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OpenTrials
Completed

NCT Number: NCT00049972

Major Depressive Disorder Study In Adults

A study to obtain safety and tolerability data

Completed

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Key information

Conditions

Major Depressive Disorder Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

GSK Clinical Trial Call Center, Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Paroxetine CR

Drug

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

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start
2002
Primary completion
2003
Study completion
2003
First posted
Nov 19, 2002
Registry last updated
Sep 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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