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

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
First Received:	March 13, 2007
Last Updated:	November 9, 2007
ClinicalTrials.gov Identifier:	NCT00448292
Health Authority:	United States: Food and Drug Administration