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

The purpose of this study is to determine whether RX-10100 are effective in the treatment of Major Depressive Disorder (MDD).

Completed

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Key information

Conditions

Major Depressive Disorder Behavior Behavioral Symptoms Depression Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Rexahn Investigative Site, Cerritos, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RX-10100

Drug

Extended-release tablet, taken twice daily for 8 weeks

Other names: Serdaxin®

Primary outcomes

Change from baseline in the Montgomery-Asberg Depression Rating Scale (MADRS)at week 9

Time frame: 8 weeks

Secondary outcomes

Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) at weeks 3, 5, and 7

Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Rexahn Pharmaceuticals, Inc.

Industry

Registry information

Official study title

A Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 2 Study of RX-10100 in Subjects With Major Depressive Disorder.

Acronym: MDD

Important dates

Study start: 2010
Primary completion: 2011
Study completion: 2011
First posted: Jan 10, 2011
Registry last updated: Nov 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed