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

Primary Purpose

Depression, Unspecified Adult Solid Tumor, Protocol Specific

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Zoloft 50 mg
St. John's Wort 600 mg
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Depression focused on measuring depression, unspecified adult solid tumor, protocol specific

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Bay Area Tumor Institute
  • Regional Radiation Oncology Center at Rome
  • CCOP - Central Illinois
  • CCOP - Southeast Cancer Control Consortium
  • High Point Regional Hospital
  • Comprehensive Cancer Center at Wake Forest University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Arm 1: Sertraline (Zoloft) 50 mg

Arm 2 - St. John's Wort 600mg

Arm Description

Zoloft 50 mg by mouth daily for 1 week if tolerated dose may be increased to 100 mg daily for 4 months

St. John's wort 600 mg daily for 1 week. If tolerated dose may be increased to 900 mg daily for four months.

Outcomes

Primary Outcome Measures

Depression severity as measured by Hamilton Depression rating scale.
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

Somnolence, nausea, and insomnia as assessed by the NCI Common Toxicity Criteria. The Epworth Sleepiness Scale will also be used to assess somnolence.
Fatigue as measured by the Functional Assessment of Chronic Illness Therapy-Fatigue Scale.

Full Information

First Posted
August 6, 2003
Last Updated
September 7, 2021
Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00066859
Brief Title
Sertraline Compared With Hypericum Perforatum (St.John's Wort) in Treating Depression
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
March 1, 2004 (undefined)
Primary Completion Date
April 1, 2005 (Actual)
Study Completion Date
November 1, 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Unspecified Adult Solid Tumor, Protocol Specific
Keywords
depression, unspecified adult solid tumor, protocol specific

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1: Sertraline (Zoloft) 50 mg
Arm Type
Active Comparator
Arm Description
Zoloft 50 mg by mouth daily for 1 week if tolerated dose may be increased to 100 mg daily for 4 months
Arm Title
Arm 2 - St. John's Wort 600mg
Arm Type
Active Comparator
Arm Description
St. John's wort 600 mg daily for 1 week. If tolerated dose may be increased to 900 mg daily for four months.
Intervention Type
Drug
Intervention Name(s)
Zoloft 50 mg
Other Intervention Name(s)
Sertraline, Zoloft
Intervention Description
Zoloft 50 mg by mouth daily for 1 week if tolerated dose may be increased to 100 mg daily for 4 months
Intervention Type
Dietary Supplement
Intervention Name(s)
St. John's Wort 600 mg
Other Intervention Name(s)
Hypericum perforatum
Intervention Description
St. John's wort 600 mg daily for 1 week, if tolerated. Dose may be increased to 900 mg daily for 4 months.
Primary Outcome Measure Information:
Title
Depression severity as measured by Hamilton Depression rating scale.
Description
To compare the change in depression severity in cancer patients with mild to moderate depression on sertraline and St. John's wort.
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Somnolence, nausea, and insomnia as assessed by the NCI Common Toxicity Criteria. The Epworth Sleepiness Scale will also be used to assess somnolence.
Time Frame
4 months
Title
Fatigue as measured by the Functional Assessment of Chronic Illness Therapy-Fatigue Scale.
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonius A. Miller, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Edward G. Shaw, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
Bay Area Tumor Institute
City
Oakland
State/Province
California
ZIP/Postal Code
94609-3305
Country
United States
Facility Name
Regional Radiation Oncology Center at Rome
City
Rome
State/Province
Georgia
ZIP/Postal Code
30165
Country
United States
Facility Name
CCOP - Central Illinois
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Facility Name
CCOP - Southeast Cancer Control Consortium
City
Goldsboro
State/Province
North Carolina
ZIP/Postal Code
27534-9479
Country
United States
Facility Name
High Point Regional Hospital
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27261
Country
United States
Facility Name
Comprehensive Cancer Center at Wake Forest University
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-1082
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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