Panic DisorderPhase 4NCT00492414
Costs of Lost Productive Time Among Korean Workers With Panic Disorder and Effect of Treatment With Paroxetine Controlled Release
A Phase 4 study testing Paroxetine CR in people with Panic Disorder, run by Inje University at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Panic Disorder
- What is being tested?
- Paroxetine CR
- How many people
- Not given
- Where
- 1 siteSouth Korea
- Study dates
- Start not givento not given
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul Paik Hospital, Inje University
Seoul, Seoul
Eun-Joo Jung, +82-2-2270-0940, menfipro@naver.com
About this study
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.
- Conditions
- Panic Disorder
- Being tested
- Paroxetine CR
- Keywords
- Panic disorder (PD)
- Medical subject headings
- Panic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paroxetine CRDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Panic DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Inje University
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Investigators
- Jong-Min Woo, Master, Principal investigator, Seoul Paik Hospital, Inje University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00492414
- Sponsor's protocol ID
- COL110010
- Status last verified
- Mar 2007
- First submitted
- 26 Jun 2007
- Last updated
- 8 Aug 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Costs of Lost Productive Time Among Korean Workers With Panic Disorder and Effect of Treatment With Paroxetine Controlled Release
- ClinicalTrials.gov ID
- NCT00492414
- Acronym / sponsor ID
- COL110010
- Conditions
- Panic Disorder
- Keywords
- Panic disorder (PD)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Inje UniversityUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- First posted
- 27 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male or female outpatients aged 20-50 years
- In female, is eligible to enter this study if she is if
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paroxetine CR | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jong-Min Woo, Master principal investigator
Seoul Paik Hospital, Inje University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Paroxetine CR in people with Panic Disorder, run by Inje University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Aug 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eun-Joo Jung (+82-2-2270-0940, menfipro@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2007.