Depression Study In Elderly Patients

Sponsor

GlaxoSmithKline (Industry)

Overall Status

Completed

CT.gov ID

NCT00067444

Collaborator

(none)

560

Enrollment

Locations

19.1

Duration (Months)

12.2

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

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 :

Jun 1, 2003

Actual Primary Completion Date :

Jan 1, 2005

Actual Study Completion Date :

Jan 1, 2005

Outcome Measures

Primary Outcome Measures

Change from baseline to the week 10 last observation carried forward endpoint in the 17-item HAM-D total score. [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. [10 Weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Little Rock	Arkansas	United States	72223
2	GSK Investigational Site	Anaheim	California	United States	92805
3	GSK Investigational Site	Beverly Hills	California	United States	90210
4	GSK Investigational Site	El Centro	California	United States	92243
5	GSK Investigational Site	Los Angeles	California	United States	90048
6	GSK Investigational Site	Redlands	California	United States	92374
7	GSK Investigational Site	Santa Ana	California	United States	92705
8	GSK Investigational Site	Colorado Springs	Colorado	United States	80904
9	GSK Investigational Site	Norwich	Connecticut	United States	06360
10	GSK Investigational Site	Jacksonville	Florida	United States	32216
11	GSK Investigational Site	Leesburg	Florida	United States	34748
12	GSK Investigational Site	Miami	Florida	United States	33125
13	GSK Investigational Site	Miami	Florida	United States	33156
14	GSK Investigational Site	Orlando	Florida	United States	32806
15	GSK Investigational Site	Sebring	Florida	United States	33870
16	GSK Investigational Site	St. Petersburg	Florida	United States	33710
17	GSK Investigational Site	West Palm Beach	Florida	United States	33407
18	GSK Investigational Site	Marietta	Georgia	United States	30060
19	GSK Investigational Site	Boise	Idaho	United States	83704
20	GSK Investigational Site	Lafayette	Indiana	United States	47905
21	GSK Investigational Site	Overland Park	Kansas	United States	66211
22	GSK Investigational Site	Prairie Village	Kansas	United States	66206
23	GSK Investigational Site	Gaithersburg	Maryland	United States	20877
24	GSK Investigational Site	Rockville	Maryland	United States	20852
25	GSK Investigational Site	Braintree	Massachusetts	United States	02184
26	GSK Investigational Site	Nashua	New Hampshire	United States	03060
27	GSK Investigational Site	Clementon	New Jersey	United States	08021
28	GSK Investigational Site	Princeton	New Jersey	United States	08540
29	GSK Investigational Site	Mount Kisco	New York	United States	10549
30	GSK Investigational Site	New York	New York	United States	10021
31	GSK Investigational Site	New York	New York	United States	10024
32	GSK Investigational Site	Charlotte	North Carolina	United States	28209
33	GSK Investigational Site	Greensboro	North Carolina	United States	27401
34	GSK Investigational Site	Raleigh	North Carolina	United States	27609
35	GSK Investigational Site	Oklahoma City	Oklahoma	United States	73118
36	GSK Investigational Site	Eugene	Oregon	United States	97401
37	GSK Investigational Site	Conshohocken	Pennsylvania	United States	19428
38	GSK Investigational Site	Philadelphia	Pennsylvania	United States	19104
39	GSK Investigational Site	Philadelphia	Pennsylvania	United States	19115
40	GSK Investigational Site	East Providence	Rhode Island	United States	02914
41	GSK Investigational Site	Charleston	South Carolina	United States	29407
42	GSK Investigational Site	Memphis	Tennessee	United States	38119
43	GSK Investigational Site	Austin	Texas	United States	78756
44	GSK Investigational Site	Houston	Texas	United States	77007
45	GSK Investigational Site	San Antonio	Texas	United States	78229-3815
46	GSK Investigational Site	Salt Lake City	Utah	United States	84107