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.

Study Type: Interventional

Study Design: Treatment, Open Label, Single Group Assignment, Efficacy Study

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.

Intervention(s) in this Clinical Trial

• Drug: Fluoxetine
  • Fluoxetine will be dosed at 90 mg once a week

Primary Measures

• Determine the efficacy and tolerability of once-weekly fluoxetine in aptients with End Stage Renal Disorder who have been diagnosed with depression
  • Time Frame: Patients will come in for once weekly visits for 12 weeks
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 19 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Creighton University

Overall Clinical Trial Officials and Contacts

Syed P Sattar, MD Principal Investigator Creighton University Department of Psychiatry  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00573547

Study ID Number: 05-13860

ClinicalTrials.gov Identifier: NCT00573547

Health Authority: United States: Institutional Review Board