Depression Study In Elderly Patients

NCT ID: NCT00067444

Last Updated: 2016-09-01

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

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

560 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-06-30

Study Completion Date

2005-01-31

Brief Summary

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Major Depressive Disorder (MDD) Study in Elderly Outpatients

Detailed Description

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Conditions

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Depressive Disorder, Major Major Depressive Disorder (MDD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Paroxetine CR

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of Major Depressive Disorder (MDD).
* Current major depressive episode at screen at least 2 months duration.
* Must be at least 60 years of age.

Exclusion Criteria

* Patients with a primary diagnosis other than MDD.
* Patients with a history of schizophrenia, schizoaffective disorder, bipolar disorder or dementia.
* Patients with a history of brief depressive episodes lasting less than 8 weeks.
* Patients receiving formal psychotherapy within 12 weeks of study.
* Patients who are suicidal.
* Patients who have received electroconvulsive therapy or transcranial magnetic stimulation within 6 months prior to screening.
* Patients with a history or seizure disorders.
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Little Rock, Arkansas, United States

Site Status

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Anaheim, California, United States

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Beverly Hills, California, United States

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El Centro, California, United States

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Los Angeles, California, United States

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Redlands, California, United States

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Santa Ana, California, United States

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Colorado Springs, Colorado, United States

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Norwich, Connecticut, United States

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Jacksonville, Florida, United States

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Leesburg, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Orlando, Florida, United States

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Sebring, Florida, United States

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St. Petersburg, Florida, United States

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West Palm Beach, Florida, United States

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Marietta, Georgia, United States

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Boise, Idaho, United States

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Lafayette, Indiana, United States

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Overland Park, Kansas, United States

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Prairie Village, Kansas, United States

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Gaithersburg, Maryland, United States

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Rockville, Maryland, United States

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Braintree, Massachusetts, United States

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Nashua, New Hampshire, United States

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Clementon, New Jersey, United States

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Princeton, New Jersey, United States

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Mount Kisco, New York, United States

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New York, New York, United States

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New York, New York, United States

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Charlotte, North Carolina, United States

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Greensboro, North Carolina, United States

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Raleigh, North Carolina, United States

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Oklahoma City, Oklahoma, United States

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Eugene, Oregon, United States

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Conshohocken, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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East Providence, Rhode Island, United States

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Charleston, South Carolina, United States

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Memphis, Tennessee, United States

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Austin, Texas, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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Salt Lake City, Utah, United States

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Countries

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United States

References

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Pitts CD, Schaefer D, Lipschitz A, Iyengar M: Efficacy and Tolerability of Fixed, Low Dose Paroxetine CR in the Treatment of Depression in the Elderly, Poster No. NR701, presented at the American Psychiatric Association Annual Meeting, May 2005. Available at: www.psych.org

Reference Type RESULT

Study Documents

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Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

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https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

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29060/874

Identifier Type: -

Identifier Source: org_study_id

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