Back to resultsCosts of Lost Productive Time Among Korean Workers With Panic Disorder and Effect of Treatment With Paroxetine Controlled Release
Primary Purpose
Panic Disorder
Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Paroxetine CR
Sponsored by
About this trial
This is an interventional health services research trial for Panic Disorder focused on measuring Panic disorder (PD)
Eligibility Criteria
Inclusion Criteria:
- Male or female outpatients aged 20-50 years
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)
- 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.
- Subject must have the ability to comprehend the key components of the consent form and provide informed consent.
Exclusion Criteria:
- Subject who has a history of any other major medical or psychiatric illnesses except PD or PD with major depressive disorder.
- Subject who retired or left his job or who plan to retire within two years.
- is a current homicidal or suicidal risk in the investigator's judgement.
- is currently pregnant, lactating or planning to become pregnant within the next 3 months
- is currently participating in any other clinical trial or taking any non-approved or experimental medication.
Sites / Locations
- Seoul Paik Hospital, Inje UniversityRecruiting
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00492414
First Posted
June 26, 2007
Last Updated
August 7, 2007
Sponsor
Inje University
Collaborators
GlaxoSmithKline
1. Study Identification
Unique Protocol Identification Number
NCT00492414
Brief Title
Costs of Lost Productive Time Among Korean Workers With Panic Disorder and Effect of Treatment With Paroxetine Controlled Release
Study Type
Interventional
2. Study Status
Record Verification Date
March 2007
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Inje University
Collaborators
GlaxoSmithKline
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Panic Disorder
Keywords
Panic disorder (PD)
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Paroxetine CR
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Eligibility Criteria
Inclusion Criteria:
Male or female outpatients aged 20-50 years
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)
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.
Subject must have the ability to comprehend the key components of the consent form and provide informed consent.
Exclusion Criteria:
Subject who has a history of any other major medical or psychiatric illnesses except PD or PD with major depressive disorder.
Subject who retired or left his job or who plan to retire within two years.
is a current homicidal or suicidal risk in the investigator's judgement.
is currently pregnant, lactating or planning to become pregnant within the next 3 months
is currently participating in any other clinical trial or taking any non-approved or experimental medication.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eun-Joo Jung
Phone
+82-2-2270-0940
Email
menfipro@naver.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jong-Min Woo, Master
Organizational Affiliation
Seoul Paik Hospital, Inje University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul Paik Hospital, Inje University
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eun-Joo Jung
Phone
+82-2-2270-0940
Email
menfipro@naver.com
12. IPD Sharing Statement
Learn more about this trial
Costs of Lost Productive Time Among Korean Workers With Panic Disorder and Effect of Treatment With Paroxetine Controlled Release
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