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

NCT00066859 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2021-09-09

No results posted yet for this study

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.

Conditions

  • Depression
  • Unspecified Adult Solid Tumor, Protocol Specific

Interventions

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

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.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Antonius A. Miller, MD · Wake Forest University Health Sciences

  • Edward G. Shaw, MD · Wake Forest University Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-03-01
Primary Completion
2005-04-01
Completion
2005-11-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00066859 on ClinicalTrials.gov