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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

Brief Summary:
Major Depressive Disorder (MDD) Study in Elderly Outpatients

Condition or disease Intervention/treatment Phase
Depressive Disorder, Major Major Depressive Disorder (MDD) Drug: Paroxetine CR Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 560 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official 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
Study Start Date : June 2003
Actual Primary Completion Date : January 2005
Actual Study Completion Date : January 2005





Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00067444


  Show 46 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline

Additional Information:
Study Data/Documents: Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 29060/874
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 29060/874
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 29060/874
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 29060/874
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 29060/874
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 29060/874
For additional information about this study please refer to the GSK Clinical Study Register

Publications of Results:
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

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00067444     History of Changes
Other Study ID Numbers: 29060/874
First Posted: August 21, 2003    Key Record Dates
Last Update Posted: September 1, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
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.

Keywords provided by GlaxoSmithKline:
Elderly
Major Depressive Disorder
MDD

Additional relevant MeSH terms:
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Paroxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors