Clinical trial NCT00067444: Depression Study In Elderly Patients
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Depressive Disorder, Major
Major Depressive Disorder (MDD)
Keywords: Elderly
Major Depressive Disorder
MDD
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2003-08-21
Enrollment: 560
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Change from baseline to the week 10 last observation carried forward endpoint in the 17-item HAM-D total score.
timeFrame: 10 Weeks
Secondary outcomes:
measure: 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.
timeFrame: 10 Weeks
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: GSK Investigational Site
state: Arkansas
city: Anaheim
country: United States
facility: GSK Investigational Site
state: California
city: Beverly Hills
country: United States
facility: GSK Investigational Site
state: California
city: El Centro
country: United States
facility: GSK Investigational Site
state: California
city: Los Angeles
country: United States
facility: GSK Investigational Site
state: California
city: Redlands
country: United States
facility: GSK Investigational Site
state: California
city: Santa Ana
country: United States
facility: GSK Investigational Site
state: California
city: Colorado Springs
country: United States
facility: GSK Investigational Site
state: Colorado
city: Norwich
country: United States
facility: GSK Investigational Site
state: Connecticut
city: Jacksonville
country: United States
facility: GSK Investigational Site
state: Florida
city: Leesburg
country: United States
facility: GSK Investigational Site
state: Florida
city: Miami
country: United States
facility: GSK Investigational Site
state: Florida
city: Miami
country: United States
facility: GSK Investigational Site
state: Florida
city: Orlando
country: United States
facility: GSK Investigational Site
state: Florida
city: Sebring
country: United States
facility: GSK Investigational Site
state: Florida
city: St. Petersburg
country: United States
facility: GSK Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: GSK Investigational Site
state: Florida
city: Marietta
country: United States
facility: GSK Investigational Site
state: Georgia
city: Boise
country: United States
facility: GSK Investigational Site
state: Idaho
city: Lafayette
country: United States
facility: GSK Investigational Site
state: Indiana
city: Overland Park
country: United States
facility: GSK Investigational Site
state: Kansas
city: Prairie Village
country: United States
facility: GSK Investigational Site
state: Kansas
city: Gaithersburg
country: United States
facility: GSK Investigational Site
state: Maryland
city: Rockville
country: United States
facility: GSK Investigational Site
state: Maryland
city: Braintree
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Nashua
country: United States
facility: GSK Investigational Site
state: New Hampshire
city: Clementon
country: United States
facility: GSK Investigational Site
state: New Jersey
city: Princeton
country: United States
facility: GSK Investigational Site
state: New Jersey
city: Mount Kisco
country: United States
facility: GSK Investigational Site
state: New York
city: New York
country: United States
facility: GSK Investigational Site
state: New York
city: New York
country: United States
facility: GSK Investigational Site
state: New York
city: Charlotte
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Greensboro
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Oklahoma City
country: United States
facility: GSK Investigational Site
state: Oklahoma
city: Eugene
country: United States
facility: GSK Investigational Site
state: Oregon
city: Conshohocken
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: East Providence
country: United States
facility: GSK Investigational Site
state: Rhode Island
city: Charleston
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Memphis
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Austin
country: United States
facility: GSK Investigational Site
state: Texas
city: Houston
country: United States
facility: GSK Investigational Site
state: Texas
city: San Antonio
country: United States
facility: GSK Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: GSK Investigational Site
state: Utah
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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