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

This study has been withdrawn prior to enrollment.

( Principal Investigator decided not to initiate the study. )

First Received on December 12, 2007. Last Updated on August 15, 2011 History of Changes

Sponsor:	Creighton University
Information provided by:	Creighton University
ClinicalTrials.gov Identifier:	NCT00573547

Purpose

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

Condition	Intervention	Phase
Depression	Drug: Fluoxetine	Phase IV

Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A 12-Week Open-Label Trial of Once-Weekly Fluoxetine for the Treatment of Depression in Patients With End-Stage Renal Disease

Resource links provided by NLM:

MedlinePlus related topics: Depression Kidney Failure

Drug Information available for: Fluoxetine Fluoxetine hydrochloride

U.S. FDA Resources

Further study details as provided by Creighton University:

Primary Outcome 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 ] [ Designated as safety issue: Yes ]

Enrollment:	0
Study Start Date:	February 2007
Study Completion Date:	August 2008
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Intervention Details:

Fluoxetine will be dosed at 90 mg once a week

Other Name: Prozac

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.

Eligibility

Ages Eligible for Study:	19 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00573547

Locations

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

Sponsors and Collaborators

Creighton University

Investigators

Principal Investigator:

Syed P Sattar, MD

Creighton University Department of Psychiatry

More Information

No publications provided

Responsible Party:	Syed Pirzada Sattar, M.D., Creighton University
ClinicalTrials.gov Identifier:	NCT00573547 History of Changes
Other Study ID Numbers:	05-13860
Study First Received:	December 12, 2007
Last Updated:	August 15, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Creighton University:

depression
chronic renal failures
end stage renal disease

Additional relevant MeSH terms:

Depression
Depressive Disorder
Kidney Diseases
Kidney Failure, Chronic
Behavioral Symptoms
Mood Disorders
Mental Disorders
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Fluoxetine
Serotonin Uptake Inhibitors

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 12, 2012