NCT00049972|CompletedPhase 4

Major Depressive Disorder Study In Adults

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

GlaxoSmithKline ClinicalTrials.gov

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1 other identifier

SB29060.833

Study Type

interventional

Target

646

Locations

1 country

Sites

Timeline

RegisteredNov 2002

StartedSep 2002

CompletionSep 2003

Brief Summary

A study to obtain safety and tolerability data

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

646

participants targeted

Target at P75+ for phase_4 major-depressive-disorder

Timeline

Completed

Started Sep 2002

Shorter than P25 for phase_4 major-depressive-disorder

Geographic Reach

1 country

71 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1 year study duration

Study Start

First participant enrolled

September 1, 2002

Completed

3 months until next milestone

First Submitted

Initial submission to the registry

November 18, 2002

Completed

1 day until next milestone

First Posted

Study publicly available on registry

November 19, 2002

Completed

10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2003

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2003

Completed

Last Updated

September 11, 2017

Status Verified

September 1, 2017

Enrollment Period

1 year

First QC Date

November 18, 2002

Last Update Submit

September 8, 2017

Conditions

Major Depressive Disorder

Keywords

Major Depressive Disorder Open-label discontinued

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Interventions

paroxetine CRDRUG

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

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.

Contact the study team to confirm eligibility.