A 12-Week Open-Label Trial of Once-Weekly Fluoxetine for the Treatment of Depression in Patients With End-Stage Renal Disease
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Depression
- Sponsor
- Creighton University
- Locations
- 2
- Primary Endpoint
- Determine the efficacy and tolerability of once-weekly fluoxetine in patients with End Stage Renal Disorder who have been diagnosed with depression
- Status
- Withdrawn
- Last Updated
- 14 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
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