Major Depressive Disorder Study In Adults - Full Text View

Purpose

A study to obtain safety and tolerability data

Condition	Intervention	Phase
Major Depressive Disorder	Drug: paroxetine CR	Phase IV

MedlinePlus related topics:

Depression

ChemIDplus related topics:

Paroxetine Paroxetine hydrochloride Paroxetine Mesylate Serotonin Norepinephrine Norepinephrine bitartrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Safety Study

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

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	646
Study Start Date:	September 2002

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00049972

Show 72 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators


Study Chair:	GSK Clinical Trials, MD	GlaxoSmithKline

More Information

Study ID Numbers:	SB29060.833
First Received:	November 18, 2002
Last Updated:	January 15, 2008
ClinicalTrials.gov Identifier:	NCT00049972
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

Major Depressive Disorder Open-label discontinued

Study placed in the following topic categories:

Depression

Mental Disorders

Norepinephrine

Mood Disorders

Depressive Disorder, Major

Depressive Disorder

Paroxetine

Serotonin

Behavioral Symptoms

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors

Neurotransmitter Agents

Disease

Molecular Mechanisms of Pharmacological Action

Physiological Effects of Drugs

Psychotropic Drugs

Serotonin Uptake Inhibitors

Pharmacologic Actions

Pathologic Processes

Serotonin Agents

Therapeutic Uses

Antidepressive Agents, Second-Generation

Central Nervous System Agents

Antidepressive Agents

ClinicalTrials.gov processed this record on August 21, 2008

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00049972