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

Verified by: Creighton University, August 2011
First Received: December 12, 2007 | Last Updated: August 15, 2011 | Phase: Phase 4 | Start Date: February 2007
Overall Status: Withdrawn | Estimated Enrollment: 0
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The purpose of this study is to test whether once-weekly prozac therapy leads to reduction in depression in patients requiring kidney dialysis...

Brief Summary

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: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
  • Study Primary Completion Date: August 2008

Detailed Clinical Trial 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.

Intervention(s) in this Clinical Trial

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

Outcome Measures for this Clinical Trial

Primary Measures

  • 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
      Safety Issue?: Yes

Criteria for Participation in this Clinical Trial

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

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

Clinical Trial Investigator Information

Lead Investigator: Creighton University Other

Overall Clinical Trial Officials and Contacts

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

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

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

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