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

Rexahn Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Major Depressive Disorder

Treatments: Drug: RX-10100

Study type: Interventional

Funder types: Industry

Identifiers

NCT01273376

2010MDD01

Details and patient eligibility

About

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

Enrollment: 314 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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314 participants in 3 patient groups, including a placebo group

RX-10100 high dose

Experimental group

Description:

RX-10100 Study drug is to be given orally, in tablet form, twice daily, for 8 weeks

Treatment:

Drug: RX-10100

RX-10100 low dose

Experimental group

Description:

RX-10100 Study drug is to be given orally, in tablet form, twice daily, for 8 weeks

Treatment:

Drug: RX-10100

Placebo

Placebo Comparator group

Description:

Matching placebo is to be given orally, in tablet form, twice daily, for 8 weeks

Treatment:

Drug: RX-10100