NCT00573547

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2007

Shorter than P25 for phase_4 depression

Geographic Reach
1 country

2 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 12, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 14, 2007

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

August 16, 2011

Status Verified

August 1, 2011

Enrollment Period

1.5 years

First QC Date

December 12, 2007

Last Update Submit

August 15, 2011

Conditions

Depression

Keywords

depressionchronic renal failuresend stage renal disease

Outcome Measures

Primary Outcomes (1)

  • Determine the efficacy and tolerability of once-weekly fluoxetine in patients with End Stage Renal Disorder who have been diagnosed with depression

    Patients will come in for once weekly visits for 12 weeks

Interventions

FluoxetineDRUG

Fluoxetine will be dosed at 90 mg once a week

Also known as: Prozac

Eligibility Criteria

Age19 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Creighton Department of Psychiatry

Omaha, Nebraska, 68131, United States

Location

Creighton University Department of Psychiatry

Omaha, Nebraska, 68131, United States

Location

MeSH Terms

Conditions

DepressionKidney Failure, Chronic

Interventions

Fluoxetine

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorRenal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic Chemicals

Study Officials

  • Syed P Sattar, MD

    Creighton University Department of Psychiatry

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 12, 2007

First Posted

December 14, 2007

Study Start

February 1, 2007

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

August 16, 2011

Record last verified: 2011-08

Locations

US(2)