NCT00448292

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
330

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2007

Shorter than P25 for phase_2

Geographic Reach
1 country

21 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

March 13, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 16, 2007

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

November 14, 2007

Status Verified

November 1, 2007

First QC Date

March 13, 2007

Last Update Submit

November 9, 2007

Conditions

Major Depressive Disorder (MDD)

Keywords

DepressionMajor Depressive DisorderMajor DepressionMDD

Outcome Measures

Primary Outcomes (1)

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

    change from baseline through end of study

Secondary Outcomes (6)

  • Side effects during and immediately following the treatment period

    assessed throughout study

  • changes from baseline on the Hamilton Anxiety Rating (HAM-A) scale

    change from baseline through end of study

  • changes from baseline on the Quick Inventory of Depressive Symptomatology-self report (QIDS-SR)

    change from baseline through end of study

  • changes from baseline on the Clinical Global Impressions (CGI) scale

    change from baseline through end of study

  • responder and remission rates

    change from baseline through end of study

  • +1 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

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

Drug: PRX-00023

2

PLACEBO COMPARATOR

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

Drug: Placebo for PRX-00023

Interventions

PRX-00023DRUG

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

1
Placebo for PRX-00023DRUG

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

2

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of major depressive disorder

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

Vista Medical Research, Inc.

Mesa, Arizona, 85206, United States

Location

Pharmacology Research Institute

Encino, California, 91316, United States

Location

Pharmacology Research Institute

Los Alamitos, California, 90720, United States

Location

Synergy Clinical Research Center

National City, California, 91950, United States

Location

Excell Research

Oceanside, California, 92056, United States

Location

Pacific Clinical Research Medical Group

Riverside, California, 92506, United States

Location

AVI Clinical Research

Torrance, California, 90505, United States

Location

Pacific Clinical Research Medical Group

Upland, California, 91786, United States

Location

GWU Clinical Psychiatric Research Center

Washington D.C., District of Columbia, 20037, United States

Location

CNS Healthcare of Jacksonville

Jacksonville, Florida, 32216, United States

Location

Atlanta Institute of Medicine and Research

Atlanta, Georgia, 30328, United States

Location

Chicago Research Center, Inc.

Chicago, Illinois, 60634, United States

Location

Vince and Associates Clinical Research

Overland Park, Kansas, 66212, United States

Location

Brentwood Research Institute

Shreveport, Louisiana, 71101, United States

Location

Piedmont Neuropsychiatry

Charlotte, North Carolina, 28216, United States

Location

University of Pennsylvannia

Philadelphia, Pennsylvania, 19140, United States

Location

SE Health Consultants, LLC

Charleston, South Carolina, 29407, United States

Location

University of Texas - Southwestern Medical Center

Dallas, Texas, 75235, United States

Location

R/D Clinical Research, Inc.

Lake Jackson, Texas, 77566, United States

Location

Northwest Clinical Research Center

Bellevue, Washington, 98004, United States

Location

Summit Research Network

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Depressive Disorder, MajorDepression

Interventions

naluzotan

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersBehavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 13, 2007

First Posted

March 16, 2007

Study Start

March 1, 2007

Study Completion

November 1, 2007

Last Updated

November 14, 2007

Record last verified: 2007-11

Locations

US(21)