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Costs of Lost Productive Time Among Korean Workers With Panic Disorder and Effect of Treatment With Paroxetine Controlled Release

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ClinicalTrials.gov Identifier: NCT00492414
Recruitment Status : Unknown
Verified March 2007 by Inje University.
Recruitment status was:  Recruiting
First Posted : June 27, 2007
Last Update Posted : August 8, 2007
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
Inje University

Tracking Information
First Submitted Date  ICMJE June 26, 2007
First Posted Date  ICMJE June 27, 2007
Last Update Posted Date August 8, 2007
Study Start Date  ICMJE Not Provided
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Costs of Lost Productive Time Among Korean Workers With Panic Disorder and Effect of Treatment With Paroxetine Controlled Release
Official Title  ICMJE Not Provided
Brief Summary Panic disorder(PD)is a disabling psychiatric condition associated with significant impairment in psychosocial, occupational functioning and quality of life, as mentioned by mogotsi et al. So, most patients with panic disorder suffers from the consequences of the impairment in occupational function. This impairment is not only individual problem, but also social one. Since productivity is very important item required to employees, lost productive time among workers with psychiatric illness should be reduced by the proper management. But few data were reported in this field by now.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Panic Disorder
Intervention  ICMJE Drug: Paroxetine CR
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male or female outpatients aged 20-50 years
  2. In female, is eligible to enter this study if she is if

    • Non-childbearing potential(note:women who are 6 months post-menopausal are not considered women of child-bearing potential)
    • child-bearing potential, has a negative urine dipstick pregnancy test, and is practicing a clinically acceptable method of contraception such as oral contraception, surgical sterilization, I.U.D.,systemic contraception, or double barrier contraception(any two of diaphragm/spermicidal foar/condom)
  3. Subject currently meets the diagnosis for PD according to korean version of Anxiety Disorder Interview Schedule for DSM-IV(ADIS-IV) through a comprehensive psychiatric evaluation and not being treated currently.
  4. Subject must have the ability to comprehend the key components of the consent form and provide informed consent.

Exclusion Criteria:

  1. Subject who has a history of any other major medical or psychiatric illnesses except PD or PD with major depressive disorder.
  2. Subject who retired or left his job or who plan to retire within two years.
  3. is a current homicidal or suicidal risk in the investigator's judgement.
  4. is currently pregnant, lactating or planning to become pregnant within the next 3 months
  5. is currently participating in any other clinical trial or taking any non-approved or experimental medication.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Not Provided
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00492414
Other Study ID Numbers  ICMJE COL110010
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Inje University
Collaborators  ICMJE GlaxoSmithKline
Investigators  ICMJE
Principal Investigator: Jong-Min Woo, Master Seoul Paik Hospital, Inje University
PRS Account Inje University
Verification Date March 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP