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Major Depressive Disorder Study In Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00049972
Recruitment Status : Completed
First Posted : November 19, 2002
Last Update Posted : September 11, 2017
Information provided by:

Brief Summary:
A study to obtain safety and tolerability data

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: paroxetine CR Phase 4

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Study Type : Interventional  (Clinical Trial)
Enrollment : 646 participants
Allocation: Non-Randomized
Masking: None (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
Study Start Date : September 2002
Actual Primary Completion Date : September 2003
Actual Study Completion Date : September 2003

Primary Outcome Measures :
  1. The proportion of patients who prematurely terminated treatment due to treatment emergent adverse events

Secondary Outcome Measures :
  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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00049972

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Sponsors and Collaborators
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Study Chair: GSK Clinical Trials, MD GlaxoSmithKline
Layout table for additonal information Identifier: NCT00049972    
Other Study ID Numbers: SB29060.833
First Posted: November 19, 2002    Key Record Dates
Last Update Posted: September 11, 2017
Last Verified: September 2017
Keywords provided by GlaxoSmithKline:
Major Depressive Disorder Open-label discontinued
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors