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

Sponsored by:	Epix Pharmaceuticals, Inc.
Information provided by:	Epix Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00448292

Purpose

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.

Condition	Intervention	Phase
Major Depressive Disorder (MDD)	Drug: PRX-00023 Drug: Placebo for PRX-00023	Phase II

MedlinePlus related topics: Depression

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of PRX-00023 in Patients With Major Depressive Disorder.

Further study details as provided by Epix Pharmaceuticals, Inc.:

Primary Outcome Measures:

Change from baseline on the Montgomery-Asberg Depression Rating Scale (MADRS). [ Time Frame: change from baseline through end of study ]

Secondary Outcome Measures:

Side effects during and immediately following the treatment period [ Time Frame: assessed throughout study ]
changes from baseline on the Hamilton Anxiety Rating (HAM-A) scale [ Time Frame: change from baseline through end of study ]
changes from baseline on the Quick Inventory of Depressive Symptomatology-self report (QIDS-SR) [ Time Frame: change from baseline through end of study ]
changes from baseline on the Clinical Global Impressions (CGI) scale [ Time Frame: change from baseline through end of study ]
responder and remission rates [ Time Frame: change from baseline through end of study ]
changes from baseline on the Changes in Sexual Function (CSFQ) scale. [ Time Frame: change from baseline through end of study ]

Estimated Enrollment:	330
Study Start Date:	March 2007
Study Completion Date:	November 2007

Arms	Assigned Interventions
1: Experimental PRX-00023 taken twice daily, escalating from 40 mg to 80 mg to 120 mg	Drug: PRX-00023 Doses taken two times per day. dose increased at scheduled intervals from 40 mg to 80 mg to 120 mg.
2: Placebo Comparator Placebo taken twice daily, escalating from 40 mg to 80 mg to 120 mg	Drug: Placebo for PRX-00023 Doses taken two times per day. dose increased at scheduled intervals from 40 mg to 80 mg to 120 mg.

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00448292

Locations

United States, Arizona
Vista Medical Research, Inc.
Mesa, Arizona, United States, 85206
United States, California
Synergy Clinical Research Center
National City, California, United States, 91950
Excell Research
Oceanside, California, United States, 92056
AVI Clinical Research
Torrance, California, United States, 90505
Pharmacology Research Institute
Los Alamitos, California, United States, 90720
Pacific Clinical Research Medical Group
Upland, California, United States, 91786
Pacific Clinical Research Medical Group
Riverside, California, United States, 92506
Pharmacology Research Institute
Encino, California, United States, 91316
United States, District of Columbia
GWU Clinical Psychiatric Research Center
Washington, District of Columbia, United States, 20037
United States, Florida
CNS Healthcare of Jacksonville
Jacksonville, Florida, United States, 32216
United States, Georgia
Atlanta Institute of Medicine and Research
Atlanta, Georgia, United States, 30328
United States, Illinois
Chicago Research Center, Inc.
Chicago, Illinois, United States, 60634
United States, Kansas
Vince and Associates Clinical Research
Overland Park, Kansas, United States, 66212
United States, Louisiana
Brentwood Research Institute
Shreveport, Louisiana, United States, 71101
United States, North Carolina
Piedmont Neuropsychiatry
Charlotte, North Carolina, United States, 28216
United States, Pennsylvania
University of Pennsylvannia
Philadelphia, Pennsylvania, United States, 19140
United States, South Carolina
SE Health Consultants, LLC
Charleston, South Carolina, United States, 29407
United States, Texas
R/D Clinical Research, Inc.
Lake Jackson, Texas, United States, 77566
University of Texas - Southwestern Medical Center
Dallas, Texas, United States, 75235
United States, Washington
Northwest Clinical Research Center
Bellevue, Washington, United States, 98004
Summit Research Network
Seattle, Washington, United States, 98104

Sponsors and Collaborators

Epix Pharmaceuticals, Inc.

More Information

Study ID Numbers:	EPX-CP-020
Study First Received:	March 13, 2007
Last Updated:	November 9, 2007
ClinicalTrials.gov Identifier:	NCT00448292
Health Authority:	United States: Food and Drug Administration

Keywords provided by Epix Pharmaceuticals, Inc.:

Depression
Major Depressive Disorder
Major Depression
MDD

Study placed in the following topic categories:

Depression
Mental Disorders
Mood Disorders

Depressive Disorder, Major
Depressive Disorder
Behavioral Symptoms

Additional relevant MeSH terms:

Pathologic Processes
Disease

ClinicalTrials.gov processed this record on January 14, 2009