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Sertraline Compared With Hypericum Perforatum (St. John's Wort) in Treating Mild to Moderate Depression in Patients With Cancer Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on Sertraline Compared With Hypericum Perforatum (St. John's Wort) in Treating Mild to Moderate Depression in Patients With Cancer conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Sertraline Compared With Hypericum Perforatum (St. John's Wort) in Treating Mild to Moderate Depression in Patients With Cancer Clinical research trials and Sertraline Compared With Hypericum Perforatum (St. John's Wort) in Treating Mild to Moderate Depression in Patients With Cancer medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like Sertraline Compared With Hypericum Perforatum (St. John's Wort) in Treating Mild to Moderate Depression in Patients With Cancer. Sertraline Compared With Hypericum Perforatum (St. John's Wort) in Treating Mild to Moderate Depression in Patients With Cancer Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a Sertraline Compared With Hypericum Perforatum (St. John's Wort) in Treating Mild to Moderate Depression in Patients With Cancer clinical trial. Subjects typically recieve the finest healthcare available for their Sertraline Compared With Hypericum Perforatum (St. John's Wort) in Treating Mild to Moderate Depression in Patients With Cancer condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
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Home > "S" Clinical Trials Conditions > Sertraline Compared With Hypericum Perforatum (St. John's Wort) in Treating Mild to Moderate Depression in Patients With Cancer  Sertraline Compared With Hypericum Perforatum (St. John's Wort) in Treating Mild to Moderate Depression in Patients With Cancer
Sertraline Compared With Hypericum Perforatum (St. John's Wort) in Treating Mild to Moderate Depression in Patients With Cancer
For Condition: unspecified adult solid tumor, protocol specific,Depression
Status: Recruiting
Sponsor(s): Comprehensive Cancer Center of Wake Forest University , National Cancer Institute (NCI)
Synopsis: RATIONALE: Antidepressants such as sertraline and the herb hypericum perforatum (St. John's wort) may be effective in treating mild to moderate depression. It is not yet known which treatment is more effective in improving depression in patients who have cancer. PURPOSE: Randomizedphase III trial to compare the effectiveness of sertraline with that of St. John's wort in treating mild to moderate depression in patients who have solid tumors.
Details: OBJECTIVES: - 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 regimens. - 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed solid tumor - No hematologic malignancy (e.g., leukemia, lymphoma, or multiple myeloma) - Diagnosis of mild to moderate depression - No severe depression or suicidal ideation - No psychotic symptoms, dementia, or marked agitation requiring medication - No brain metastases or primary brain tumor PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-1 Life expectancy - More than 4 months Hematopoietic - Hemoglobin greater than 10 g/dL Hepatic - Bilirubin no greater than 1.5 mg/dL Renal - Not specified Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No prior or concurrent alcohol abuse or drug dependence PRIOR CONCURRENT THERAPY: Biologic therapy - No concurrent epoetin alfa (e.g., Procrit® or Aranesp®) Chemotherapy - At least 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) - No concurrent chemotherapy Endocrine therapy - No concurrent corticosteroids Radiotherapy - Prior or concurrent radiotherapy allowed except brain irradiation for brain metastases or primary brain tumor Surgery - Not specified Other - More than 4 weeks since prior antidepressants or Hypericum perforatum - No concurrent warfarin (central line prophylaxis allowed) - No concurrent administration of any of the following: - Theophylline - Protease inhibitors used to treat AIDS - Digoxin - Cyclosporine - Benzodiazepines (e.g., diazepam or alprazolam) - Calcium-channel blockers (e.g., diltiazem or nifedipine) - Coenzyme A reductase inhibitors (cholesterol-lowering agents) - Macrolide antibiotics (e.g., azithromycin, erythromycin, or clarithromycin) - Griseofulvin - Phenobarbital - Phenytoin - Rifampin - Rifabutin - Ketoconazole - Fluconazole - Itraconazole - Grapefruit juice - Naturopathic/herbal products that would interfere with Hypericum perforatum
Total Enrollment:
Location and Contact Information:
Overall Study Official:
W.McCall, , Comprehensive Cancer Center of Wake Forest University
Regional Radiation Oncology Center at Rome *Recruiting*
Rome, Georgia, 30165
United States
Recruiting M.P. Mumber 706-234-1400
CCOP - Greenville *Recruiting*
Greenville, South Carolina, 29615
United States
Recruiting Jeffrey Giguere 864-241-6251
CCOP - Western Regional, Arizona *Recruiting*
Phoenix, Arizona, 85006-2726
United States
Recruiting David King 602-258-4875
CCOP - Central Illinois *Recruiting*
Decatur, Illinois, 62526
United States
Recruiting James Wade 217-876-6617
CCOP - Upstate Carolina *Recruiting*
Spartanburg, South Carolina, 29303
United States
Recruiting James Bearden 864-560-7050
Comprehensive Cancer Center at Wake Forest University *Recruiting*
Winston Salem, North Carolina, 27157-1082
United States
Recruiting Antonius Miller 336-713-4392
Leo W. Jenkins Cancer Center of University Health Systems of Eastern Carolina *Recruiting*
Greenville, North Carolina, 27858-4354
United States
Recruiting Ron Allison 252-744-2900
Alamance Cancer Center *Recruiting*
Burlington, North Carolina, 27216
United States
Recruiting Geoffrey Browne 336-538-7445
CCOP - Southeast Cancer Control Consortium *Recruiting*
Winston Salem, North Carolina, 27104-4241
United States
Recruiting James Atkins 336-777-3036
High Point Regional Hospital *Recruiting*
High Point, North Carolina, 27261
United States
Recruiting Bernard Chinnasami 336-878-6924
Additional Information:
Study ID Numbers: CDR0000320508; CCCWFU-98101,CCCWFU-BGOI-152
Study Start Date:
Record last reviewed: August 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00066859
Other Depression Studies:
1. Study of Health Promotion in Patients With Early-Stage Breast or Prostate Cancer
2. Sertraline for Alcohol Dependence and Depression
3. Reducing Symptoms of Depression in Low-Income Mothers
4. Preventing Post-Stroke Depression
5. Combination Chemotherapy Plus Fluoxetine in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer
Related Studies:
Other Depression Clinical Trials
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Sertraline Compared With Hypericum Perforatum (St. John's Wort) in Treating Mild to Moderate Depression in Patients With Cancer
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