Severe Depressive Episode Study

Principal Investigator: William Fuller, MD

Study Coordinator: Christi Hinker, RNC

Sub-Investigators: Grace A. LaFollette, APRN, BC; Susan E. Weaver, CNP; Julie M. Kittelsrud, CNP; Gail Fuller, RN

Study Description: A 12-Week Randomized, Open-Label Trial of Duloxetine Versus Generic SSRIs in the Treatment of a Severe Depressive Episode

Overview: Major depressive disorder is a common psychiatric illness consisting of one or more major depressive episodes in which individuals experience a predominantly sad mood in addition to a variety of other symptoms that may cause distress and an inability to perform everyday functions.

The purpose of this clinical drug study is to compare the effectiveness and safety of an investigational medication to that of four other medications currently used to manage major depressive disorder. Participation in this study would be expected to last up to 15 weeks.

Participants in this research study will receive the following, at no cost: study-related medication, vital signs measurements, physical examination, and laboratory evaluations.

Inclusion Criteria:

• Men and women aged 18 and older
• Meet the criteria for Major Depressive Disorder, based on diagnostic criteria
• Agree to keep scheduled appointments for clinic visits, tests, and procedures required by the plan of the study

Exclusion Criteria:

• Women who are pregnant, breastfeeding or planning to become pregnant
• History of bipolar disorder, a primary psychotic disorder (schizophrenia, schizophreniform disorder, schizoaffective disorder, delusional disorder), a cognitive disorder, or obsessive-compulsive disorder
• Clinically considered to be at serious suicidal risk or have a history of recurrent self-mutilation or self-harm
• Moderate to severe dementia
• History of substance abuse or dependence within the past 6 months, excluding nicotine and caffeine

Contact:  Christi Hinker, RNC
Phone:  (605) 322-3084
Email:    christi.hinker@mckennan.org