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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2008-08-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Depression

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Fluoxetine

Fluoxetine will be dosed at 90 mg once a week

Intervention Type DRUG

Other Intervention Names

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Prozac

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No