This contract will be to conduct a three-arm, placebo controlled, clinical efficacy study of a standardized extract of hypericum in major depression. The trial is designed specifically to test the reported acute efficacy and safety of hypericum, in DSM-IV major depression in comparison to placebo. A third treatment group, using a selective serotonin re-uptake inhibitor (SSRI), will be included to ensure the validity of the trial. In addition, the design includes a four month follow-up period to monitor longer term effects. It is anticipated that 336 subjects (112 in each arm) will participate in the study and will be enrolled over an 18 month period. Efficacy will be evaluated at 8 weeks (acute efficacy); those responding to treatment will continue for an additional 18 weeks (maintenance). The results of the study will be presented to the advisory Councils of both the Office of Alternative Medicine (OAM) and the NIMH as well as at the annual New Clinical Drug Evaluation Unit (NCDEU) meeting and will be submitted for publication in scientific journals. Details of the study design, including patient entry criteria, randomization procedures and analysis are included in the study protocol. The contractor will be responsible for central coordination of the trial including recruiting clinical sites, finalizing the study design, preparing informed consent documents, providing data forms, training, centralized communication, data entry and management and quality control, as well as statistical analysis, report writing and other related activities. This project will involve a multi center effort and a collaborative relationship with clinical site investigators, and NIMH staff.

Agency
National Institute of Health (NIH)
Institute
National Institute of Mental Health (NIMH)
Type
Research and Development Contracts (N01)
Project #
N01MH070007-001
Application #
2862384
Study Section
Project Start
1997-09-30
Project End
2000-09-30
Budget Start
1998-08-12
Budget End
1999-09-30
Support Year
Fiscal Year
1998
Total Cost
Indirect Cost
Name
Duke University
Department
Psychiatry
Type
Schools of Medicine
DUNS #
071723621
City
Durham
State
NC
Country
United States
Zip Code
27705
Chen, Justin A; Vijapura, Sagar; Papakostas, George I et al. (2015) Association between physician beliefs regarding assigned treatment and clinical response: re-analysis of data from the Hypericum Depression Trial Study Group. Asian J Psychiatr 13:23-9
Grobler, Anneke C; Matthews, Glenda; Molenberghs, Geert (2014) The impact of missing data on clinical trials: a re-analysis of a placebo controlled trial of Hypericum perforatum (St Johns wort) and sertraline in major depressive disorder. Psychopharmacology (Berl) 231:1987-99
Sarris, J; Fava, M; Schweitzer, I et al. (2012) St John's wort (Hypericum perforatum) versus sertraline and placebo in major depressive disorder: continuation data from a 26-week RCT. Pharmacopsychiatry 45:275-8
Bitran, Stella; Farabaugh, Amy H; Ameral, Victoria E et al. (2011) Do early changes in the HAM-D-17 anxiety/somatization factor items affect the treatment outcome among depressed outpatients? Comparison of two controlled trials of St John's wort (Hypericum perforatum) versus a SSRI. Int Clin Psychopharmacol 26:206-12
Chen, Justin A; Papakostas, George I; Youn, Soo Jeong et al. (2011) Association between patient beliefs regarding assigned treatment and clinical response: reanalysis of data from the Hypericum Depression Trial Study Group. J Clin Psychiatry 72:1669-76
Vitiello, Benedetto; Shader, Richard I; Parker, Corette B et al. (2005) Hyperforin plasma level as a marker of treatment adherence in the National Institutes of Health Hypericum Depression Trial. J Clin Psychopharmacol 25:243-9