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

C

Creighton University

Status and phase

Withdrawn
Phase 4

Conditions

Depression

Treatments

Drug: Fluoxetine

Study type

Interventional

Funder types

Other

Identifiers

NCT00573547
05-13860

Details and patient eligibility

About

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

Full 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.

Sex

All

Ages

19 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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