Drug Therapy to Treat Minor Depression
This 6-month study will compare the effectiveness of citalopram (Celexa®), hypericum (St. John's Wort), and placebo for the treatment of minor depression.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
|Official Title:||Pharmacotherapy for Minor Depression|
|Study Start Date:||February 2003|
Minor depression is highly prevalent, causes substantial morbidity and disability, presents a serious risk factor for the development of major depressive disorder, yet is under recognized and under treated. Researchers have determined that patients with minor depression frequently seek treatment from general practitioners and are often treated with prescription antidepressants. There is a need to evaluate the effectiveness of St. John's Wort in the management of minor depression. If the proposed study demonstrates the efficacy of St. John's Wort and/or citalopram, it will suggest treatment paradigms that can be tested and applied in primary care settings.
Patients who meet screening criteria enter a 2-week washout period (or, for fluoxetine, a 4-week washout period) during which no psychotropic medication is permitted. Participants are then randomly assigned to St. John's Wort, citalopram, or placebo for 12 weeks. Participants who respond to treatment by Week 12 continue to take their originally assigned double-blind medication for up to 26 weeks. At Week 12, nonresponders to placebo are crossed over to 1 of the 2 active treatments. Patients who remain nonresponders to that active treatment are crossed over to the alternative active treatment, with the investigator maintaining blind status. Participants have study visits at screening, during the washout period, at baseline, and every 2 weeks thereafter for the course of the study. At the screening visit, Week 12, and Week 20, patients undergo a complete blood count with differential and other routine laboratory tests.
|United States, California|
|Cedars-Sinai Medical Center|
|Los Angeles, California, United States, 90048|
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|United States, Pennsylvania|
|University of Pittsburgh, Western Psychiatric Institute and Clinic|
|Pittsburgh, Pennsylvania, United States|
|Principal Investigator:||Andrew A. Nierenberg|