Clinical trial NCT00049972: Major Depressive Disorder Study In Adults
Official title: An Open Label Study Assessing Paxil CR (Paroxetine CR) in Patients With Major Depressive Disorder Who Discontinued Treatment With Selective Serotonin Reuptake Inhibitors or a Selective Serotonin/Norepinephrine Reuptake Inhibitor Due to Intolerability
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Major Depressive Disorder
Keywords: Major Depressive Disorder Open-label discontinued
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2002-11-19
Enrollment: 646
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Primary purpose: TREATMENT

Brief summary: A study to obtain safety and tolerability data


Eligibility criteria: Inclusion Criteria:

* Patient must have primary diagnosis of Major Depressive Disorder (MDD).
* Discontinued a selective serotonin reuptake inhibitor (SSRI)or serotonin-norepinephrine reuptake inhibitor (SNRI) regimen due to intolerability.
* Minimum time frame between last dose of previous antidepressant and initiation of study drug is one week.
* Maximum time frame between last dose of prior antidepressant and initiation of study drug is 2 months.

Exclusion Criteria:

* Patient has previously been treated with the study drug.
* Is experiencing an adverse event attributed to previous SSRI/SNRI use that has not been resolved at least one week prior to Baseline Visit.
* Has a history of seizure disorder.
* Has met criteria for substance abuse or dependence within 6 months prior to Baseline Visit.
* Currently using an antidepressant.
* Currently pregnant.

Primary outcomes:
measure: The proportion of patients who prematurely terminated treatment due to treatment emergent adverse events
Secondary outcomes:
measure: Recurrence rates of adverse events causing intolerability of previous SSRI/SNRI, Adverse event incidence rates, Mean change from baseline in the Beck Depression Inventory-II total score, Proportion of responsers based on teh CGI Global Improvement Item
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: GSK Clinical Trial Call Center
state: Alabama
city: Birmingham
country: United States
facility: GSK Clinical Trial Call Center
state: Alabama
city: Fairfield
country: United States
facility: GSK Clinical Trial Call Center
state: Alabama
city: Mobile
country: United States
facility: GSK Clinical Trial Call Center
state: Alabama
city: Phoenix
country: United States
facility: GSK Clinical Trial Call Center
state: Arizona
city: Little Rock
country: United States
facility: GSK Clinical Trial Call Center
state: Arkansas
city: Little Rock
country: United States
facility: GSK Clinical Trial Call Center
state: Arkansas
city: Anaheim Hills
country: United States
facility: GSK Clinical Trial Call Center
state: California
city: Anaheim
country: United States
facility: GSK Clinical Trial Call Center
state: California
city: Bellflower
country: United States
facility: GSK Clinical Trial Call Center
state: California
city: Cerritos
country: United States
facility: GSK Clinical Trial Call Center
state: California
city: Clovis
country: United States
facility: GSK Clinical Trial Call Center
state: California
city: Encino
country: United States
facility: GSK Clinical Trial Call Center
state: California
city: Petaluma
country: United States
facility: GSK Clinical Trial Call Center
state: California
city: Riverside
country: United States
facility: GSK Clinical Trial Call Center
state: California
city: Sacramento
country: United States
facility: GSK Clinical Trial Call Center
state: California
city: Sacramento
country: United States
facility: GSK Clinical Trial Call Center
state: California
city: San Francisco
country: United States
facility: GSK Clinical Trial Call Center
state: California
city: Temecula
country: United States
facility: GSK Clinical Trial Call Center
state: California
city: Vista
country: United States
facility: GSK Clinical Trial Call Center
state: California
city: Colorado Springs
country: United States
facility: GSK Clinical Trial Call Center
state: Colorado
city: Wilmington
country: United States
facility: GSK Clinical Trial Call Center
state: Delaware
city: Wilmington
country: United States
facility: GSK Clinical Trial Call Center
state: Delaware
city: Boynton Beach
country: United States
facility: GSK Clinical Trial Call Center
state: Florida
city: Delray Beach
country: United States
facility: GSK Clinical Trial Call Center
state: Florida
city: Fort Myers
country: United States
facility: GSK Clinical Trial Call Center
state: Florida
city: Melbourne
country: United States
facility: GSK Clinical Trial Call Center
state: Florida
city: Miami
country: United States
facility: GSK Clinical Trial Call Center
state: Florida
city: Ocala
country: United States
facility: GSK Clinical Trial Call Center
state: Florida
city: Atlanta
country: United States
facility: GSK Clinical Trial Call Center
state: Georgia
city: Idaho Falls
country: United States
facility: GSK Clinical Trial Call Center
state: Idaho
city: Gurnee
country: United States
facility: GSK Clinical Trial Call Center
state: Illinois
city: Greenwood
country: United States
facility: GSK Clinical Trial Call Center
state: Indiana
city: Lafayette
country: United States
facility: GSK Clinical Trial Call Center
state: Louisiana
city: Lake Charles
country: United States
facility: GSK Clinical Trial Call Center
state: Louisiana
city: New Orleans
country: United States
facility: GSK Clinical Trial Call Center
state: Louisiana
city: Prince Frederick
country: United States
facility: GSK Clinical Trial Call Center
state: Maryland
city: Springfield
country: United States
facility: GSK Clinical Trial Call Center
state: Massachusetts
city: Excelsior Springs
country: United States
facility: GSK Clinical Trial Call Center
state: Missouri
city: Kansas City
country: United States
facility: GSK Clinical Trial Call Center
state: Missouri
city: Saint Charles
country: United States
facility: GSK Clinical Trial Call Center
state: Missouri
city: Saint Louis
country: United States
facility: GSK Clinical Trial Call Center
state: Missouri
city: Las Vegas
country: United States
facility: GSK Clinical Trial Call Center
state: Nevada
city: Reno
country: United States
facility: GSK Clinical Trial Call Center
state: Nevada
city: Blackwood
country: United States
facility: GSK Clinical Trial Call Center
state: New Jersey
city: Mercerville
country: United States
facility: GSK Clinical Trial Call Center
state: New Jersey
city: Princeton
country: United States
facility: GSK Clinical Trial Call Center
state: New Jersey
city: Carrboro
country: United States
facility: GSK Clinical Trial Call Center
state: North Carolina
city: Cary
country: United States
facility: GSK Clinical Trial Call Center
state: North Carolina
city: Cincinnati
country: United States
facility: GSK Clinical Trial Call Center
state: Ohio
city: Cincinnati
country: United States
facility: GSK Clinical Trial Call Center
state: Ohio
city: Cleveland
country: United States
facility: GSK Clinical Trial Call Center
state: Ohio
city: Independence
country: United States
facility: GSK Clinical Trial Call Center
state: Ohio
city: Oklahoma City
country: United States
facility: GSK Clinical Trial Call Center
state: Oklahoma
city: Eugene
country: United States
facility: GSK Clinical Trial Call Center
state: Oregon
city: Downingtown
country: United States
facility: GSK Clinical Trial Call Center
state: Pennsylvania
city: Bartlett
country: United States
facility: GSK Clinical Trial Call Center
state: Tennessee
city: Cordova
country: United States
facility: GSK Clinical Trial Call Center
state: Tennessee
city: Selmer
country: United States
facility: GSK Clinical Trial Call Center
state: Tennessee
city: Conroe
country: United States
facility: GSK Clinical Trial Call Center
state: Texas
city: Corsicana
country: United States
facility: GSK Clinical Trial Call Center
state: Texas
city: Dallas
country: United States
facility: GSK Clinical Trial Call Center
state: Texas
city: DeSoto
country: United States
facility: GSK Clinical Trial Call Center
state: Texas
city: Fort Worth
country: United States
facility: GSK Clinical Trial Call Center
state: Texas
city: Galveston
country: United States
facility: GSK Clinical Trial Call Center
state: Texas
city: Richardson
country: United States
facility: GSK Clinical Trial Call Center
state: Texas
city: Sugar Land
country: United States
facility: GSK Clinical Trial Call Center
state: Texas
city: West Valley City
country: United States
facility: GSK Clinical Trial Call Center
state: Utah
city: Lebanon
country: United States
facility: GSK Clinical Trial Call Center
state: Virginia
city: Richmond
country: United States
facility: GSK Clinical Trial Call Center
state: Virginia
city: Kirkland
country: United States
facility: GSK Clinical Trial Call Center
state: Washington
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials, MD
role: STUDY_CHAIR
References: