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

August 15, 2011 updated by: Creighton University

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 Overview

Status

Withdrawn

Conditions

Depression

Intervention / Treatment

Drug: Fluoxetine

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 Type

Interventional

Phase

Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Nebraska
  - Omaha, Nebraska, United States, 68131
    - Creighton University Department of Psychiatry
  - Omaha, Nebraska, United States, 68131
    - Creighton Department of Psychiatry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	Patients will come in for once weekly visits for 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Creighton University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

August 1, 2008

Study Registration Dates

First Submitted

December 12, 2007

First Submitted That Met QC Criteria