Open Label Trial of Fluoxetine for the Treatment of Depression in Patients With End Stage Renal Disease
Phase 4
Withdrawn
- Conditions
- Depression
- Registration Number
- NCT00573547
- Lead Sponsor
- Creighton University
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Determine the efficacy and tolerability of once-weekly fluoxetine in patients with End Stage Renal Disorder who have been diagnosed with depression Patients will come in for once weekly visits for 12 weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Creighton University Department of Psychiatry
🇺🇸Omaha, Nebraska, United States
Creighton Department of Psychiatry
🇺🇸Omaha, Nebraska, United States