Major Depressive Disorder (MDD)Phase 2NCT00839176
Efficacy Study of RX-10100 to Treat Major Depressive Disorder (MDD)
A Phase 2 study testing RX-10100 in people with Major Depressive Disorder (MDD), run by Rexahn Pharmaceuticals, Inc. at 3 sites in United States.
Trial summary
The primary objective of this Phase IIa trial is to determine the effective dose and treatment period for an upcoming RX-10100 Phase IIb trial in subjects with major depression disorder (MDD). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder (MDD)
- 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
- 118 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2009to Oct 2009
- Phase
- Phase 2
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
- Males or females between 18 and 65 years old
- Diagnosis of MDD using DSM-IV criteria
- Have a score of 20 or more on the HAM-D-17
- Have a score of 4 or more on the CGI-S
- Written informed consent obtained
- Have a negative serum (P-HCG) pregnancy test at screening (for all women)
- Female subjects must meet one of the following criteria: (a) Be surgically sterile or (b) Agree that, if sexually active they will use oral contraceptives, double barrier contraception (E.g., condom with spermicide), intrauterine device, or other method approved by the sponsor.
Who cannot join
- Have a BMI > 40 or < 18
- Unstable angina pectoris
- History of myocardial infarction, stroke, or life-threatening arrhythmia within the prior 6 months
- Uncontrolled atrial fibrillation/flutter at screening
- Severe chronic or acute liver disease; history of moderate or severe hepatic impairment
- Clinically significant chronic hematological disease which may lead to priapism, such as sickle cell anemia and leukemia
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- Bleeding disorder
- Resting hypotension or hypertension
- History of malignancy (cancers) within the past 5 years (other than squamous or basal cell skin cancer)
- NYHA Class III or IV heart failure
- Substance abuse/dependence within the past 6 months
- Significant suicidal ideation based on the C-SSRS
- Other current nondepressive Axis I disorders
- Depressive episode duration of less than 1 month or greater than 9 months
- Bipolar disorder
- Dysthmic disorder
- Borderline personality disorder
- Psychotic disorder/current psychotic features
- Any abnormal findings on the screening ECG judged clinically significant by the Investigator
- Any medical condition that is not stabilized or is anticipated to require hospitalization within 6 months, in the opinion of the Investigator
- Any history of cholestatic jaundice or liver cirrhosis
- Hyper- or hypothyroidism unless the subject has received a stable dose of thyroid medication for at least 3 months prior to the screening visit
- Women, who are breast-feeding, have been lactating within 3 months prior to screening
- Concurrent psychotherapy
- Subjects who have received any other investigational drug (including placebo) within 30 days before Visit 1
- Use of any treatment for MDD within 7 days of Visit 1 (14 days for fluoxetine) and during the study other than the study medication
- Use of antidepressants, anxiolytics, or other psychoactive drugs within 14 days of Visit 1 and during the study
- Concomitant use of antibiotics in the penicillin class (for the reduction of the potential for any additive or synergistic hepatotoxicity)
- A positive urine drug screen
- Elevation of AST and/or ALT > 3 times the upper limit of normal (ULN)
- Diabetic subjects with an HbAlc ≥ 12%
- Any abnormal screening laboratory values judged clinically significant by the Investigator
- Previous nonresponse or hypersensitivity to two or more trials of antidepressant medication given in adequate doses and duration for the treatment of symptoms present in the current illness
- Subjects with known hypersensitivity to any antibiotic in the penicillin class
- Subjects who are illiterate or unable to understand the questionnaires
- Subjects who, in the opinion of the investigator, would be non-compliant with the visit schedule of study procedures
- Subjects who pose potential harm to others
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Study site
Atlanta, Georgia, 30308
Study site
Denver, Colorado, 80239
Study site
Rockville, Maryland, 20852
About this study
Official title: A Double-blinded, Randomized, Placebo-controlled, Dose-Exploring Study of RX-10100 When Given for Eight Consecutive Weeks to Subjects With Major Depression Disorder (MDD)
The primary objective of this Phase IIa trial is to determine the effective dose and treatment period for an upcoming RX-10100 Phase IIb trial in subjects with major depression disorder (MDD). The secondary objectives of this trial are to evaluate the safety and quality of life in subjects with MDD receiving RX-10100 treatment.
- Conditions
- Major Depressive Disorder (MDD)
- Being tested
- RX-10100
- Keywords
- Major Depressive Disorder (MDD), Serdaxin, Rexahn
- 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.
RX-10100Drug
Also called Serdaxin
Extended-release tablet, 5~15mg, twice day (morning \& evening) at least 30 min before meal, 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo (w/o API) Receives: Drug: RX-10100 |
| 2 | Experimental | 5mg dose of RX-10100 Receives: Drug: RX-10100 |
| 3 | Experimental | 10mg dose of RX-10100 Receives: Drug: RX-10100 |
| 4 | Experimental | 15 mg dose of RX-10100 Receives: Drug: RX-10100 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline at 8 weeks on the Montgomery-Asberg Depression Rating Scale (MADRS)
Measured: 8 weeks
Secondary outcomes (4)
Changes from baseline on the HAM-D
Measured: 8 weeks
Changes from baseline on the QIDS-SR
Measured: 8 weeks
CGI-I scale at the end of treatment,
Measured: 8 weeks
Side effects during and immediately following the treatment period
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 posted9 Feb 2009 (estimated)
- Study startJan 2009
- Primary completionSep 2009
- Study completionOct 2009
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 Major Depressive Disorder (MDD)Studies 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
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rexahn Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christine Peterson, PhD, Study director, Rexahn Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00839176
- Sponsor's protocol ID
- RX-10100-P2A-002
- Status last verified
- Nov 2013
- First submitted
- 5 Feb 2009
- Last updated
- 19 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Riesenberg R, Rosenthal J, Moldauer L, Peterson C. Results of a proof-of-concept, dose-finding, double-blind, placebo-controlled study of RX-10100 (Serdaxin(R)) in subjects with major depressive disorder. Psychopharmacology (Berl). 2012 Jun;221(4):601-10. doi: 10.1007/s00213-011-2604-x. Epub 2011 Dec 28.
PubMed 22203317