Major Depressive Disorder Study In Adults - Tabular View

Tracking Information

First Received Date ^ICMJE

November 18, 2002

Last Updated Date

January 15, 2008

Start Date ^ICMJE

September 2002

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

The proportion of patients who prematurely terminated treatment due to treatment emergent adverse events

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00049972 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Major Depressive Disorder Study In Adults

Official Title ^ICMJE

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

Brief Summary

A study to obtain safety and tolerability data

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Safety Study

Condition ^ICMJE

Major Depressive Disorder

Intervention ^ICMJE

Drug: paroxetine CR

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

646

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00049972

Responsible Party

Study ID Numbers ^ICMJE

SB29060.833

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

GSK Clinical Trials, MD

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

January 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP