Efficacy Study of RX-10100 to Treat Major Depressive Disorder (MDD)

November 18, 2013 updated by: Rexahn Pharmaceuticals, Inc.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
118

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States, 80239
    • Georgia
      • Atlanta, Georgia, United States, 30308
    • Maryland
      • Rockville, Maryland, United States, 20852

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Placebo (w/o API)
Drug: RX-10100
Extended-release tablet, 5~15mg, twice day (morning & evening) at least 30 min before meal, 8 weeks
Other Names:
  • Serdaxin
Experimental: 2
5mg dose of RX-10100
Drug: RX-10100
Extended-release tablet, 5~15mg, twice day (morning & evening) at least 30 min before meal, 8 weeks
Other Names:
  • Serdaxin
Experimental: 3
10mg dose of RX-10100
Drug: RX-10100
Extended-release tablet, 5~15mg, twice day (morning & evening) at least 30 min before meal, 8 weeks
Other Names:
  • Serdaxin
Experimental: 4
15 mg dose of RX-10100
Drug: RX-10100
Extended-release tablet, 5~15mg, twice day (morning & evening) at least 30 min before meal, 8 weeks
Other Names:
  • Serdaxin

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change from baseline at 8 weeks on the Montgomery-Asberg Depression Rating Scale (MADRS)
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Changes from baseline on the HAM-D
Time Frame: 8 weeks
8 weeks
Changes from baseline on the QIDS-SR
Time Frame: 8 weeks
8 weeks
CGI-I scale at the end of treatment,
Time Frame: 8 weeks
8 weeks
Side effects during and immediately following the treatment period
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rexahn Pharmaceuticals, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Christine Peterson, PhD, Rexahn Pharmaceuticals, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 5, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 9, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 19, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RX-10100-P2A-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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