DepressionPhase 4NCT00573547
Open Label Trial of Fluoxetine for the Treatment of Depression in Patients With End Stage Renal Disease
A Phase 4 study testing Fluoxetine in people with Depression, run by Creighton University at 2 sites in United States.
Trial summary
The purpose of this study is to test whether once-weekly prozac therapy leads to reduction in depression in patients requiring kidney dialysis. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Depression
- What is being tested?
- Fluoxetine
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2007to Aug 2008
- Phase
- Phase 4
- 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 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of chronic renal failure and end stage renal disease
- Ongoing need for regular dialysis treatment
- Diagnosis of depression based on DSMIV
- Age tween 19-65 years
Who cannot join
- Inability to provide informed consent
- Medically or psychiatrically unstable, as defined by requiring inpatient treatment
- Pregnancy, nursing or refusal to use a reliable method of birth control in women
- Patients with known allergy to fluoxetine, or previous treatment failure of fluoxetine
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Creighton Department of Psychiatry
Omaha, Nebraska, 68131
Creighton University Department of Psychiatry
Omaha, Nebraska, 68131
About this study
Official title: A 12-Week Open-Label Trial of Once-Weekly Fluoxetine for the Treatment of Depression in Patients With End-Stage Renal Disease
The purpose of this study is to test whether once-weekly prozac therapy leads to reduction in depression in patients requiring kidney dialysis.
Read the detailed description
Once-weekly Prozac is a psychiatric medicine, approved by the FDA for the use in treatment of psychiatric disorders. This study will test whether once-weekly Prozac leads to reduced symptoms of depression. Patients requiring dialysis often report symptoms of depression either due to the presence of major depression, a relatively common psychiatric disorder, or due to depression secondary to kidney failure.
- Conditions
- Depression
- Being tested
- Fluoxetine
- Keywords
- depression, chronic renal failures, end stage renal disease
- Medical subject headings
- Depression, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluoxetineDrug
Also called Prozac
Fluoxetine will be dosed at 90 mg once a week
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the efficacy and tolerability of once-weekly fluoxetine in patients with End Stage Renal Disorder who have been diagnosed with depression
Measured: Patients will come in for once weekly visits for 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2007 (estimated)
- Study startFeb 2007
- Primary completionAug 2008
- Study completionAug 2008
Why it stopped: Principal Investigator decided not to initiate the study.
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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Creighton University
- Sponsor type
- University, hospital or other
- Investigators
- Syed P Sattar, MD, Principal investigator, Creighton University Department of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00573547
- Sponsor's protocol ID
- 05-13860
- Status last verified
- Aug 2011
- First submitted
- 12 Dec 2007
- Last updated
- 16 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-Week Open-Label Trial of Once-Weekly Fluoxetine for the Treatment of Depression in Patients With End-Stage Renal Disease
- ClinicalTrials.gov ID
- NCT00573547
- Acronym / sponsor ID
- 05-13860
- Conditions
- Depression
- Keywords
- depression, chronic renal failures, end stage renal disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Principal Investigator decided not to initiate the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Creighton UniversityUniversity, hospital or other
- Study start
- Feb 2007
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 14 Dec 2007 (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.
The purpose of this study is to test whether once-weekly prozac therapy leads to reduction in depression in patients requiring kidney dialysis.
Detailed description
Once-weekly Prozac is a psychiatric medicine, approved by the FDA for the use in treatment of psychiatric disorders. This study will test whether once-weekly Prozac leads to reduced symptoms of depression. Patients requiring dialysis often report symptoms of depression either due to the presence of major depression, a relatively common psychiatric disorder, or due to depression secondary to kidney failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of chronic renal failure and end stage renal disease
- Ongoing need for regular dialysis treatment
- Diagnosis of depression based on DSMIV
- Age tween 19-65 years
Key exclusion criteria (4 listed)
- Inability to provide informed consent
- Medically or psychiatrically unstable, as defined by requiring inpatient treatment
- Pregnancy, nursing or refusal to use a reliable method of birth control in women
- Patients with known allergy to fluoxetine, or previous treatment failure of fluoxetine
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 |
|---|---|---|
| FluoxetineAlso: ProzacFluoxetine will be dosed at 90 mg once a week | Drug | – |
Primary outcome
Determine the efficacy and tolerability of once-weekly fluoxetine in patients with End Stage Renal Disorder who have been diagnosed with depression
Time frame: Patients will come in for once weekly visits for 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2011.
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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.
Syed P Sattar, MD principal investigator
Creighton University Department of Psychiatry
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fluoxetine in people with Depression, run by Creighton University at 2 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 4 inclusion and 4 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: withdrawn, as of the sponsor's last update on 16 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was withdrawn before enrolling participants, so there are no results.
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?
Determine the efficacy and tolerability of once-weekly fluoxetine in patients with End Stage Renal Disorder who have been diagnosed with depression (time frame: Patients will come in for once weekly visits for 12 weeks). 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 16 Aug 2011.