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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


Phase 3
18 Years
N/A
Not Enrolling
Both
Depression, Unspecified Adult Solid Tumor, Protocol Specific

Thank you

Trial Information

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


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.

Inclusion Criteria


INCLUSION CRITERIA:

- Mild or moderate depression as determined by the following criteria (see Section 7.1
and 8.0)

- Mild : HRSD score 10-14; moderate: HRSD score 15-19 (Appendix IV)

- At least 2 of nine symptoms of depression on the PHQ (Appendix V)

- At least one of the nine PHQ symptoms must be either depressed/irritable mood or
anhedonia

- Histologically or cytologically documented solid tumor, lymphoma, or primary or
metastatic brain tumor > 6 months from radiation with stable disease or no evidence
of disease.

- Concurrent cancer chemotherapy with sertraline or St. John's wort is not allowed,
therefore patients must have no plan for chemotherapy for 4 months

- Prior chemotherapy is allowed, but patients must be >4 weeks from prior chemotherapy
except >6 weeks from prior mitomycin-C or nitrosourea

- Patients receiving Rituxin, Herceptin, Erbitux, Interferon, etc. are eligibile for
this study while under treatment.

- Prior or concurrent radiation is allowed except brain irradiation for brain
metastases or primary brain tumor. Must be > 6 months from radiation with stable
disease or no evidence of disease.

- Age > 18 years

- ECOG performance status 0 -1 (Appendix III)

- Life expectancy >4 months

- Required initial laboratory values (within 3 days of registration): hemoglobin >10
g/dl and bilirubin <1.5 mg/dl, negative pregnancy test

- Signed protocol specific informed consent prior to registration

- Patient recruitment this study will be done through the out patient clinic. The
research PI or designee including clinic physician, resident, research nurse or
research assistant will review medical information to determine or verify protocol
eligibility either at the time the patient is being seen in the clinic for a routine
visit/consult or prior to the patient's clinic visit.

EXCLUSION CRITERIA:

- A patient will be excluded if he/she is (a) judged to be severely depressed using the
following criteria: HRSD score 20 or more or a positive score on PHQ item i (suicidal
ideation) or (b) judged not to be depressed by a score of 9 or less on the HRSD or
fewer than two PHQ items scored positively. A patient who is found to be severely
depressed or suicidal, either on initial screening or during the trial will be
referred for appropriate treatment.

- Psychotic symptoms, dementia, marked agitation requiring medication

- Current or previous alcohol or drug dependence

- Hematologic malignancy (i.e., leukemias, multiple myeloma)

- Planned chemotherapy in the next 4 months

- Antidepressant or St. John's wort use in the last 4 weeks

- Current or planned use of erythropoietin (Procrit®, Aranesp®)

- Current or planned use of theophylline, warfarin (except for central line
prophylaxis), protease inhibitors used to treat AIDS, digoxin, cyclosporin,
benzodiazepines (such as diazepam, alprazolam, etc), calcium-channel blockers (such
as diltiazem, nifedipine, etc), coenzyme A reductase inhibitors (cholesterol lowering
agents), macrolide antibiotics (such as azithromycin, erythromycin, clarithromycin,
etc), griseofulvin, phenobarbital, phenytoin, rifampin, rifabutin, ketoconazole,
fluconazole, itraconazole, corticosteroids, grapefruit juice, or other
naturopathic/herbal products that could interfere with St. John's wort (call study
chairman with questions).

- Pregnant or nursing women

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Outcome Measure:

Compare the change in depression severity as measured by Hamilton Depression rating scale at 4 months

Outcome Description:

To compare the change in depression severity in cancer patients with mild to moderate depression on sertraline and St. John's wort.

Outcome Time Frame:

4 months

Safety Issue:

No

Principal Investigator

Antonius A. Miller, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Comprehensive Cancer Center of Wake Forest University

Authority:

United States: Institutional Review Board

Study ID:

CCCWFU-98101

NCT ID:

NCT00066859

Start Date:

March 2004

Completion Date:

November 2005

Related Keywords:

  • Depression
  • Unspecified Adult Solid Tumor, Protocol Specific
  • depression
  • unspecified adult solid tumor, protocol specific
  • Depression
  • Depressive Disorder

Name

Location

CCOP - Southeast Cancer Control ConsortiumWinston-Salem, North Carolina  27104-4241
Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082
CCOP - Central IllinoisSpringfield, Illinois  62526
Regional Radiation Oncology Center at RomeRome, Georgia  30165
Bay Area Tumor InstituteOakland, California  94609
High Point Regional HospitalHigh Point, North Carolina  27261