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NCT00049972 Clinical Trial

Major Depressive Disorder Study In Adults

Major Depressive Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00049972
Other study ID # SB29060.833
Secondary ID
Status Completed
Phase Phase 4
First received November 18, 2002
Last updated September 8, 2017
Start date September 2002
Est. completion date September 2003

Study information
Verified date September 2017
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A study to obtain safety and tolerability data

Recruitment information / eligibility
Status Completed
Enrollment 646
Est. completion date September 2003
Est. primary completion date September 2003
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• paroxetine CR

Locations
Country Name City State
United States GSK Clinical Trial Call Center Anaheim California
United States GSK Clinical Trial Call Center Anaheim Hills California
United States GSK Clinical Trial Call Center Atlanta Georgia
United States GSK Clinical Trial Call Center Bartlett Tennessee
United States GSK Clinical Trial Call Center Bellflower California
United States GSK Clinical Trial Call Center Birmingham Alabama
United States GSK Clinical Trial Call Center Birmingham Alabama
United States GSK Clinical Trial Call Center Blackwood New Jersey
United States GSK Clinical Trial Call Center Boynton Beach Florida
United States GSK Clinical Trial Call Center Carrboro North Carolina
United States GSK Clinical Trial Call Center Cary North Carolina
United States GSK Clinical Trial Call Center Cerritos California
United States GSK Clinical Trial Call Center Cincinnati Ohio
United States GSK Clinical Trial Call Center Cincinnati Ohio
United States GSK Clinical Trial Call Center Cleveland Ohio
United States GSK Clinical Trial Call Center Clovis California
United States GSK Clinical Trial Call Center Colorado Springs Colorado
United States GSK Clinical Trial Call Center Conroe Texas
United States GSK Clinical Trial Call Center Cordova Tennessee
United States GSK Clinical Trial Call Center Corsicana Texas
United States GSK Clinical Trial Call Center Dallas Texas
United States GSK Clinical Trial Call Center Delray Beach Florida
United States GSK Clinical Trial Call Center DeSoto Texas
United States GSK Clinical Trial Call Center Downingtown Pennsylvania
United States GSK Clinical Trial Call Center Encino California
United States GSK Clinical Trial Call Center Eugene Oregon
United States GSK Clinical Trial Call Center Excelsior Springs Missouri
United States GSK Clinical Trial Call Center Fairfield Alabama
United States GSK Clinical Trial Call Center Fort Myers Florida
United States GSK Clinical Trial Call Center Fort Worth Texas
United States GSK Clinical Trial Call Center Galveston Texas
United States GSK Clinical Trial Call Center Greenwood Indiana
United States GSK Clinical Trial Call Center Gurnee Illinois
United States GSK Clinical Trial Call Center Idaho Falls Idaho
United States GSK Clinical Trial Call Center Independence Ohio
United States GSK Clinical Trial Call Center Kansas City Missouri
United States GSK Clinical Trial Call Center Kirkland Washington
United States GSK Clinical Trial Call Center Lafayette Louisiana
United States GSK Clinical Trial Call Center Lake Charles Louisiana
United States GSK Clinical Trial Call Center Las Vegas Nevada
United States GSK Clinical Trial Call Center Lebanon Virginia
United States GSK Clinical Trial Call Center Little Rock Arkansas
United States GSK Clinical Trial Call Center Little Rock Arkansas
United States GSK Clinical Trial Call Center Melbourne Florida
United States GSK Clinical Trial Call Center Mercerville New Jersey
United States GSK Clinical Trial Call Center Miami Florida
United States GSK Clinical Trial Call Center Mobile Alabama
United States GSK Clinical Trial Call Center New Orleans Louisiana
United States GSK Clinical Trial Call Center Ocala Florida
United States GSK Clinical Trial Call Center Oklahoma City Oklahoma
United States GSK Clinical Trial Call Center Petaluma California
United States GSK Clinical Trial Call Center Phoenix Arizona
United States GSK Clinical Trial Call Center Prince Frederick Maryland
United States GSK Clinical Trial Call Center Princeton New Jersey
United States GSK Clinical Trial Call Center Reno Nevada
United States GSK Clinical Trial Call Center Richardson Texas
United States GSK Clinical Trial Call Center Richmond Virginia
United States GSK Clinical Trial Call Center Riverside California
United States GSK Clinical Trial Call Center Sacramento California
United States GSK Clinical Trial Call Center Sacramento California
United States GSK Clinical Trial Call Center Saint Charles Missouri
United States GSK Clinical Trial Call Center Saint Louis Missouri
United States GSK Clinical Trial Call Center San Francisco California
United States GSK Clinical Trial Call Center Selmer Tennessee
United States GSK Clinical Trial Call Center Springfield Massachusetts
United States GSK Clinical Trial Call Center Sugar Land Texas
United States GSK Clinical Trial Call Center Temecula California
United States GSK Clinical Trial Call Center Vista California
United States GSK Clinical Trial Call Center West Valley City Utah
United States GSK Clinical Trial Call Center Wilmington Delaware
United States GSK Clinical Trial Call Center Wilmington Delaware

Sponsors (1)
Lead Sponsor Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary The proportion of patients who prematurely terminated treatment due to treatment emergent adverse events
Secondary 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
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