Panic DisorderNCT00515996
Genetic Abnormalities and Biological Changes of Panic Disorder Patients After Pharmacotherapy
An observational study of Panic Disorder, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
We plan to examine genetic polymorphism of catechol-O-methyltransferase in panic disorder and neurobiological changes of panic disorder patients after 12 weeks of pharmacotherapy with paroxetine. We plan to include 40 panic disorder patients and 40 normal control subjects in this study for 3 years. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Panic Disorder
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2006to Dec 2008
- Phase
- Observational
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Panic disorder
Who cannot join
- Other major medical or psychiatric illnesses
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, 135-710
Tae Geun Kim, BA, 82-2-3410-2975, tggo.kim@samsung.com
Bum-Hee Yu, M.D. & Ph.D.
About this study
Official title: Genetic Abnormalities and Changes of Autonomic Nervous System, Serotonin System, and Neuroendocrine System According to Pharmacotherapy in Panic Disorder
We plan to examine genetic polymorphism of catechol-O-methyltransferase in panic disorder and neurobiological changes of panic disorder patients after 12 weeks of pharmacotherapy with paroxetine. We plan to include 40 panic disorder patients and 40 normal control subjects in this study for 3 years.
- Conditions
- Panic Disorder
- Keywords
- panic disorder, paroxetine, genetic polymorphism, serotonin
- Medical subject headings
- Panic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 2 | paroxetine treatment group vs. normal control group |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2007 (estimated)
- Study startJan 2006
- Study completionDec 2008 (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.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Bum-Hee Yu, M.D. & Ph.D., Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00515996
- Sponsor's protocol ID
- C-A6-418-2
- Status last verified
- Aug 2007
- First submitted
- 13 Aug 2007
- Last updated
- 14 Aug 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Abnormalities and Changes of Autonomic Nervous System, Serotonin System, and Neuroendocrine System According to Pharmacotherapy in Panic Disorder
- ClinicalTrials.gov ID
- NCT00515996
- Acronym / sponsor ID
- C-A6-418-2
- Conditions
- Panic Disorder
- Keywords
- panic disorder, paroxetine, genetic polymorphism, serotonin
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Jan 2006
- Study completion
- Dec 2008 (estimated)
- First posted
- 14 Aug 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.
We plan to examine genetic polymorphism of catechol-O-methyltransferase in panic disorder and neurobiological changes of panic disorder patients after 12 weeks of pharmacotherapy with paroxetine. We plan to include 40 panic disorder patients and 40 normal control subjects in this study for 3 years.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 2 | – | –paroxetine treatment group vs. normal control group |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Panic disorder
Key exclusion criteria (1 listed)
- Other major medical or psychiatric illnesses
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
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 14 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.
Bum-Hee Yu, M.D. & Ph.D. principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Panic Disorder, run by Samsung Medical Center 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 1 inclusion and 1 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 14 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.
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?
Each site lists its own contact: choose the nearest one under Trial locations. 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 14 Aug 2007.