Sertraline Compared With Hypericum Perforatum (St.John's Wort) in Treating Depression

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Wake Forest Cancer Center CCOP Research Base
ClinicalTrials.gov Identifier:
NCT00066859
First received: August 6, 2003
Last updated: April 3, 2013
Last verified: April 2013
  Purpose

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: This randomized phase III trial is studying how well sertraline works compared to St. John's wort in treating mild to moderate depression in patients with solid tumors.


Condition Intervention Phase
Depression
Unspecified Adult Solid Tumor, Protocol Specific
Drug: Zoloft 50 mg
Dietary Supplement: St. John's Wort 600 mg
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Wake Forest Cancer Center CCOP Research Base:

Primary Outcome Measures:
  • Compare the change in depression severity as measured by Hamilton Depression rating scale at 4 months [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    To compare the change in depression severity in cancer patients with mild to moderate depression on sertraline and St. John's wort.


Secondary Outcome Measures:
  • Compare the severity of somnolence, nausea, and insomnia [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Compare Impact of Sertraline and St. John's wort on fatigue [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Correlate the hyperforin concentrations with the change in depression severity [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Enrollment: 2
Study Start Date: March 2004
Study Completion Date: November 2005
Primary Completion Date: April 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1: Sertraline (Zoloft) 50 mg
Zoloft 50 mg by mouth daily for 1 week if tolerated dose may be increased to 100 mg daily for 4 months
Drug: Zoloft 50 mg
Zoloft 50 mg by mouth daily for 1 week if tolerated dose may be increased to 100 mg daily for 4 months
Other Names:
  • Sertraline
  • Zoloft
Active Comparator: Arm 2 - St. John's Wort 600mg
St. John's wort 600 mg daily for 1 week. If tolerated dose may be increased to 900 mg daily for four months.
Dietary Supplement: St. John's Wort 600 mg
St. John's wort 600 mg daily for 1 week, if tolerated. Dose may be increased to 900 mg daily for 4 months.
Other Name: Hypericum perforatum

Detailed Description:

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00066859

Locations
United States, California
Bay Area Tumor Institute
Oakland, California, United States, 94609-3305
United States, Georgia
Regional Radiation Oncology Center at Rome
Rome, Georgia, United States, 30165
United States, Illinois
CCOP - Central Illinois
Decatur, Illinois, United States, 62526
United States, North Carolina
CCOP - Southeast Cancer Control Consortium
Goldsboro, North Carolina, United States, 27534-9479
High Point Regional Hospital
High Point, North Carolina, United States, 27261
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States, 27157-1082
Sponsors and Collaborators
Wake Forest Cancer Center CCOP Research Base
Investigators
Principal Investigator: Antonius A. Miller, MD Comprehensive Cancer Center of Wake Forest University
Study Chair: Edward G. Shaw, MD Comprehensive Cancer Center of Wake Forest University
  More Information

Additional Information:
No publications provided

Responsible Party: Wake Forest Cancer Center CCOP Research Base
ClinicalTrials.gov Identifier: NCT00066859     History of Changes
Other Study ID Numbers: CCCWFU-98101, U10CA081851
Study First Received: August 6, 2003
Last Updated: April 3, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Wake Forest Cancer Center CCOP Research Base:
depression
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mental Disorders
Mood Disorders
Sertraline
Antidepressive Agents
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014