Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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This study has been withdrawn prior to enrollment.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:
Information provided by:
Creighton University
ClinicalTrials.gov Identifier:
NCT00573547
First received: December 12, 2007
Last updated: August 15, 2011
Last verified: August 2011

December 12, 2007
August 15, 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 ] [ Designated as safety issue: Yes ]
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 ]
Complete list of historical versions of study NCT00573547 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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
Both
19 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00573547
05-13860
No
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