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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00492414
Other study ID # COL110010
Secondary ID
Status Recruiting
Phase Phase 4
First received June 26, 2007
Last updated August 7, 2007

Study information

Verified date March 2007
Source Inje University
Contact Eun-Joo Jung
Phone +82-2-2270-0940
Email menfipro@naver.com
Is FDA regulated No
Health authority South Korea: Korea Food and Drug Administration (KFDA)
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group 20 Years to 50 Years
Eligibility 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research


Related Conditions & MeSH terms


Intervention

Drug:
Paroxetine CR


Locations

Country Name City State
Korea, Republic of Seoul Paik Hospital, Inje University Seoul

Sponsors (2)

Lead Sponsor Collaborator
Inje University GlaxoSmithKline

Country where clinical trial is conducted

Korea, Republic of, 

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