NCT00839176

Brief 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). The secondary objectives of this trial are to evaluate the safety and quality of life in subjects with MDD receiving RX-10100 treatment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
118

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2009

Shorter than P25 for phase_2

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 5, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 9, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

November 19, 2013

Status Verified

November 1, 2013

Enrollment Period

8 months

First QC Date

February 5, 2009

Last Update Submit

November 18, 2013

Conditions

Major Depressive Disorder (MDD)

Keywords

Major Depressive Disorder (MDD)SerdaxinRexahn

Outcome Measures

Primary Outcomes (1)

  • Change from baseline at 8 weeks on the Montgomery-Asberg Depression Rating Scale (MADRS)

    8 weeks

Secondary Outcomes (4)

  • Changes from baseline on the HAM-D

    8 weeks

  • Changes from baseline on the QIDS-SR

    8 weeks

  • CGI-I scale at the end of treatment,

    8 weeks

  • Side effects during and immediately following the treatment period

    8 weeks

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Placebo (w/o API)

Drug: RX-10100

2

EXPERIMENTAL

5mg dose of RX-10100

Drug: RX-10100

3

EXPERIMENTAL

10mg dose of RX-10100

Drug: RX-10100

4

EXPERIMENTAL

15 mg dose of RX-10100

Drug: RX-10100

Interventions

RX-10100DRUG

Extended-release tablet, 5\~15mg, twice day (morning \& evening) at least 30 min before meal, 8 weeks

Also known as: Serdaxin
234Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • +22 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Unknown Facility

Denver, Colorado, 80239, United States

Location

Unknown Facility

Atlanta, Georgia, 30308, United States

Location

Unknown Facility

Rockville, Maryland, 20852, United States

Location

Related Publications (1)

  • 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.

    PMID: 22203317DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

RX-10100

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Study Officials

  • Christine Peterson, PhD

    Rexahn Pharmaceuticals, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2009

First Posted

February 9, 2009

Study Start

January 1, 2009

Primary Completion

September 1, 2009

Study Completion

October 1, 2009

Last Updated

November 19, 2013

Record last verified: 2013-11

Locations

US(3)