Major Depressive Disorder Study In Adults - Tabular View

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Major Depressive Disorder Study In Adults

This study has been completed.

Study NCT00049972. Last updated on January 15, 2008. Information provided by GlaxoSmithKline

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

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

Brief Summary

A study to obtain safety and tolerability data

Detailed Description

Study Phase

Phase IV

Study Type ^†

Interventional

Study Design ^†

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

Primary Outcome Measure ^†

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

Secondary Outcome 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

Condition ^†

Major Depressive Disorder

Intervention ^†

Drug: paroxetine CR

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

646

Start Date ^†

September 2002

Completion Date

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00049972

Organization ID

SB29060.833

Secondary IDs ^††

Study Sponsor ^†

GlaxoSmithKline

Collaborators ^††

Investigators ^†

Study Chair:

GSK Clinical Trials, MD

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

January 2008

First Received Date ^†

November 18, 2002

Last Updated Date

January 15, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.