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CompletedNCT00067444Updated Sep 1, 2016

Depression Study In Elderly Patients

A Phase 3 interventional study of Paroxetine CR in Depressive Disorder, Major and Major Depressive Disorder (MDD), sponsored by GlaxoSmithKline. Completed at 46 sites in United States. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2016-09-01.

Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
560
Allocation
Randomized
Ages
60 Years and older
Sex
All
01

Study summary

Major Depressive Disorder (MDD) Study in Elderly Outpatients

02

Conditions studied

  • Depressive Disorder, Major
  • Major Depressive Disorder (MDD)

Keywords

  • Elderly
  • Major Depressive Disorder
  • MDD
03

In context

Depressive Disorder

4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.

This study's enrollment of 560 is above the median of 80 across 3,999 interventional studies indexed under Depressive Disorder.

Browse Depressive Disorder studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
560 participants (actual)

Interventions

  • DrugParoxetine CR
06

What researchers measure

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

07

Study locations

46 sites
  • GSK Investigational Site
    Little Rock, Arkansas 72223, United States
  • GSK Investigational Site
    Anaheim, California 92805, United States
  • GSK Investigational Site
    Beverly Hills, California 90210, United States
  • GSK Investigational Site
    El Centro, California 92243, United States
  • GSK Investigational Site
    Los Angeles, California 90048, United States
  • GSK Investigational Site
    Redlands, California 92374, United States
  • GSK Investigational Site
    Santa Ana, California 92705, United States
  • GSK Investigational Site
    Colorado Springs, Colorado 80904, United States
  • GSK Investigational Site
    Norwich, Connecticut 06360, United States
  • GSK Investigational Site
    Jacksonville, Florida 32216, United States
  • GSK Investigational Site
    Leesburg, Florida 34748, United States
  • GSK Investigational Site
    Miami, Florida 33125, United States
  • GSK Investigational Site
    Miami, Florida 33156, United States
  • GSK Investigational Site
    Orlando, Florida 32806, United States
  • GSK Investigational Site
    Sebring, Florida 33870, United States
  • GSK Investigational Site
    St. Petersburg, Florida 33710, United States
  • GSK Investigational Site
    West Palm Beach, Florida 33407, United States
  • GSK Investigational Site
    Marietta, Georgia 30060, United States
  • GSK Investigational Site
    Boise, Idaho 83704, United States
  • GSK Investigational Site
    Lafayette, Indiana 47905, United States
  • GSK Investigational Site
    Overland Park, Kansas 66211, United States
  • GSK Investigational Site
    Prairie Village, Kansas 66206, United States
  • GSK Investigational Site
    Gaithersburg, Maryland 20877, United States
  • GSK Investigational Site
    Rockville, Maryland 20852, United States
  • GSK Investigational Site
    Braintree, Massachusetts 02184, United States
  • GSK Investigational Site
    Nashua, New Hampshire 03060, United States
  • GSK Investigational Site
    Clementon, New Jersey 08021, United States
  • GSK Investigational Site
    Princeton, New Jersey 08540, United States
  • GSK Investigational Site
    Mount Kisco, New York 10549, United States
  • GSK Investigational Site
    New York, New York 10021, United States
  • GSK Investigational Site
    New York, New York 10024, United States
  • GSK Investigational Site
    Charlotte, North Carolina 28209, United States
  • GSK Investigational Site
    Greensboro, North Carolina 27401, United States
  • GSK Investigational Site
    Raleigh, North Carolina 27609, United States
  • GSK Investigational Site
    Oklahoma City, Oklahoma 73118, United States
  • GSK Investigational Site
    Eugene, Oregon 97401, United States
  • GSK Investigational Site
    Conshohocken, Pennsylvania 19428, United States
  • GSK Investigational Site
    Philadelphia, Pennsylvania 19104, United States
  • GSK Investigational Site
    Philadelphia, Pennsylvania 19115, United States
  • GSK Investigational Site
    East Providence, Rhode Island 02914, United States
  • GSK Investigational Site
    Charleston, South Carolina 29407, United States
  • GSK Investigational Site
    Memphis, Tennessee 38119, United States
  • GSK Investigational Site
    Austin, Texas 78756, United States
  • GSK Investigational Site
    Houston, Texas 77007, United States
  • GSK Investigational Site
    San Antonio, Texas 78229-3815, United States
  • GSK Investigational Site
    Salt Lake City, Utah 84107, United States
08

References and documents

Publications

  • 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

Individual participant data

Plan to share: Yes — Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 1, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00067444
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Aug 21, 2003
Start date
Jun 2003
Primary completion
Jan 2005
Completion
Jan 2005
Last update
Sep 1, 2016

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.

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