A Efficacy Study of PRX-00023 in Patients With Major Depressive Disorder

Epix Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Major Depressive Disorder (MDD)

Treatments: Drug: PRX-00023; Drug: Placebo for PRX-00023

Study type: Interventional

Funder types: Industry

Identifiers

NCT00448292

EPX-CP-020

Details and patient eligibility

About

The purpose of this randomized, double-blind, placebo-controlled study is to assess the safety and efficacy of PRX-00023 in patients with major depressive disorder.

Full description

Patients with major depressive disorder who meet all of the eligibility criteria will be randomly assigned to receive twice daily doses of either placebo or PRX-00023. Study drug will be taken for up to approximately 9 weeks. Patients will have periodic office visits for the purpose of monitoring safety and tolerability, as well as efficacy assessments.

Enrollment: 330 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Diagnosis of major depressive disorder

Key Exclusion Criteria:

• Females who are pregnant or nursing
• Electroconvulsive therapy within previous year
• Type 1 diabetes or uncontrolled type 2 diabetes
• HIV, Hepatitis B or Hepatitis C
• Use of illegal drugs, history of drug abuse, and/or alcohol dependence
• Clinically significant abnormal lab results

Other protocol-defined eligibility criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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330 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

PRX-00023 taken twice daily, escalating from 40 mg to 80 mg to 120 mg

Treatment:

Drug: PRX-00023

2

Placebo Comparator group

Description:

Placebo taken twice daily, escalating from 40 mg to 80 mg to 120 mg

Treatment:

Drug: Placebo for PRX-00023