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

NCT ID: NCT00448292

Last Updated: 2007-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

330 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2007-11-30

Brief Summary

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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

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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.

Conditions

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Major Depressive Disorder (MDD)

Keywords

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Depression Major Depressive Disorder Major Depression MDD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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1

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

Group Type EXPERIMENTAL

PRX-00023

Intervention Type DRUG

Doses taken two times per day. dose increased at scheduled intervals from 40 mg to 80 mg to 120 mg.

2

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

Group Type PLACEBO_COMPARATOR

Placebo for PRX-00023

Intervention Type DRUG

Doses taken two times per day. dose increased at scheduled intervals from 40 mg to 80 mg to 120 mg.

Interventions

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PRX-00023

Doses taken two times per day. dose increased at scheduled intervals from 40 mg to 80 mg to 120 mg.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of major depressive disorder

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Epix Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Locations

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Vista Medical Research, Inc.

Mesa, Arizona, United States

Site Status

Pharmacology Research Institute

Encino, California, United States

Site Status

Pharmacology Research Institute

Los Alamitos, California, United States

Site Status

Synergy Clinical Research Center

National City, California, United States

Site Status

Excell Research

Oceanside, California, United States

Site Status

Pacific Clinical Research Medical Group

Riverside, California, United States

Site Status

AVI Clinical Research

Torrance, California, United States

Site Status

Pacific Clinical Research Medical Group

Upland, California, United States

Site Status

GWU Clinical Psychiatric Research Center

Washington D.C., District of Columbia, United States

Site Status

CNS Healthcare of Jacksonville

Jacksonville, Florida, United States

Site Status

Atlanta Institute of Medicine and Research

Atlanta, Georgia, United States

Site Status

Chicago Research Center, Inc.

Chicago, Illinois, United States

Site Status

Vince and Associates Clinical Research

Overland Park, Kansas, United States

Site Status

Brentwood Research Institute

Shreveport, Louisiana, United States

Site Status

Piedmont Neuropsychiatry

Charlotte, North Carolina, United States

Site Status

University of Pennsylvannia

Philadelphia, Pennsylvania, United States

Site Status

SE Health Consultants, LLC

Charleston, South Carolina, United States

Site Status

University of Texas - Southwestern Medical Center

Dallas, Texas, United States

Site Status

R/D Clinical Research, Inc.

Lake Jackson, Texas, United States

Site Status

Northwest Clinical Research Center

Bellevue, Washington, United States

Site Status

Summit Research Network

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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EPX-CP-020

Identifier Type: -

Identifier Source: org_study_id