DepressionPhase 3NCT00066859
Sertraline Compared With Hypericum Perforatum (St.John's Wort) in Treating Depression
A Phase 3 study testing Zoloft 50 mg and St. John's Wort 600 mg in people with Depression and Unspecified Adult Solid Tumor, Protocol Specific, run by Wake Forest University Health Sciences at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- Zoloft 50 mg and St. John's Wort 600 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 6 sitesUnited States
- Study dates
- 1 Mar 2004to 1 Nov 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
CCOP - Central Illinois
Decatur, Illinois, 62526
CCOP - Southeast Cancer Control Consortium
Goldsboro, North Carolina, 27534-9479
High Point Regional Hospital
High Point, North Carolina, 27261
Bay Area Tumor Institute
Oakland, California, 94609-3305
Regional Radiation Oncology Center at Rome
Rome, Georgia, 30165
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, 27157-1082
About this study
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
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.
Read the 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.
- Being tested
- Zoloft 50 mg, St. John's Wort 600 mg
- Keywords
- depression, unspecified adult solid tumor, protocol specific
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zoloft 50 mgDrug
Also called Sertraline, Zoloft
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 mgDietary supplement
Also called Hypericum perforatum
St. John's wort 600 mg daily for 1 week, if tolerated. Dose may be increased to 900 mg daily for 4 months.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Dietary Supplement: St. John's Wort 600 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 4 months
Fatigue as measured by the Functional Assessment of Chronic Illness Therapy-Fatigue Scale.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2003 (estimated)
- Study start1 Mar 2004
- Primary completion1 Apr 2005
- Study completion1 Nov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Antonius A. Miller, MD, Principal investigator, Wake Forest University Health SciencesEdward G. Shaw, MD, Study chair, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00066859
- Sponsor's protocol ID
- REBACCCWFU-98101
- Other IDs
- U10CA081851
- Status last verified
- Sep 2021
- First submitted
- 6 Aug 2003
- Last updated
- 9 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00066859
- Acronym / sponsor ID
- REBACCCWFU-98101
- Keywords
- depression, unspecified adult solid tumor, protocol specific
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Mar 2004
- Primary completion
- 1 Apr 2005 (actual)
- Study completion
- 1 Nov 2005 (actual)
- First posted
- 7 Aug 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Sertraline (Zoloft) 50 mg | Active comparator | Drug: Zoloft 50 mgZoloft 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 | Active comparator | Dietary Supplement: St. John's Wort 600 mgSt. John's wort 600 mg daily for 1 week. If tolerated dose may be increased to 900 mg daily for four months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zoloft 50 mgAlso: Sertraline, ZoloftZoloft 50 mg by mouth daily for 1 week if tolerated dose may be increased to 100 mg daily for 4 months | Drug | Arm 1: Sertraline (Zoloft) 50 mg |
| St. John's Wort 600 mgAlso: Hypericum perforatumSt. John's wort 600 mg daily for 1 week, if tolerated. Dose may be increased to 900 mg daily for 4 months. | Dietary supplement | Arm 2 - St. John's Wort 600mg |
Primary outcome
Depression severity as measured by Hamilton Depression rating scale.
Time frame: 4 months
To compare the change in depression severity in cancer patients with mild to moderate depression on sertraline and St. John's wort.
2 secondary outcomes
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
Fatigue as measured by the Functional Assessment of Chronic Illness Therapy-Fatigue Scale.
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonius A. Miller, MD principal investigator
Wake Forest University Health Sciences
Edward G. Shaw, MD study chair
Wake Forest University Health Sciences
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Zoloft 50 mg and St. John's Wort 600 mg in people with Depression and Unspecified Adult Solid Tumor, Protocol Specific, run by Wake Forest University Health Sciences at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression severity as measured by Hamilton Depression rating scale. (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2021.