This is a resubmission of a three-site, four-year study to assess the efficacy of St. John's Wort (SJW), standardized to hyperforin content, and citalopram, compared to placebo for the treatment of Minor Depression (MinorD). The proposal differs from the first submission and from ongoing studies of SJW for major depression, in that it: focuses in MinorD only; includes the use of SJW standardized to hyperforin, a more potent formulation; has a refined set of primary and secondary aims; uses a continuous measure of efficacy as the primary outcome of the study; uses random regression models for data analysis; and includes a cross-over phase for non-responders. MinorD has major effects. Patients with MinorD experience substantial morbidity, distress, and dysfunction; even so, less than 10 percent of patients with MinorD receive formal treatment. Many choose to self-medicate with SJW, an untested treatment for MinorD that generates over $200 million a year in sales. We propose to randomize 300 subjects to double-blind flexible doses of SJW up to 1800 mg/day, or citalopram up to 60 mg/day, or placebo, for 12 weeks. At 12 weeks, nonresponders will be crossed-over to active treatment arms previously unassigned; responders will continue to take study medication for another 12 weeks. Stringent criteria will be used to assess improvement in symptoms, dysfunction, and improvement in well-being. The results of this study will have profound public health implications by improving our understanding of the efficacy of SJW and standard antidepressants for the treatment of MinorD.

Agency
National Institute of Health (NIH)
Institute
National Institute of Mental Health (NIMH)
Type
Research Project (R01)
Project #
1R01MH061758-01A2
Application #
6384217
Study Section
Special Emphasis Panel (ZMH1-CRB-X (02))
Program Officer
Rudorfer, Matthew V
Project Start
2001-09-17
Project End
2005-08-31
Budget Start
2001-09-17
Budget End
2002-08-31
Support Year
1
Fiscal Year
2001
Total Cost
$384,417
Indirect Cost
Name
Massachusetts General Hospital
Department
Type
DUNS #
City
Boston
State
MA
Country
United States
Zip Code
02199
Nierenberg, Andrew A; Rapaport, Mark Hyman; Schettler, Pamela J et al. (2010) Deficits in psychological well-being and quality-of-life in minor depression: implications for DSM-V. CNS Neurosci Ther 16:208-16