Open Label Trial of Fluoxetine for the Treatment of Depre... | NCT00573547

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

NCT00573547

Sponsor

Creighton University

Status

Withdrawn

Last Update Posted

Aug 16, 2011Estimated

Enrollment

0Actual

Phase

Phase 4

Conditions

Depression

Interventions

Fluoxetine

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2011

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Principal Investigator decided not to initiate the study.

Expanded Access Info

Start Date

Feb 2007

Primary Completion Date

Aug 2008Actual

Completion Date

Aug 2008Actual

First Submitted Date

Dec 12, 2007

First Submission Date that Met QC Criteria

Dec 12, 2007

First Posted Date

Dec 14, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 15, 2011

Last Update Posted Date

Aug 16, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Name	Type	Description	Arm Group Labels	Other Names
Fluoxetine	Drug	Fluoxetine will be dosed at 90 mg once a week		Prozac

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Syed P Sattar, MD	Creighton University Department of Psychiatry	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Creighton Department of Psychiatry		Omaha	Nebraska	68131	United States
Creighton University Department of Psychiatry

Condition Browse Module

MeSH Terms

ID	Term
D003863	Depression
D007676	Kidney Failure, Chronic

Ancestor Terms

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior
D051436	Renal Insufficiency, Chronic
D051437	Renal Insufficiency

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D005473	Fluoxetine

Ancestor Terms

ID	Term
D011437	Propylamines
D000588	Amines
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided