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

Major Depressive Disorder (MDD) Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of PRX-00023 in Patients With Major Depressive Disorder.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00448292
• Other study ID #: EPX-CP-020
• Status: Completed
• Phase: Phase 2
• First received: March 13, 2007
• Last updated: November 9, 2007
• Start date: March 2007
• Est. completion date: November 2007

Study information

• Verified date: November 2007
• Source: Epix Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 330
• Est. completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder (MDD)

Intervention

Drug:
• PRX-00023
Doses taken two times per day. dose increased at scheduled intervals from 40 mg to 80 mg to 120 mg.
• Placebo for PRX-00023
Doses taken two times per day. dose increased at scheduled intervals from 40 mg to 80 mg to 120 mg.

Locations

Country	Name	City	State
United States	Atlanta Institute of Medicine and Research	Atlanta	Georgia
United States	Northwest Clinical Research Center	Bellevue	Washington
United States	SE Health Consultants, LLC	Charleston	South Carolina
United States	Piedmont Neuropsychiatry	Charlotte	North Carolina
United States	Chicago Research Center, Inc.	Chicago	Illinois
United States	University of Texas - Southwestern Medical Center	Dallas	Texas
United States	Pharmacology Research Institute	Encino	California
United States	CNS Healthcare of Jacksonville	Jacksonville	Florida
United States	R/D Clinical Research, Inc.	Lake Jackson	Texas
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	Excell Research	Oceanside	California
United States	Vince and Associates Clinical Research	Overland Park	Kansas
United States	University of Pennsylvannia	Philadelphia	Pennsylvania
United States	Pacific Clinical Research Medical Group	Riverside	California
United States	Summit Research Network	Seattle	Washington
United States	Brentwood Research Institute	Shreveport	Louisiana
United States	AVI Clinical Research	Torrance	California
United States	Pacific Clinical Research Medical Group	Upland	California
United States	GWU Clinical Psychiatric Research Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Epix Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline on the Montgomery-Asberg Depression Rating Scale (MADRS).		change from baseline through end of study
Secondary	Side effects during and immediately following the treatment period		assessed throughout study
Secondary	changes from baseline on the Hamilton Anxiety Rating (HAM-A) scale		change from baseline through end of study
Secondary	changes from baseline on the Quick Inventory of Depressive Symptomatology-self report (QIDS-SR)		change from baseline through end of study
Secondary	changes from baseline on the Clinical Global Impressions (CGI) scale		change from baseline through end of study
Secondary	responder and remission rates		change from baseline through end of study
Secondary	changes from baseline on the Changes in Sexual Function (CSFQ) scale.		change from baseline through end of study