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

Phase 3

Completed

• Conditions: Depression; Unspecified Adult Solid Tumor, Protocol Specific
• Interventions: Drug: Zoloft 50 mg; Dietary Supplement: St. John's Wort 600 mg

• Registration Number: NCT00066859
• Lead Sponsor: Wake Forest University Health Sciences

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.

Study Timeline

• Study First Submitted: 2003-08-06
• Study First Submitted QC: 2003-08-06
• Study First Posted: 2003-08-07
• Study Start: 2004-03-01
• Primary Completion: 2005-04-01
• Study Completion: 2005-11-01
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-07
• Last Update Posted: 2021-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1: Sertraline (Zoloft) 50 mg	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
Arm 2 - St. John's Wort 600mg	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 four months.

Primary Outcome Measures

Name	Time	Method
Depression severity as measured by Hamilton Depression rating scale.	4 months	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

Name	Time	Method
Fatigue as measured by the Functional Assessment of Chronic Illness Therapy-Fatigue Scale.	4 months
Somnolence, nausea, and insomnia as assessed by the NCI Common Toxicity Criteria. The Epworth Sleepiness Scale will also be used to assess somnolence.	4 months

Trial Locations

Locations (6)

CCOP - Central Illinois; 🇺🇸 Decatur, Illinois, United States

Comprehensive Cancer Center at Wake Forest University; 🇺🇸 Winston-Salem, North Carolina, United States

Bay Area Tumor Institute; 🇺🇸 Oakland, California, United States

Regional Radiation Oncology Center at Rome; 🇺🇸 Rome, Georgia, United States

CCOP - Southeast Cancer Control Consortium; 🇺🇸 Goldsboro, North Carolina, United States

High Point Regional Hospital; 🇺🇸 High Point, North Carolina, United States