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Completed

NCT Number: NCT00067444

Depression Study In Elderly Patients

Major Depressive Disorder (MDD) Study in Elderly Outpatients

Completed

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Key information

Conditions

Depressive Disorder, Major Depressive Disorder Major Depressive Disorder (MDD) Mental Disorders Mood Disorders

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site, Little Rock, Arkansas, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Paroxetine CR

Drug

Primary outcomes

  1. Change from baseline to the week 10 last observation carried forward endpoint in the 17-item HAM-D total score.

    Time frame: 10 Weeks

Secondary outcomes

  1. Mean change from baseline in HAM-D item 1; Mean change from baseline in the CGI severity of illness score at study endpoint; Percentage of patients with HAM-D total score less than or equal to 7.

    Time frame: 10 Weeks

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Fixed Dose Study Evaluating the Efficacy and Safety of Paroxetine CR in Elderly Outpatients Diagnosed With Major Depressive Disorder

Important dates

Study start
2003
Primary completion
2005
Study completion
2005
First posted
Aug 21, 2003
Registry last updated
Sep 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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