Major Depressive Disorder Study In Adults

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00049972
First received: November 18, 2002
Last updated: October 4, 2010
Last verified: October 2010
  Purpose

A study to obtain safety and tolerability data


Condition Intervention Phase
Major Depressive Disorder
Drug: paroxetine CR
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


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
Study Completion Date: September 2003
Primary Completion Date: September 2003 (Final data collection date for primary outcome measure)
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 71 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Chair: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00049972     History of Changes
Other Study ID Numbers: SB29060.833
Study First Received: November 18, 2002
Last Updated: October 4, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Major Depressive Disorder Open-label discontinued

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Paroxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014