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

NCT00066859 | Completed Phase 3 DMC

• 2 other identifiers: REBACCCWFU-98101U10CA081851
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 6

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.

Conditions

Depression; Unspecified Adult Solid Tumor, Protocol Specific

Keywords

depression; unspecified adult solid tumor, protocol specific

Outcome Measures

Primary Outcomes (1)

• 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.

  4 months

Secondary Outcomes (2)

• 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

• Fatigue as measured by the Functional Assessment of Chronic Illness Therapy-Fatigue Scale.

  4 months

Study Arms (2)

Arm 1: Sertraline (Zoloft) 50 mg

ACTIVE COMPARATOR

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

Arm 2 - St. John's Wort 600mg

ACTIVE COMPARATOR

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

Interventions

Zoloft 50 mg DRUG

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

Also known as: Sertraline, Zoloft

Arm 1: Sertraline (Zoloft) 50 mg

St. John's Wort 600 mg DIETARY_SUPPLEMENT

St. John's wort 600 mg daily for 1 week, if tolerated. Dose may be increased to 900 mg daily for 4 months.

Also known as: Hypericum perforatum

Arm 2 - St. John's Wort 600mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

Study Sites (6)

Bay Area Tumor Institute

Oakland, California, 94609-3305, United States

Location

Regional Radiation Oncology Center at Rome

Rome, Georgia, 30165, United States

Location

CCOP - Central Illinois

Decatur, Illinois, 62526, United States

Location

CCOP - Southeast Cancer Control Consortium

Goldsboro, North Carolina, 27534-9479, United States

Location

High Point Regional Hospital

High Point, North Carolina, 27261, United States

Location

Comprehensive Cancer Center at Wake Forest University

Winston-Salem, North Carolina, 27157-1082, United States

Location

MeSH Terms

Conditions

Depression

Interventions

Sertraline; Hypericum extract LI 160

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

1-Naphthylamine; Amines; Organic Chemicals; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Officials

• Antonius A. Miller, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

• Edward G. Shaw, MD

  Wake Forest University Health Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2003
• First Posted: August 7, 2003
• Study Start: March 1, 2004
• Primary Completion: April 1, 2005
• Study Completion: November 1, 2005
• Last Updated: September 9, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)