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NCT Number: NCT00448292

A Efficacy Study 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.

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Key information

Conditions

Major Depressive Disorder (MDD) Behavior Behavioral Symptoms Depression Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Vista Medical Research, Inc., Mesa, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PRX-00023

Drug

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

Placebo for PRX-00023

Drug

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

Primary outcomes

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

    Time frame: change from baseline through end of study

Secondary outcomes

  1. Side effects during and immediately following the treatment period

    Time frame: assessed throughout study

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

    Time frame: change from baseline through end of study

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

    Time frame: change from baseline through end of study

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

    Time frame: change from baseline through end of study

  5. responder and remission rates

    Time frame: change from baseline through end of study

  6. changes from baseline on the Changes in Sexual Function (CSFQ) scale.

    Time frame: change from baseline through end of study

Sponsors and collaborators

Lead sponsor

Epix Pharmaceuticals, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Study completion
2007
First posted
Mar 16, 2007
Registry last updated
Nov 14, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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