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Open Label Trial of Fluoxetine for the Treatment of Depression in Patients With End Stage Renal Disease

A 12-Week Open-Label Trial of Once-Weekly Fluoxetine for the Treatment of Depression in Patients With End-Stage Renal Disease

Status
Withdrawn
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00573547
Enrollment
0
Registered
2007-12-14
Start date
2007-02-28
Completion date
2008-08-31
Last updated
2011-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

Keywords

depression, chronic renal failures, end stage renal disease

Brief summary

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.

Interventions

DRUGFluoxetine

Fluoxetine will be dosed at 90 mg once a week

Sponsors

Creighton University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
19 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frame
Determine the efficacy and tolerability of once-weekly fluoxetine in patients with End Stage Renal Disorder who have been diagnosed with depressionPatients will come in for once weekly visits for 12 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026