Depressive Disorder, MajorPhase 2NCT00057213
An 8 Week Study Of Depression In Adults Diagnosed With Major Depressive Disorder
A Phase 2 study testing Radafaxine in people with Depressive Disorder, Major, run by GlaxoSmithKline at 21 sites in United States.
Trial summary
A Placebo Controlled Study Evaluating Efficacy, Safety and Tolerability of Medication in Patients with Major Depressive Disorder (MDD) Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Depressive Disorder, Major
- What is being tested?
- Radafaxine
- How many people
- 367 participants
- Where
- 21 sitesUnited States
- Study dates
- Mar 2003to Apr 2007
- Phase
- Phase 2
- 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 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of Major Depressive Disorder (MDD)
- Duration of current depressive episode 12 weeks - 24 months
- Patients can read and write at a level sufficient to provide a signed consent
- If female, patients must be practicing an acceptable method of birth control
Who cannot join
- Patients have other psychiatric disorders that would affect patient's response to treatment
- Patients have not responded to two or more adequate courses of antidepressant therapy
- Patients cannot be currently abusing illicit drugs or alcohol
- Patients are not currently receiving psychotherapy
- Patients have received electroconvulsive therapy within 6 months prior to screening
- Patients are pregnant or lactating
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
GSK Investigational Site
Austin, Texas, 78756
GSK Investigational Site
Brockton, Massachusetts, 2301
GSK Investigational Site
Chapel Hill, North Carolina, 27514
GSK Investigational Site
Eugene, Oregon, 97401
GSK Investigational Site
Florence, Kentucky, 41042
GSK Investigational Site
Galveston, Texas, 77555
GSK Investigational Site
Garden Grove, California, 92845
GSK Investigational Site
Irvine, California, 92618
GSK Investigational Site
Lake Jackson, Texas, 77566
GSK Investigational Site
Lyndhurst, Ohio, 44124
GSK Investigational Site
Miami, Florida, 33173
GSK Investigational Site
National City, California, 91950
GSK Investigational Site
New York, New York, 10021
GSK Investigational Site
Peoria, Arizona, 85381 - 4828
GSK Investigational Site
Philadelphia, Pennsylvania, 19106
GSK Investigational Site
Raleigh, North Carolina, 27609
GSK Investigational Site
Salt Lake City, Utah, 84107
GSK Investigational Site
Scottsdale, Arizona, 85251
GSK Investigational Site
Springfield, Illinois, 62702
GSK Investigational Site
Terre Haute, Indiana, 47802
GSK Investigational Site
Winter Park, Florida, 32789
About this study
Official title: A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Flexible-Dose Study Evaluating Efficacy, Safety, and Tolerability of Once-Daily Oral GW353162 (20-40-60mg) Versus Placebo in Subjects With Major Depressive Disorder Over an Eight-Week Treatment Period.
A Placebo Controlled Study Evaluating Efficacy, Safety and Tolerability of Medication in Patients with Major Depressive Disorder (MDD)
- Conditions
- Depressive Disorder, Major
- Being tested
- Radafaxine
- Keywords
- Major Depressive Disorder (MDD),, Flexible, GW353162,
- 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.
RadafaxineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Montgomery-Asberg Depression Rating Scale (MADRS) after 8 weeks of treatment
Measured: 8 Weeks
Secondary outcomes (1)
Change in the MADRS score at other timepoints; change in Clinical Global Impression; percentage of remitters and responders based on the MADRS; change in disability, motivation, energy, fatigue and pain;incidence of adverse events over course of study;
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2003 (estimated)
- Study startMar 2003
- Primary completionApr 2007
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 367 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
- NCT00057213
- Sponsor's protocol ID
- OHB20002
- Status last verified
- Apr 2015
- First submitted
- 27 Mar 2003
- Last updated
- 16 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Flexible-Dose Study Evaluating Efficacy, Safety, and Tolerability of Once-Daily Oral GW353162 (20-40-60mg) Versus Placebo in Subjects With Major Depressive Disorder Over an Eight-Week Treatment Period.
- ClinicalTrials.gov ID
- NCT00057213
- Acronym / sponsor ID
- OHB20002
- Conditions
- Depressive Disorder, Major
- Keywords
- Major Depressive Disorder (MDD),, Flexible, GW353162,
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 367 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Mar 2003
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 28 Mar 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.
A Placebo Controlled Study Evaluating Efficacy, Safety and Tolerability of Medication in Patients with Major Depressive Disorder (MDD)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Diagnosis of Major Depressive Disorder (MDD)
- Duration of current depressive episode 12 weeks - 24 months
- Patients can read and write at a level sufficient to provide a signed consent
- If female, patients must be practicing an acceptable method of birth control
Key exclusion criteria (6 listed)
- Patients have other psychiatric disorders that would affect patient's response to treatment
- Patients have not responded to two or more adequate courses of antidepressant therapy
- Patients cannot be currently abusing illicit drugs or alcohol
- Patients are not currently receiving psychotherapy
- Patients have received electroconvulsive therapy within 6 months prior to screening
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 |
|---|---|---|
| Radafaxine | Drug | – |
Primary outcome
Change in the Montgomery-Asberg Depression Rating Scale (MADRS) after 8 weeks of treatment
Time frame: 8 Weeks
1 secondary outcome
Change in the MADRS score at other timepoints; change in Clinical Global Impression; percentage of remitters and responders based on the MADRS; change in disability, motivation, energy, fatigue and pain;incidence of adverse events over course of study;
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 16 Apr 2015.
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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
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Radafaxine in people with Depressive Disorder, Major, run by GlaxoSmithKline at 21 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 16 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 in the Montgomery-Asberg Depression Rating Scale (MADRS) after 8 weeks of treatment (time frame: 8 Weeks). 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 16 Apr 2015.