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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00573547
Recruitment Status : Withdrawn (Principal Investigator decided not to initiate the study.)
First Posted : December 14, 2007
Last Update Posted : August 16, 2011
Information provided by:
Creighton University

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.

Condition or disease Intervention/treatment Phase
Depression Drug: Fluoxetine Phase 4

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  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : February 2007
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Fluoxetine

Intervention Details:
  • Drug: Fluoxetine
    Fluoxetine will be dosed at 90 mg once a week
    Other Name: Prozac

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00573547

United States, Nebraska
Creighton Department of Psychiatry
Omaha, Nebraska, United States, 68131
Creighton University Department of Psychiatry
Omaha, Nebraska, United States, 68131
Sponsors and Collaborators
Creighton University
Principal Investigator: Syed P Sattar, MD Creighton University Department of Psychiatry

Responsible Party: Syed Pirzada Sattar, M.D., Creighton University Identifier: NCT00573547     History of Changes
Other Study ID Numbers: 05-13860
First Posted: December 14, 2007    Key Record Dates
Last Update Posted: August 16, 2011
Last Verified: August 2011

Keywords provided by Creighton University:
chronic renal failures
end stage renal disease

Additional relevant MeSH terms:
Depressive Disorder
Kidney Diseases
Kidney Failure, Chronic
Behavioral Symptoms
Mood Disorders
Mental Disorders
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors