search
Back to results

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

Primary Purpose

Major Depressive Disorder (MDD)

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
PRX-00023
Placebo for PRX-00023
Sponsored by
Epix Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder (MDD) focused on measuring Depression, Major Depressive Disorder, Major Depression, MDD

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Vista Medical Research, Inc.
  • Pharmacology Research Institute
  • Pharmacology Research Institute
  • Synergy Clinical Research Center
  • Excell Research
  • Pacific Clinical Research Medical Group
  • AVI Clinical Research
  • Pacific Clinical Research Medical Group
  • GWU Clinical Psychiatric Research Center
  • CNS Healthcare of Jacksonville
  • Atlanta Institute of Medicine and Research
  • Chicago Research Center, Inc.
  • Vince and Associates Clinical Research
  • Brentwood Research Institute
  • Piedmont Neuropsychiatry
  • University of Pennsylvannia
  • SE Health Consultants, LLC
  • University of Texas - Southwestern Medical Center
  • R/D Clinical Research, Inc.
  • Northwest Clinical Research Center
  • Summit Research Network

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

PRX-00023 taken twice daily, escalating from 40 mg to 80 mg to 120 mg

Placebo taken twice daily, escalating from 40 mg to 80 mg to 120 mg

Outcomes

Primary Outcome Measures

Change from baseline on the Montgomery-Asberg Depression Rating Scale (MADRS).

Secondary Outcome Measures

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

Full Information

First Posted
March 13, 2007
Last Updated
November 9, 2007
Sponsor
Epix Pharmaceuticals, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT00448292
Brief Title
A Efficacy Study of PRX-00023 in Patients With Major Depressive Disorder
Official Title
A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of PRX-00023 in Patients With Major Depressive Disorder.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2007
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Epix Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder (MDD)
Keywords
Depression, Major Depressive Disorder, Major Depression, MDD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
330 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
PRX-00023 taken twice daily, escalating from 40 mg to 80 mg to 120 mg
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo taken twice daily, escalating from 40 mg to 80 mg to 120 mg
Intervention Type
Drug
Intervention Name(s)
PRX-00023
Intervention Description
Doses taken two times per day. dose increased at scheduled intervals from 40 mg to 80 mg to 120 mg.
Intervention Type
Drug
Intervention Name(s)
Placebo for PRX-00023
Intervention Description
Doses taken two times per day. dose increased at scheduled intervals from 40 mg to 80 mg to 120 mg.
Primary Outcome Measure Information:
Title
Change from baseline on the Montgomery-Asberg Depression Rating Scale (MADRS).
Time Frame
change from baseline through end of study
Secondary Outcome Measure Information:
Title
Side effects during and immediately following the treatment period
Time Frame
assessed throughout study
Title
changes from baseline on the Hamilton Anxiety Rating (HAM-A) scale
Time Frame
change from baseline through end of study
Title
changes from baseline on the Quick Inventory of Depressive Symptomatology-self report (QIDS-SR)
Time Frame
change from baseline through end of study
Title
changes from baseline on the Clinical Global Impressions (CGI) scale
Time Frame
change from baseline through end of study
Title
responder and remission rates
Time Frame
change from baseline through end of study
Title
changes from baseline on the Changes in Sexual Function (CSFQ) scale.
Time Frame
change from baseline through end of study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Vista Medical Research, Inc.
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85206
Country
United States
Facility Name
Pharmacology Research Institute
City
Encino
State/Province
California
ZIP/Postal Code
91316
Country
United States
Facility Name
Pharmacology Research Institute
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720
Country
United States
Facility Name
Synergy Clinical Research Center
City
National City
State/Province
California
ZIP/Postal Code
91950
Country
United States
Facility Name
Excell Research
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Pacific Clinical Research Medical Group
City
Riverside
State/Province
California
ZIP/Postal Code
92506
Country
United States
Facility Name
AVI Clinical Research
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
Pacific Clinical Research Medical Group
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
GWU Clinical Psychiatric Research Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
CNS Healthcare of Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Atlanta Institute of Medicine and Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Chicago Research Center, Inc.
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60634
Country
United States
Facility Name
Vince and Associates Clinical Research
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66212
Country
United States
Facility Name
Brentwood Research Institute
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71101
Country
United States
Facility Name
Piedmont Neuropsychiatry
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28216
Country
United States
Facility Name
University of Pennsylvannia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
SE Health Consultants, LLC
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States
Facility Name
University of Texas - Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
R/D Clinical Research, Inc.
City
Lake Jackson
State/Province
Texas
ZIP/Postal Code
77566
Country
United States
Facility Name
Northwest Clinical Research Center
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States
Facility Name
Summit Research Network
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs