Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
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
Trial description: Major Depressive Disorder (MDD) Study in Elderly Outpatients
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
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:
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
Interventions:
Enrollment:
560
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
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
Medical condition
Depressive Disorder, Major
Product
paroxetine
Collaborators
Not applicable
Study date(s)
June 2003 to January 2005
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
60 years - 0 Not applicable
Accepts healthy volunteers
No
- Diagnosis of Major Depressive Disorder (MDD).
- Current major depressive episode at screen at least 2 months duration.
- Patients with a primary diagnosis other than MDD.
- Patients with a history of schizophrenia, schizoaffective disorder, bipolar disorder or dementia.
Inclusion and exclusion 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.
Trial location(s)
Location
GSK Investigational Site
New York, New York, United States, 10024
Status
Study Complete
Location
GSK Investigational Site
Prairie Village, Kansas, United States, 66206
Status
Study Complete
Location
GSK Investigational Site
Marietta, Georgia, United States, 30060
Status
Study Complete
Location
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73118
Status
Study Complete
Location
GSK Investigational Site
Lafayette, Indiana, United States, 47905
Status
Study Complete
Location
GSK Investigational Site
West Palm Beach, Florida, United States, 33407
Status
Study Complete
Location
GSK Investigational Site
St. Petersburg, Florida, United States, 33710
Status
Study Complete
Location
GSK Investigational Site
Mount Kisco, New York, United States, 10549
Status
Study Complete
Location
GSK Investigational Site
Overland Park, Kansas, United States, 66211
Status
Study Complete
Location
GSK Investigational Site
Charlotte, North Carolina, United States, 28209
Status
Study Complete
Location
GSK Investigational Site
Los Angeles, California, United States, 90048
Status
Study Complete
Location
GSK Investigational Site
Jacksonville, Florida, United States, 32216
Status
Study Complete
Location
GSK Investigational Site
El Centro, California, United States, 92243
Status
Study Complete
Location
GSK Investigational Site
Rockville, Maryland, United States, 20852
Status
Study Complete
Location
GSK Investigational Site
Gaithersburg, Maryland, United States, 20877
Status
Study Complete
Location
GSK Investigational Site
Anaheim, California, United States, 92805
Status
Study Complete
Location
GSK Investigational Site
Norwich, Connecticut, United States, 06360
Status
Study Complete
Location
GSK Investigational Site
Charleston, South Carolina, United States, 29407
Status
Study Complete
Location
GSK Investigational Site
Conshohocken, Pennsylvania, United States, 19428
Status
Study Complete
Location
GSK Investigational Site
Princeton, New Jersey, United States, 08540
Status
Study Complete
Location
GSK Investigational Site
East Providence, Rhode Island, United States, 02914
Status
Study Complete
Location
GSK Investigational Site
Leesburg, Florida, United States, 34748
Status
Study Complete
Location
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19104
Status
Study Complete
Location
GSK Investigational Site
Memphis, Tennessee, United States, 38119
Status
Study Complete
Location
GSK Investigational Site
Sebring, Florida, United States, 33870
Status
Study Complete
Location
GSK Investigational Site
Redlands, California, United States, 92374
Status
Study Complete
Location
GSK Investigational Site
Santa Ana, California, United States, 92705
Status
Study Complete
Location
GSK Investigational Site
Nashua, New Hampshire, United States, 03060
Status
Study Complete
Location
GSK Investigational Site
New York, New York, United States, 10021
Status
Study Complete
Location
GSK Investigational Site
Greensboro, North Carolina, United States, 27401
Status
Study Complete
Location
GSK Investigational Site
Little Rock, Arkansas, United States, 72223
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78229-3815
Status
Study Complete
Location
GSK Investigational Site
Colorado Springs, Colorado, United States, 80904
Status
Study Complete
Location
GSK Investigational Site
Beverly Hills, California, United States, 90210
Status
Study Complete
Location
GSK Investigational Site
Raleigh, North Carolina, United States, 27609
Status
Study Complete
Location
GSK Investigational Site
Braintree, Massachusetts, United States, 02184
Status
Study Complete
Location
GSK Investigational Site
Clementon, New Jersey, United States, 08021
Status
Study Complete
Location
GSK Investigational Site
Salt Lake City, Utah, United States, 84107
Status
Study Complete
Location
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19115
Status
Study Complete
Location
GSK Investigational Site
Orlando, Florida, United States, 32806
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2005-21-01
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
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