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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01273376

Acronym

MDD

Enrollment

314

Registered

2011-01-10

Start date

2010-12-31

Completion date

2011-10-31

Last updated

2013-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Disorder

Keywords

MDD, Depression, Major Depression

Brief summary

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

Interventions

DRUGRX-10100

Extended-release tablet, taken twice daily for 8 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Change from baseline in the Montgomery-Asberg Depression Rating Scale (MADRS)at week 9	8 weeks

Secondary

Measure	Time frame
Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) at weeks 3, 5, and 7	8 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026