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Special Drug Use Investigation for PAXIL Tablet (Investigation in Case of Administered From 20mg/Day)

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ClinicalTrials.gov Identifier: NCT01371474
Recruitment Status : Completed
First Posted : June 10, 2011
Last Update Posted : May 22, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
The objective of this survey was to understand the safety and efficacy of PAXIL tablets ("PAXIL", hereinafter) when it was started at 20 mg/day in subjects with depression or in a depressed state.

Condition or disease Intervention/treatment
Panic Disorder Drug: Paroxetine

Study Type : Observational
Actual Enrollment : 1483 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Special Drug Use Investigation for PAXIL Tablet (Investigation in Case of Administered From 20mg/Day)
Study Start Date : April 2006
Actual Primary Completion Date : March 2008
Actual Study Completion Date : June 2008


Group/Cohort Intervention/treatment
Patients prescribed PAXIL
Patients with depression or in a depressed state starting PAXIL at 20 mg/day during study period
Drug: Paroxetine



Primary Outcome Measures :
  1. Incidence of adverse events [ Time Frame: 12 weeks ]
    Incidence of adverse events in Japanese subjects treated with paroxetine tablet based on prescribing information under the conditions of general clinical practice

  2. Efficacy evaluation based on overall improvement [ Time Frame: 12 weeks ]
    The investigator compared the general condition over 1 week before each clinical visit with that over 1 week before the start of treatment with PAXIL.

  3. Efficacy evaluation based on severity by symptoms [ Time Frame: 12 weeks ]
    At every clinical visit, the investigator rated each of the specified symptoms including depressed mood, loss of interests/concerns, anxiety, lack of motivation, physical symptoms, and sleep disorders.

  4. Efficacy evaluation based on Beck Depression Inventory- Second Edition (BDI-II) [ Time Frame: 12 weeks ]
    The investigator asked each subject to fill out the self-administered form of BDI-II at every clinical visit (recommended clinical visit schedule: 1, 2, 4, 8, and 12 weeks after the start of treatment).



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Japanese subjects with depression or in a depressed state who are considered appropriate to prescribe paroxetine tablet starting at 20mg/day according to the prescribing information
Criteria

Inclusion Criteria:

  • Patients with depression or in a depressed state
  • Patients who start taking paroxetine at 20mg a day

Exclusion Criteria:

  • Patients who have been treated with paroxetine prior to this investigation
  • Patients with hypersensitivity to paroxetine
  • Patients taking monoamine oxidase inhibitors (MAOIs) or within 2 weeks of stopping treatment with MAOIs
  • Concomitant use in patients taking pimozide

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 ClinicalTrials.gov identifier (NCT number): NCT01371474


Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01371474     History of Changes
Other Study ID Numbers: 112308
First Posted: June 10, 2011    Key Record Dates
Last Update Posted: May 22, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
Panic Disorder
Anxiety Disorders
Mental Disorders
Paroxetine
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