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

Tracking Information

First Received Date ^ICMJE

December 12, 2007

Last Updated Date

December 12, 2007

Start Date ^ICMJE

February 2007

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Open Label, Single Group Assignment, Efficacy Study

Condition ^ICMJE

Depression

Intervention ^ICMJE

Drug: Fluoxetine

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

August 2008

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Both

Ages

19 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00573547

Responsible Party

Syed Pirzada Sattar, M.D., Creighton University

Study ID Numbers ^ICMJE

05-13860

Study Sponsor ^ICMJE

Creighton University

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Syed P Sattar, MD

Creighton University Department of Psychiatry

Information Provided By

Creighton University

Verification Date

December 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP