Safety and Efficacy of RX-10100 to Treat Major Depressive Disorder

Brief Summary

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).

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
  • Study Primary Completion Date: September 2011

Interventions Used in this Clinical Trial

  • Drug: RX-10100
    • Extended-release tablet, taken twice daily for 8 weeks

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: RX-10100 high dose
    • RX-10100 Study drug is to be given orally, in tablet form, twice daily, for 8 weeks
  • Experimental: RX-10100 low dose
    • RX-10100 Study drug is to be given orally, in tablet form, twice daily, for 8 weeks
  • Placebo Comparator: Placebo
    • Matching placebo is to be given orally, in tablet form, twice daily, for 8 weeks

Outcome Measures for this Clinical Trial

Primary Measures

  • Change from baseline in the Montgomery-Asberg Depression Rating Scale (MADRS)at week 9
    • Time Frame: 8 weeks
      Safety Issue?: No

Secondary Measures

  • Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) at weeks 3, 5, and 7
    • Time Frame: 8 weeks
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria

• Moderate to severe MDD as determined by the DSM-IV-TR Axis 1 Disorders and by the Montgomery Asberg Depression Rating Scale (MADRS).

Exclusion Criteria

  • 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • Rexahn Pharmaceuticals, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Christine Peterson, Ph.D, Study Director, Rexahn Pharmaceuticals, Inc.

Source

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT01273376