Depressive Disorder, MajorPhase 3NCT00067444
Depression Study In Elderly Patients
A Phase 3 study testing Paroxetine CR in people with Depressive Disorder, Major and Major Depressive Disorder (MDD), run by GlaxoSmithKline at 46 sites in United States.
Trial summary
Major Depressive Disorder (MDD) Study in Elderly Outpatients Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Depressive Disorder, Major, Major Depressive Disorder (MDD)
- What is being tested?
- Paroxetine CR
- How many people
- 560 participants
- Where
- 46 sitesUnited States
- Study dates
- Jun 2003to Jan 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
46 sites in 1 country.
46 sites in 1 country
United States46 sites
GSK Investigational Site
Anaheim, California, 92805
GSK Investigational Site
Austin, Texas, 78756
GSK Investigational Site
Beverly Hills, California, 90210
GSK Investigational Site
Boise, Idaho, 83704
GSK Investigational Site
Braintree, Massachusetts, 02184
GSK Investigational Site
Charleston, South Carolina, 29407
GSK Investigational Site
Charlotte, North Carolina, 28209
GSK Investigational Site
Clementon, New Jersey, 08021
GSK Investigational Site
Colorado Springs, Colorado, 80904
GSK Investigational Site
Conshohocken, Pennsylvania, 19428
GSK Investigational Site
East Providence, Rhode Island, 02914
GSK Investigational Site
El Centro, California, 92243
GSK Investigational Site
Eugene, Oregon, 97401
GSK Investigational Site
Gaithersburg, Maryland, 20877
GSK Investigational Site
Greensboro, North Carolina, 27401
GSK Investigational Site
Houston, Texas, 77007
GSK Investigational Site
Jacksonville, Florida, 32216
GSK Investigational Site
Lafayette, Indiana, 47905
GSK Investigational Site
Leesburg, Florida, 34748
GSK Investigational Site
Little Rock, Arkansas, 72223
GSK Investigational Site
Los Angeles, California, 90048
GSK Investigational Site
Marietta, Georgia, 30060
GSK Investigational Site
Memphis, Tennessee, 38119
GSK Investigational Site
Miami, Florida, 33125
GSK Investigational Site
Miami, Florida, 33156
GSK Investigational Site
Mount Kisco, New York, 10549
GSK Investigational Site
Nashua, New Hampshire, 03060
GSK Investigational Site
New York, New York, 10021
GSK Investigational Site
New York, New York, 10024
GSK Investigational Site
Norwich, Connecticut, 06360
GSK Investigational Site
Oklahoma City, Oklahoma, 73118
GSK Investigational Site
Orlando, Florida, 32806
GSK Investigational Site
Overland Park, Kansas, 66211
GSK Investigational Site
Philadelphia, Pennsylvania, 19104
GSK Investigational Site
Philadelphia, Pennsylvania, 19115
GSK Investigational Site
Prairie Village, Kansas, 66206
GSK Investigational Site
Princeton, New Jersey, 08540
GSK Investigational Site
Raleigh, North Carolina, 27609
GSK Investigational Site
Redlands, California, 92374
GSK Investigational Site
Rockville, Maryland, 20852
GSK Investigational Site
Salt Lake City, Utah, 84107
GSK Investigational Site
San Antonio, Texas, 78229-3815
GSK Investigational Site
Santa Ana, California, 92705
GSK Investigational Site
Sebring, Florida, 33870
GSK Investigational Site
St. Petersburg, Florida, 33710
GSK Investigational Site
West Palm Beach, Florida, 33407
About this study
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
Major Depressive Disorder (MDD) Study in Elderly Outpatients
- Being tested
- Paroxetine CR
- Keywords
- Elderly, Major Depressive Disorder, MDD
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paroxetine CRDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to the week 10 last observation carried forward endpoint in the 17-item HAM-D total score.
Measured: 10 Weeks
Secondary outcomes (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.
Measured: 10 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2003 (estimated)
- Study startJun 2003
- Primary completionJan 2005
- Study completionJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Depressive Disorder, MajorStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 560 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00067444
- Sponsor's protocol ID
- 29060/874
- Status last verified
- Aug 2016
- First submitted
- 19 Aug 2003
- Last updated
- 1 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00067444
- Acronym / sponsor ID
- 29060/874
- Keywords
- Elderly, Major Depressive Disorder, MDD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 560 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Jun 2003
- Primary completion
- Jan 2005 (actual)
- Study completion
- Jan 2005 (actual)
- First posted
- 21 Aug 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Major Depressive Disorder (MDD) Study in Elderly Outpatients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paroxetine CR | Drug | – |
Primary outcome
Change from baseline to the week 10 last observation carried forward endpoint in the 17-item HAM-D total score.
Time frame: 10 Weeks
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2016.
- Results publicationPitts 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
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
46 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Paroxetine CR in people with Depressive Disorder, Major and Major Depressive Disorder (MDD), run by GlaxoSmithKline at 46 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 46 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline to the week 10 last observation carried forward endpoint in the 17-item HAM-D total score. (time frame: 10 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00067444, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2016.