Major Depressive DisorderPhase 4NCT00049972
Major Depressive Disorder Study In Adults
A Phase 4 study testing paroxetine CR in people with Major Depressive Disorder, run by GlaxoSmithKline at 71 sites in United States.
Trial summary
A study to obtain safety and tolerability data Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- paroxetine CR
- How many people
- 646 participants
- Where
- 71 sitesUnited States
- Study dates
- Sep 2002to Sep 2003
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient must have primary diagnosis of Major Depressive Disorder (MDD).
- Discontinued a selective serotonin reuptake inhibitor (SSRI)or serotonin-norepinephrine reuptake inhibitor (SNRI) regimen due to intolerability.
- Minimum time frame between last dose of previous antidepressant and initiation of study drug is one week.
- Maximum time frame between last dose of prior antidepressant and initiation of study drug is 2 months.
Who cannot join
- Patient has previously been treated with the study drug.
- Is experiencing an adverse event attributed to previous SSRI/SNRI use that has not been resolved at least one week prior to Baseline Visit.
- Has a history of seizure disorder.
- Has met criteria for substance abuse or dependence within 6 months prior to Baseline Visit.
- Currently using an antidepressant.
- Currently pregnant.
Trial locations and contacts
71 sites in 1 country.
71 sites in 1 country
United States71 sites
GSK Clinical Trial Call Center
Anaheim, California, 92801
GSK Clinical Trial Call Center
Anaheim Hills, California, 92807
GSK Clinical Trial Call Center
Atlanta, Georgia, 30312
GSK Clinical Trial Call Center
Bartlett, Tennessee, 38134
GSK Clinical Trial Call Center
Bellflower, California, 90706
GSK Clinical Trial Call Center
Birmingham, Alabama, 35209
GSK Clinical Trial Call Center
Birmingham, Alabama, 83704
GSK Clinical Trial Call Center
Blackwood, New Jersey, 08012
GSK Clinical Trial Call Center
Boynton Beach, Florida, 33426
GSK Clinical Trial Call Center
Carrboro, North Carolina, 27510
GSK Clinical Trial Call Center
Cary, North Carolina, 27511
GSK Clinical Trial Call Center
Cerritos, California, 90703
GSK Clinical Trial Call Center
Cincinnati, Ohio, 45219
GSK Clinical Trial Call Center
Cincinnati, Ohio, 45224
GSK Clinical Trial Call Center
Cleveland, Ohio, 44106
GSK Clinical Trial Call Center
Clovis, California, 93611
GSK Clinical Trial Call Center
Colorado Springs, Colorado, 80904
GSK Clinical Trial Call Center
Conroe, Texas, 77384
GSK Clinical Trial Call Center
Cordova, Tennessee, 38018
GSK Clinical Trial Call Center
Corsicana, Texas, 75110
GSK Clinical Trial Call Center
Dallas, Texas, 72505
GSK Clinical Trial Call Center
Delray Beach, Florida, 33484
GSK Clinical Trial Call Center
DeSoto, Texas, 75115
GSK Clinical Trial Call Center
Downingtown, Pennsylvania, 19335
GSK Clinical Trial Call Center
Encino, California, 91316
GSK Clinical Trial Call Center
Eugene, Oregon, 97404
GSK Clinical Trial Call Center
Excelsior Springs, Missouri, 64024
GSK Clinical Trial Call Center
Fairfield, Alabama, 35064
GSK Clinical Trial Call Center
Fort Myers, Florida, 33901
GSK Clinical Trial Call Center
Fort Worth, Texas, 76137
GSK Clinical Trial Call Center
Galveston, Texas, 77555
GSK Clinical Trial Call Center
Greenwood, Indiana, 46143
GSK Clinical Trial Call Center
Gurnee, Illinois, 60031
GSK Clinical Trial Call Center
Idaho Falls, Idaho, 83404
GSK Clinical Trial Call Center
Independence, Ohio, 44131
GSK Clinical Trial Call Center
Kansas City, Missouri, 64132
GSK Clinical Trial Call Center
Kirkland, Washington, 98034
GSK Clinical Trial Call Center
Lafayette, Louisiana, 47905
GSK Clinical Trial Call Center
Lake Charles, Louisiana, 70601
GSK Clinical Trial Call Center
Las Vegas, Nevada, 89030
GSK Clinical Trial Call Center
Lebanon, Virginia, 24266
GSK Clinical Trial Call Center
Little Rock, Arkansas, 72111
GSK Clinical Trial Call Center
Little Rock, Arkansas, 72205
GSK Clinical Trial Call Center
Melbourne, Florida, 32955
GSK Clinical Trial Call Center
Mercerville, New Jersey, 08619
GSK Clinical Trial Call Center
Miami, Florida, 33161
GSK Clinical Trial Call Center
Mobile, Alabama, 36695
GSK Clinical Trial Call Center
New Orleans, Louisiana, 70127
GSK Clinical Trial Call Center
Ocala, Florida, 34474
GSK Clinical Trial Call Center
Oklahoma City, Oklahoma, 73112
GSK Clinical Trial Call Center
Petaluma, California, 94952
GSK Clinical Trial Call Center
Phoenix, Arizona, 85015
GSK Clinical Trial Call Center
Prince Frederick, Maryland, 20678
GSK Clinical Trial Call Center
Princeton, New Jersey, 08540
GSK Clinical Trial Call Center
Reno, Nevada, 89501
GSK Clinical Trial Call Center
Richardson, Texas, 75080
GSK Clinical Trial Call Center
Richmond, Virginia, 23230
GSK Clinical Trial Call Center
Riverside, California, 92506
GSK Clinical Trial Call Center
Sacramento, California, 95823
GSK Clinical Trial Call Center
Sacramento, California, 95825
GSK Clinical Trial Call Center
Saint Charles, Missouri, 63301
GSK Clinical Trial Call Center
San Francisco, California, 94109
GSK Clinical Trial Call Center
Selmer, Tennessee, 38375
GSK Clinical Trial Call Center
Springfield, Massachusetts, 01107
GSK Clinical Trial Call Center
St Louis, Missouri, 63128
GSK Clinical Trial Call Center
Sugar Land, Texas, 77478
GSK Clinical Trial Call Center
Temecula, California, 92591
GSK Clinical Trial Call Center
Vista, California, 92083
GSK Clinical Trial Call Center
West Valley City, Utah, 84120
GSK Clinical Trial Call Center
Wilmington, Delaware, 19803
GSK Clinical Trial Call Center
Wilmington, Delaware, 19810
About this study
Official title: An Open Label Study Assessing Paxil CR (Paroxetine CR) in Patients With Major Depressive Disorder Who Discontinued Treatment With Selective Serotonin Reuptake Inhibitors or a Selective Serotonin/Norepinephrine Reuptake Inhibitor Due to Intolerability
A study to obtain safety and tolerability data
- Conditions
- Major Depressive Disorder
- Being tested
- paroxetine CR
- Keywords
- Major Depressive Disorder Open-label discontinued
- 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.
The proportion of patients who prematurely terminated treatment due to treatment emergent adverse events
Secondary outcomes (1)
Recurrence rates of adverse events causing intolerability of previous SSRI/SNRI, Adverse event incidence rates, Mean change from baseline in the Beck Depression Inventory-II total score, Proportion of responsers based on teh CGI Global Improvement Item
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2002 (estimated)
- Study startSep 2002
- Primary completionSep 2003
- Study completionSep 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Masking
- None (open label)
- Enrolment
- 646 participants
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- GSK Clinical Trials, MD, Study chair, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00049972
- Sponsor's protocol ID
- SB29060.833
- Status last verified
- Sep 2017
- First submitted
- 18 Nov 2002
- Last updated
- 11 Sep 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Study Assessing Paxil CR (Paroxetine CR) in Patients With Major Depressive Disorder Who Discontinued Treatment With Selective Serotonin Reuptake Inhibitors or a Selective Serotonin/Norepinephrine Reuptake Inhibitor Due to Intolerability
- ClinicalTrials.gov ID
- NCT00049972
- Acronym / sponsor ID
- SB29060.833
- Conditions
- Major Depressive Disorder
- Keywords
- Major Depressive Disorder Open-label discontinued
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 646 participants
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Sep 2002
- Primary completion
- Sep 2003 (actual)
- Study completion
- Sep 2003 (actual)
- First posted
- 19 Nov 2002 (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.
A study to obtain safety and tolerability data
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient must have primary diagnosis of Major Depressive Disorder (MDD).
- Discontinued a selective serotonin reuptake inhibitor (SSRI)or serotonin-norepinephrine reuptake inhibitor (SNRI) regimen due to intolerability.
- Minimum time frame between last dose of previous antidepressant and initiation of study drug is one week.
- Maximum time frame between last dose of prior antidepressant and initiation of study drug is 2 months.
Key exclusion criteria (6 listed)
- Patient has previously been treated with the study drug.
- Is experiencing an adverse event attributed to previous SSRI/SNRI use that has not been resolved at least one week prior to Baseline Visit.
- Has a history of seizure disorder.
- Has met criteria for substance abuse or dependence within 6 months prior to Baseline Visit.
- Currently using an antidepressant.
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
The proportion of patients who prematurely terminated treatment due to treatment emergent adverse events
1 secondary outcome
Recurrence rates of adverse events causing intolerability of previous SSRI/SNRI, Adverse event incidence rates, Mean change from baseline in the Beck Depression Inventory-II total score, Proportion of responsers based on teh CGI Global Improvement Item
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 11 Sep 2017.
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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, MD study chair
GlaxoSmithKline
71 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing paroxetine CR in people with Major Depressive Disorder, run by GlaxoSmithKline at 71 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 4 inclusion and 6 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 11 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 71 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
The proportion of patients who prematurely terminated treatment due to treatment emergent adverse events. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Sep 2017.