Open Label Trial of Fluoxetine for the Treatment of Depression in Patients With End Stage Renal Disease
Information source: Creighton University
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Depression
Intervention: Fluoxetine (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: Creighton University Official(s) and/or principal investigator(s):
Syed P Sattar, MD, Principal Investigator, Affiliation: Creighton University Department of Psychiatry
Summary
The purpose of this study is to test whether once-weekly prozac therapy leads to reduction in
depression in patients requiring kidney dialysis.
Clinical Details
Official title: A 12-Week Open-Label Trial of Once-Weekly Fluoxetine for the Treatment of Depression in Patients With End-Stage Renal Disease
Study design: Treatment, Open Label, Single Group Assignment, Efficacy Study
Primary outcome: Determine the efficacy and tolerability of once-weekly fluoxetine in aptients with End Stage Renal Disorder who have been diagnosed with depression
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.
Eligibility
Minimum age: 19 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Diagnosis of chronic renal failure and end stage renal disease
- Ongoing need for regular dialysis treatment
- Diagnosis of dperession 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
Locations and Contacts
Creighton University Department of Psychiatry, Omaha, Nebraska 68131, United States
Creighton Department of Psychiatry, Omaha, Nebraska 68131, United States
Additional Information
Starting date: February 2007
Ending date: August 2008
Last updated: December 12, 2007
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