A Phase III Double-Blind Randomized Trial Comparing Sertraline (Zoloft) And Hypericum Perforatum (St. John's Wort) In Cancer Patients With Mild To Moderate Depression
- Compare the change in depression severity in cancer patients with mild to moderate
depression treated with sertraline vs Hypericum perforatum.
- Compare the severity of somnolence, nausea, and insomnia in patients treated with these
- Compare the impact of these regimens on fatigue in these patients.
- Correlate hyperforin concentrations with change in depression severity in patients
treated with Hypericum perforatum.
OUTLINE: This is a randomized, double-blind study. Patients are stratified according to
level of depression (mild vs moderate), concurrent radiotherapy (yes vs no), and TNM stage
(I, II, or III vs IV). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral sertraline daily.
- Arm II: Patients receive oral Hypericum perforatum daily. In both arms, treatment
continues for 4 months in the absence of unacceptable toxicity.
Measurements of depression, somnolence, nausea, insomnia, fatigue, and hyperforin
concentration are assessed at baseline, and at 1, 2, and 4 months.
PROJECTED ACCRUAL: A maximum of 250 patients will be accrued for this study.
Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
Compare the change in depression severity as measured by Hamilton Depression rating scale at 4 months
To compare the change in depression severity in cancer patients with mild to moderate depression on sertraline and St. John's wort.
Antonius A. Miller, MD
Comprehensive Cancer Center of Wake Forest University
United States: Institutional Review Board
|CCOP - Southeast Cancer Control Consortium||Winston-Salem, North Carolina 27104-4241|
|Comprehensive Cancer Center at Wake Forest University||Winston-Salem, North Carolina 27157-1082|
|CCOP - Central Illinois||Springfield, Illinois 62526|
|Regional Radiation Oncology Center at Rome||Rome, Georgia 30165|
|Bay Area Tumor Institute||Oakland, California 94609|
|High Point Regional Hospital||High Point, North Carolina 27261|