Major Depressive DisorderPhase 2MDDNCT01273376
Safety and Efficacy of RX-10100 to Treat Major Depressive Disorder
A Phase 2 study testing RX-10100 in people with Major Depressive Disorder, run by Rexahn Pharmaceuticals, Inc. at 44 sites in United States.
Trial summary
The purpose of this study is to determine whether RX-10100 are effective in the treatment of Major Depressive Disorder (MDD). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- RX-10100
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 314 participants
- Where
- 44 sitesUnited States
- Study dates
- Dec 2010to Oct 2011
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Moderate to severe MDD as determined by the DSM-IV-TR Axis 1 Disorders and by the Montgomery Asberg Depression Rating Scale (MADRS).
Who cannot join
- Women who are pregnant, women who will be breastfeeding during the study, and women with childbearing potential who are not willing to practice a reliable method of birth control
- Depressive episode duration of less than 1 month
- Lifetime history of any psychotic disorders
- Anxiety disorders
- Significant suicidality
- Clinically significant medical conditions
Trial locations and contacts
44 sites in 1 country.
44 sites in 1 country
United States44 sites
Rexahn Investigative Site
Albuquerque, New Mexico, 87109
Rexahn Investigative site
Allentown, Pennsylvania, 18103
Rexahn Investigative Site
Anderson, South Carolina, 29621
Rexahn Investigative Site -2
Atlanta, Georgia, 30328
Rexahn Investigative Site
Atlanta, Georgia, 30328
Rexahn Investigative Site
Austin, Texas, 78756
Rexahn Investigative Site (2)
Bellevue, Washington, 98007
Rexahn Investigative Site
Bellevue, Washington, 98007
Rexahn Investigative Site
Brooksville, Florida, 34601
Rexahn Investigative Site
Cerritos, California, 90703
Rexahn Investigative site
Cherry Hill, New Jersey, 08002
Rexahn Investigative Site
Cincinnati, Ohio, 45227
Rexahn Investigative site
Dallas, Texas, 75231
Rexahn Investigative Site
Dallas, Texas, 75390
Rexahn Investigative Site
Denver, Colorado, 82039
Rexahn Investigative Site
Escondido, California, 92025
Rexahn Investigative Site
Fresh Meadows, New York, 11366
Rexahn Investigative Site
Gainesville, Florida, 32607
Rexahn Investigative site
Garfield Heights, Ohio, 44125
Rexahn Investigative Site
Jacksonville, Florida, 32216
Rexahn Investigative Sites
Lake Jackson, Texas, 77566
Rexahn Investigative Site
Las Vegas, Nevada, 89146
Rexahn Investigative Site
Los Angeles, California, 90024
Rexahn Investigative Site
Media, Pennsylvania, 19063
Rexahn Investigative Site
Memphis, Tennessee, 38119
Rexahn Investigative Site
Miami Beach, Florida, 33139
Rexahn Investigative Site
National City, California, 91950
Rexahn Investigative Site
New York, New York, 10021
Rexahn Investigative Site
Novi, Michigan, 48377
Rexahn Investigative Site
Oak Brook, Illinois, 60523
Rexahn Investigative Site
Oceanside, California, 92056
Rexahn Investigative Site
Oklahoma City, Oklahoma, 73103
Rexahn Investigative Site
Orange, California, 92868
Rexahn Investigative Site
Orem, Utah, 84058
Rexahn Investigative Site
Orlando, Florida, 32806
Rexahn Investigative Site
Owensboro, Kentucky, 42301
Rexahn Investigative Site
Richmond, Virginia, 23284
Rexahn Investigative Site
San Antonio, Texas, 78229
Rexahn Investigative Site
San Diego, California, 92123
Rexahn Investigative Site
Scranton, Pennsylvania, 18503
Rexahn Investigative Site
St. Petersburg, Florida, 33709
Rexahn Investigative Site
Tampa, Florida, 33606
Rexahn Investigative Site
The Woodlands, Texas, 77381
Rexahn Investigative Site
Vernon Hills, Illinois, 60061
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 2 Study of RX-10100 in Subjects With Major Depressive Disorder.
The purpose of this study is to determine whether RX-10100 are effective in the treatment of Major Depressive Disorder (MDD).
- Conditions
- Major Depressive Disorder
- Being tested
- RX-10100
- Keywords
- MDD, Depression, Major Depression
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RX-10100Drug
Also called Serdaxin®
Extended-release tablet, taken twice daily for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| RX-10100 high dose | Experimental | RX-10100
Study drug is to be given orally, in tablet form, twice daily, for 8 weeks Receives: Drug: RX-10100 |
| RX-10100 low dose | Experimental | RX-10100
Study drug is to be given orally, in tablet form, twice daily, for 8 weeks Receives: Drug: RX-10100 |
| Placebo | Placebo comparator | Matching placebo is to be given orally, in tablet form, twice daily, for 8 weeks Receives: Drug: RX-10100 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the Montgomery-Asberg Depression Rating Scale (MADRS)at week 9
Measured: 8 weeks
Secondary outcomes (1)
Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) at weeks 3, 5, and 7
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2011 (estimated)
- Study startDec 2010
- Primary completionSep 2011
- Study completionOct 2011
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.
- 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
- Who is masked
- Participant, Investigator
- Enrolment
- 314 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rexahn Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christine Peterson, Ph.D, Study director, Rexahn Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01273376
- Sponsor's protocol ID
- 2010MDD01
- Acronym
- MDD
- Status last verified
- Nov 2013
- First submitted
- 6 Jan 2011
- Last updated
- 19 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 2 Study of RX-10100 in Subjects With Major Depressive Disorder.
- ClinicalTrials.gov ID
- NCT01273376
- Acronym / sponsor ID
- MDD / 2010MDD01
- Conditions
- Major Depressive Disorder
- Keywords
- MDD, Depression, Major Depression
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 314 participants (actual)
- Lead sponsor
- Rexahn Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 10 Jan 2011 (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.
The purpose of this study is to determine whether RX-10100 are effective in the treatment of Major Depressive Disorder (MDD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| RX-10100 high dose | Experimental | Drug: RX-10100RX-10100 Study drug is to be given orally, in tablet form, twice daily, for 8 weeks |
| RX-10100 low dose | Experimental | Drug: RX-10100RX-10100 Study drug is to be given orally, in tablet form, twice daily, for 8 weeks |
| Placebo | Placebo comparator | Drug: RX-10100Matching placebo is to be given orally, in tablet form, twice daily, for 8 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Moderate to severe MDD as determined by the DSM-IV-TR Axis 1 Disorders and by the Montgomery Asberg Depression Rating Scale (MADRS).
Key exclusion criteria (6 listed)
- Women who are pregnant, women who will be breastfeeding during the study, and women with childbearing potential who are not willing to practice a reliable method of birth control
- Depressive episode duration of less than 1 month
- Lifetime history of any psychotic disorders
- Anxiety disorders
- Significant suicidality
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 |
|---|---|---|
| RX-10100Also: Serdaxin®Extended-release tablet, taken twice daily for 8 weeks | Drug | Placebo, RX-10100 high dose, RX-10100 low dose |
Primary outcome
Change from baseline in the Montgomery-Asberg Depression Rating Scale (MADRS)at week 9
Time frame: 8 weeks
1 secondary outcome
Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) at weeks 3, 5, and 7
Time frame: 8 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 19 Nov 2013.
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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.
Christine Peterson, Ph.D study director
Rexahn Pharmaceuticals, Inc.
44 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 RX-10100 in people with Major Depressive Disorder, run by Rexahn Pharmaceuticals, Inc. at 44 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 1 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 19 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 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. Some participants in this study may receive a placebo. 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 from baseline in the Montgomery-Asberg Depression Rating Scale (MADRS)at week 9 (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 19 Nov 2013.