Text Size

Depression Study In Elderly Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00067444
First received: August 19, 2003
Last updated: November 8, 2012
Last verified: November 2012
History of Changes
  Purpose

Major Depressive Disorder (MDD) Study in Elderly Outpatients


Condition Intervention Phase
Depressive Disorder, Major
Major Depressive Disorder (MDD)
 Drug: Paroxetine CR
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:

MedlinePlus related topics: Depression
U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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:
  • 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 ]

Enrollment: 525
Study Start Date: June 2003
Intervention Details:
    Drug: Paroxetine CR
    Other Name: Paroxetine CR
  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00067444

  Show 45 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00067444     History of Changes
Other Study ID Numbers: 29060/874
Study First Received: August 19, 2003
Last Updated: November 8, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
MDD
Elderly
Major Depressive Disorder

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Paroxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013