Clinical trial NCT00448292: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Major Depressive Disorder (MDD)
Keywords: Depression
Major Depressive Disorder
Major Depression
MDD
Lead sponsor: Epix Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2007-03-16
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change from baseline on the Montgomery-Asberg Depression Rating Scale (MADRS).
timeFrame: change from baseline through end of study
Secondary outcomes:
measure: Side effects during and immediately following the treatment period
timeFrame: assessed throughout study
measure: changes from baseline on the Hamilton Anxiety Rating (HAM-A) scale
timeFrame: change from baseline through end of study
measure: changes from baseline on the Quick Inventory of Depressive Symptomatology-self report (QIDS-SR)
timeFrame: change from baseline through end of study
measure: changes from baseline on the Clinical Global Impressions (CGI) scale
timeFrame: change from baseline through end of study
measure: responder and remission rates
timeFrame: change from baseline through end of study
measure: changes from baseline on the Changes in Sexual Function (CSFQ) scale.
timeFrame: change from baseline through end of study
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Vista Medical Research, Inc.
state: Arizona
city: Encino
country: United States
facility: Pharmacology Research Institute
state: California
city: Los Alamitos
country: United States
facility: Pharmacology Research Institute
state: California
city: National City
country: United States
facility: Synergy Clinical Research Center
state: California
city: Oceanside
country: United States
facility: Excell Research
state: California
city: Riverside
country: United States
facility: Pacific Clinical Research Medical Group
state: California
city: Torrance
country: United States
facility: AVI Clinical Research
state: California
city: Upland
country: United States
facility: Pacific Clinical Research Medical Group
state: California
city: Washington
country: United States
facility: GWU Clinical Psychiatric Research Center
state: District of Columbia
city: Jacksonville
country: United States
facility: CNS Healthcare of Jacksonville
state: Florida
city: Atlanta
country: United States
facility: Atlanta Institute of Medicine and Research
state: Georgia
city: Chicago
country: United States
facility: Chicago Research Center, Inc.
state: Illinois
city: Overland Park
country: United States
facility: Vince and Associates Clinical Research
state: Kansas
city: Shreveport
country: United States
facility: Brentwood Research Institute
state: Louisiana
city: Charlotte
country: United States
facility: Piedmont Neuropsychiatry
state: North Carolina
city: Philadelphia
country: United States
facility: University of Pennsylvannia
state: Pennsylvania
city: Charleston
country: United States
facility: SE Health Consultants, LLC
state: South Carolina
city: Dallas
country: United States
facility: University of Texas - Southwestern Medical Center
state: Texas
city: Lake Jackson
country: United States
facility: R/D Clinical Research, Inc.
state: Texas
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
city: Seattle
country: United States
facility: Summit Research Network
state: Washington
Study officials:
References: