Sertraline Compared With Hypericum Perforatum (St. John's Wort) in Treating Mild to Moderate Depression in Patients With Cancer - Full Text View

Sponsor:	Wake Forest University
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00066859

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	Dietary Supplement: St. John's wort Drug: sertraline hydrochloride	Phase III

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Double-Blind, Active Control
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:

MedlinePlus related topics: Cancer Depression

Drug Information available for: Sertraline hydrochloride Sertraline

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

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

Secondary Outcome Measures:

Compare the severity of somnolence, nausea, and insomnia at 4 months
Compare the impact of therapy at 4 months
Correlate the hyperforin concentrations with the change in depression severity at 4 months

Study Start Date:

August 2003

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

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

Contacts and Locations

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
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
CCOP - Southeast Cancer Control Consortium
Goldsboro, North Carolina, United States, 27534-9479

Sponsors and Collaborators

Wake Forest University

National Cancer Institute (NCI)

Investigators

Study Chair:	Antonius A. Miller, MD	Wake Forest University
Investigator:	Stephen Rapp, PhD	Wake Forest University
Investigator:	Edward G. Shaw, MD	Wake Forest University
Investigator:	W. Vaughn McCall, MD	Wake Forest University

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000320508, CCCWFU-98101, CCCWFU-BGOI-152
Study First Received:	August 6, 2003
Last Updated:	May 9, 2009
ClinicalTrials.gov Identifier:	NCT00066859 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

depression
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:

Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Depression
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Depressive Disorder
Serotonin Uptake Inhibitors
Pharmacologic Actions

Behavioral Symptoms
Serotonin Agents
Mental Disorders
Therapeutic Uses
Mood Disorders
Sertraline
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on November 25, 2009