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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This study has been withdrawn prior to enrollment.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.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00573547
First Posted: December 14, 2007
Last Update Posted: August 16, 2011
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.
Information provided by:
Creighton University
December 12, 2007
December 14, 2007
August 16, 2011
February 2007
August 2008   (Final data collection date for primary outcome measure)
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 ]
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 ]
Complete list of historical versions of study NCT00573547 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Open Label Trial of Fluoxetine for the Treatment of Depression in Patients With End Stage Renal Disease
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.
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.
Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Depression
Drug: Fluoxetine
Fluoxetine will be dosed at 90 mg once a week
Other Name: Prozac
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
August 2008
August 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
19 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00573547
05-13860
No
Not Provided
Not Provided
Syed Pirzada Sattar, M.D., Creighton University
Creighton University
Not Provided
Principal Investigator: Syed P Sattar, MD Creighton University Department of Psychiatry
Creighton University
August 2011

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