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

Depression Clinical Trial

Official title:

A 12-Week Open-Label Trial of Once-Weekly Fluoxetine for the Treatment of Depression in Patients With End-Stage Renal Disease

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00573547
• Other study ID #: 05-13860
• Status: Withdrawn
• Phase: Phase 4
• First received: December 12, 2007
• Last updated: August 15, 2011
• Start date: February 2007
• Est. completion date: August 2008

Study information

• Verified date: August 2011
• Source: Creighton University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to test whether once-weekly prozac therapy leads to reduction in depression in patients requiring kidney dialysis.

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 information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 65 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

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

Locations

Country	Name	City	State
United States	Creighton Department of Psychiatry	Omaha	Nebraska
United States	Creighton University Department of Psychiatry	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
Creighton University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes