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Depression Study In Elderly Patients

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ClinicalTrials.gov Identifier: NCT00067444
Recruitment Status : Completed
First Posted : August 21, 2003
Last Update Posted : September 1, 2016
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

August 19, 2003
August 21, 2003
September 1, 2016
June 2003
January 2005   (Final data collection date for primary outcome measure)
Change from baseline to the week 10 last observation carried forward endpoint in the 17-item HAM-D total score. [ Time Frame: 10 Weeks ]
Not Provided
Complete list of historical versions of study NCT00067444 on ClinicalTrials.gov Archive Site
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 ]
Not Provided
Not Provided
Not Provided
 
Depression Study In Elderly Patients
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
Major Depressive Disorder (MDD) Study in Elderly Outpatients
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
  • Depressive Disorder, Major
  • Major Depressive Disorder (MDD)
Drug: Paroxetine CR
Not Provided
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
560
Not Provided
January 2005
January 2005   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
60 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00067444
29060/874
No
Not Provided
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP