, BA
Elizabeth Cooper, BS

HIC#0903004917

The Yale Depression Research Clinic is conducting a clinical trial for the treatment of major depression. The purpose of this study is to explore the effectiveness of adding Riluzole, a novel medication, to an existing SSRI medication in patients who have not achieved a good response to the standard SSRI antidepressant medication alone.

Riluzole is an FDA approved medication that is currently only indicated for the treatment of Lou Gehrig’s disease. Although there are now several small studies suggesting Riluzole may be effective in treating patients with mood and anxiety disorders that had not previously responded to standard treatments, this is the first large controlled trial of the medication for depression.

Patients who are currently still experiencing depressive symptoms despite having tried up to 3 different medications during the current episode or who are not on medication during this episode may be eligible.

Eligible patients currently taking an approved SSRI medication could begin add-on treatment with study drug immediately. Patients not on an approved medication will initially be started on Citalopram, a standard SSRI antidepressant medication. If after a period of 8 weeks, symptoms continue to meet study criteria, the investigational drug will be added.

Participants will either receive Riluzole or placebo (an inactive “sugar pill”) in addition to their primary SSRI for up to 8 weeks. Participants will be evaluated weekly as outpatients during the study. Participants who complete the 8 week experimental phase of the study may be eligible to receive three months of Riluzole at no cost. However, Riluzole may not be available at no cost after participation in the study has concluded.

Please call the Yale Depression Research Program at 203-764-9131 for further information or to arrange a confidential in-person screening, at no cost or obligation.

Yale Depression Research Program
100 York Street, Suite 2J, New Haven, CT 06511
Telephone: 203-764-9131

For more information about this clinical trial please visit the Yale Research Trials site.

Approved by the Yale University HIC on March 10, 2011