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

November 9, 2007 updated by: Epix Pharmaceuticals, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

330

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
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.
Placebo Comparator: 2
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Side effects during and immediately following the treatment period
Time Frame: assessed throughout study
assessed throughout study
changes from baseline on the Hamilton Anxiety Rating (HAM-A) scale
Time Frame: change from baseline through end of study
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
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
change from baseline through end of study
responder and remission rates
Time Frame: change from baseline through end of study
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
change from baseline through end of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Epix Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

March 13, 2007

First Submitted That Met QC Criteria

March 15, 2007

First Posted (Estimate)

March 16, 2007

Study Record Updates

Last Update Posted (Estimate)

November 14, 2007

Last Update Submitted That Met QC Criteria

November 9, 2007

Last Verified

November 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EPX-CP-020

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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