A Efficacy Study of PRX-00023 in Patients With Major Depressive Disorder
- Conditions
- Major Depressive Disorder (MDD)
- Interventions
- Drug: PRX-00023Drug: Placebo for PRX-00023
- Registration Number
- NCT00448292
- Lead Sponsor
- Epix Pharmaceuticals, Inc.
- Brief Summary
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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 330
- Diagnosis of major depressive disorder
Key
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 PRX-00023 PRX-00023 taken twice daily, escalating from 40 mg to 80 mg to 120 mg 2 Placebo for PRX-00023 Placebo taken twice daily, escalating from 40 mg to 80 mg to 120 mg
- Primary Outcome Measures
Name Time Method Change from baseline on the Montgomery-Asberg Depression Rating Scale (MADRS). change from baseline through end of study
- Secondary Outcome Measures
Name Time Method Side effects during and immediately following the treatment period assessed throughout study changes from baseline on the Hamilton Anxiety Rating (HAM-A) scale change from baseline through end of study changes from baseline on the Quick Inventory of Depressive Symptomatology-self report (QIDS-SR) change from baseline through end of study changes from baseline on the Clinical Global Impressions (CGI) scale change from baseline through end of study responder and remission rates change from baseline through end of study changes from baseline on the Changes in Sexual Function (CSFQ) scale. change from baseline through end of study
Trial Locations
- Locations (19)
AVI Clinical Research
🇺🇸Torrance, California, United States
Vince and Associates Clinical Research
🇺🇸Overland Park, Kansas, United States
University of Texas - Southwestern Medical Center
🇺🇸Dallas, Texas, United States
University of Pennsylvannia
🇺🇸Philadelphia, Pennsylvania, United States
R/D Clinical Research, Inc.
🇺🇸Lake Jackson, Texas, United States
SE Health Consultants, LLC
🇺🇸Charleston, South Carolina, United States
Summit Research Network
🇺🇸Seattle, Washington, United States
Northwest Clinical Research Center
🇺🇸Bellevue, Washington, United States
Pharmacology Research Institute
🇺🇸Los Alamitos, California, United States
Vista Medical Research, Inc.
🇺🇸Mesa, Arizona, United States
Synergy Clinical Research Center
🇺🇸National City, California, United States
Pacific Clinical Research Medical Group
🇺🇸Upland, California, United States
Excell Research
🇺🇸Oceanside, California, United States
GWU Clinical Psychiatric Research Center
🇺🇸Washington, District of Columbia, United States
CNS Healthcare of Jacksonville
🇺🇸Jacksonville, Florida, United States
Atlanta Institute of Medicine and Research
🇺🇸Atlanta, Georgia, United States
Chicago Research Center, Inc.
🇺🇸Chicago, Illinois, United States
Piedmont Neuropsychiatry
🇺🇸Charlotte, North Carolina, United States
Brentwood Research Institute
🇺🇸Shreveport, Louisiana, United States